Department/Unit:
Research Affairs General

Work Shift:
Day (United States of America)

Salary Range:
$54,690.00 - $82,035.00

The clinical research coordinator is responsible for the organization and management of multiple industry sponsored and Investigator initiated clinical trials. The position is accountable for assisting in the timely and accurate conduct of research studies, being concerned primarily for the protection and care of the patient as a research patient from initiation to completion of study. Activities include participating in the study start up and termination procedures, working with study participants in various study tasks including patient recruitment, screening for eligibility, scheduling, physical assessments and biospecimen collection and processing, as well as data collection and study completion activities. The research coordinator serves as the liaison between PI and research site and the study sponsor and other vendors working on the trial.

Job Title: Clinical Research Coordinator

Department:

Division:

Grade: 58

Reports to: Principal Investigator (PI), Senior Clinical Research Coordinator, Clinical Research Nurse, Research Manager, or Practice Administrator/Manager

Revised: May 2025

Minimum Qualifications:

Education:

Practical Nurse training (for LPN)

Bachelor's or a degree in a health-related field. 6 years of related research or clinical experience may be substituted (prefer 2-3 years as a research coordinator).

Licensure, Certification & Registration:

LPN, if applicable
Preferred: Clinical Research Coordinator Certification through the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA)

Experience:

2 years of experience working in a clinical or research setting
Bachelor's degree or higher may substitute for 1 year required experience

Skills, Knowledge & Abilities:

Demonstrates the knowledge and skills necessary to provide care as appropriate to the age and special characteristics of the patients served.
Basic skill competencies including ability to observe, measure, record and report indications of patient's health status.
Possess or successfully complete and maintain Human Subjects Protection training certification
Possess or successfully complete and maintain Shipping of Dangerous Goods certification, if required to ship biological specimens per protocol
Successfully complete institutional credentialing as required: phlebotomy, EKG, point of care testing (urinalysis, urine pregnancy tests, urine drug tests, or any other study required tests), CPR etc.
Self-disciplined with excellent organizational skills and ability to multi-task is essential
Ability to prioritize tasks
Must be reliable, flexible and possess excellent communication skills for all age levels
Ability to interact with study patients and their families comfortably and sensitively.
Extraordinary interpersonal skills and ability to work as part of a multidisciplinary team to include staff within the research department and well as the staff within the treating department and institution, research sponsors and Contract Research Organizations (CRO).
Ability to work a flexible schedule to meet the needs of the research protocol, patient visits, treatments, and testing schedules as well as travel.
Ability to work between different off-site locations as necessary per study requirements
Ability to manage stressful situations- coordination of numerous strict scientific protocol regimens, treatment and data timelines and deadlines, while ensuring compliance with multiple governmental agency regulations and guidelines.
Ability to work in a hectic patient care environment
Familiarity with office equipment and personal computer skills including word processing, excel and database skills.
Familiarity with the internet and social media for patient recruitment purposes.
Familiarity with or successfully complete training on the institution EMR and patient scheduling system

Position Summary:

Essential Duties & Responsibilities, including but not limited to:

Mission, Core Values and Service Excellence: Contributes to the creation of a compassionate and caring environment for patients, families and colleagues through displays of kindness and active listening. Recognizes and appreciates that each employee's work is valuable and contributes to the success of the Mission. Demonstrates excellence in daily work. Actively participates in performance and quality improvement activities and works toward enhancing customer/patient satisfaction. Exhibits positive service excellence skills to patients, visitors and coworkers by greeting others in a friendly manner, keeping customers/patients/colleagues informed about progress, delays and changes. Demonstrates effective teamwork by interacting in a positive manner with colleagues and creating a collaborative work environment. Initiates open communication, conveys positive intent, offers assistance. Contributes to a safe and secure environment for patients, visitors, colleagues by following established procedures and protocols, which address the needs of a diverse patient population and workforce. Demonstrates stewardship by thoughtful and responsible use of resources including maintaining a clean and hospitable environment, starting work on time, displaying a consciousness regarding costs, supplies and department finances. Demonstrates respect for individual differences of each person by acknowledging the essence of each person, appreciating and responding to unique, spiritual, personal and cultural backgrounds of patients, families and colleagues.

Pre-Study Initiation Attend site pre-study visit/qualification visit meetings and Site Initiation Meeting, whether on site or remote Attend Investigator Meeting either remote or at location specified by the study sponsor (requires travel) Complete and submit new protocol feasibility questionnaires with research site information. Review confidentiality forms in conjunction with the ORA and obtain appropriate signatures Assist in study feasibility assessments by considering the patient population, time and personnel requirements, competing trials, ability to maintain patient safety and confidentiality, fiscal soundness, and logistical capabilities including interdepartmental needs, i.e. radiology, operating room, inpatient and outpatient pharmacy. Prepare and submit pre-IRB approval documents for review and approval by the following institutional committees as appropriate: Research Pharmacy, Value Analysis (VAMS), Antibiotic Sub-committee, Radiation Safety Committee, Institutional Biosafety Committee, Departmental Review Committees Prepare and submit regulatory documents required by federal regulations to the Study sponsor/CRO prior to site initiation and maintain during the course of the study 1572 (pharmaceutical trials) Statement of investigator (device trials) Financial Disclosure forms for PI and Sub Investigators (SI) CV and medical license for PI and Sub Investigators (SI) Current Human Subject Protection and Good Clinical Practice (GCP) training certificates for all personnel on the study IATA training certificates (if applicable for the study) Complete the delegation of authority/duty logs to indicate the site personnel involved with the study and update as necessary throughout the course of the study with either new study personnel or personnel that is no longer involved with the study. Prepare the patient informed consent (ICF) and assent (if applicable) by inserting the AMC required language into the sponsors ICF template and submitting to the sponsor for approval prior to IRB submission Prepare for study site initiation visit Schedule visit and all required personnel (PI, sub-investigators, coordinators, research manager, pharmacy, clinical nursing units, operating room staff, etc.) to be present Schedule study specific training visits, Ensure all study required items are on-site (tablets for questionnaires, lab supplies, devices, study medication/investigational products, EKG machine, etc.)

Develop original source data collection worksheets to comply with protocol specific data requirements to include adverse event logs, and medication logs to ensure all required patient data is collected.

IRB Prepare initial IRB submission documents to include: AMC Checklist, IRB application, study protocol, ICF, advertisements, Investigator Brochure, patient diaries (paper or screen shots), patient questionnaires, other patient facing materials Submit the new protocol IRB submission to the ORA through the InfoEd portal and after approval submit to the either WCG through Connexus Portal or approved IRB of record. Prepare and submit annual continuing review reports and site termination report to the IRB of record Prepare and submit any changes to the IRB approved study documents as requested by the study sponsor to include protocol amendments, changes to the ICF, new versions of the Investigator Brochure, new or changes to advertisements of patient facing materials Prepare and submit protocol deviations and/or violations to the study sponsor and IRB as necessary

Patient Interactions Participate in or conduct the informed consent process and HIPAA authorization, per AMC SOP, with research participants through discussion of the study protocol, procedures, timelines, risks, benefits and answering any questions. Obtain the appropriate signatures and dates/time on the ICF form and documents the process and file a copy in the patient's medical record. Assures that patients sign any future amended versions of the consent if applicable. Develop study schedule and required procedures, timelines, and deadlines with study patient and family, the PI and research team. Coordinate patient follow-up study visits, treatments, testing, procedures, and schedules Conduct patient study visits and required assessments per each individual protocol Assess patients for eligibility using the study specific inclusion and exclusion criteria. Perform patient health assessments to include but not limited to: Vital signs, EKG, medication and medical history review as required per protocol and as ordered by the PI/Sub-I, Obtain required biological specimens from patient, i.e., urine, sputum, etc. Perform blood draw to obtain blood specimens Administer study specific scales; i.e. stroke scales, mental assessments, etc. Administer questionnaires to be completed by the patient, i.e. quality of life questionnaires, pain scores, etc., and review for completeness Perform POC testing as applicable per SOP, i.e. urine pregnancy, urine drug test, blood sugar, urinalysis Coordinate/schedule other study required procedures to be done, i.e. physical exam with study provider, radiology, ultrasounds, echocardiograms, follow up study visits etc. Dispense to patient and train patient on completion of study diary, if applicable Review completed patient diaries with patient In conjunction with the provider, provide oral study mediation to the patient or set up/schedule medication infusions or coordinate with nurse to administer study medication injection. Review oral study medication compliance with patient at each visit Collect required data from the patient Procedure Visit -Clinic procedure room, Operating room, Cath lab, Angio suite, etc.

Ensure appropriate study medication or device is ordered for procedure

Ensure appropriate study personnel are scheduled and present for procedure

Transport study medication or device to appropriate location

Review intra operative inclusion/exclusion criteria

Randomize patient to treatment arm, if required

Collect required data before, during and after the procedure

Ensure study procedure requirements are followed

Collect specimens as appropriate and send to sponsor as required

Monitor and communicate on a continuous basis with patients and families to facilitate identification of untoward side effects/adverse events and initiate and coordinate clinical care to manage and minimize harm to research patient

Financial Assist with budget preparation and negotiation Assist with the submission of the contract agreement draft to the ORA for review and approval Assist with obtaining the appropriate signatures on the final Clinical Trial Agreement (CTA) Assist in the preparation and submission of forms to establish a new research cost center Complete departmental signature form, compliance checklist, patient budget form Obtain signatures of PI and Department Chair Submit to ORA finance with the final CTA and budget Assist with Completion of signature card with signatures of PI, Practice manager, department chair (as appropriate) Prepare and submit electronic form to establish research insurance billing account Ensure study patient visits for coordinator and providers are scheduled using the research insurance for billing to the appropriate study Complete Research Grant Registration form to ensure proper billing and submit to appropriate department when scheduling research test/procedure that will be billed to the research grant Complete and submit the Research Encounter form following study office visits for proper billing to the research grant Assist with preparation of invoices to the sponsor for payments per the contract and budget Assist with payment of AMCH/PBS and AMC Faculty Practice/MCPG research services Review in-patient bills and prepare Research Grant Registration form for inpatient research charges and submit to appropriate department to ensure proper billing of research services per contract/ budget Submit patient stipend /travel reimbursement payment information to ORA finance to be set up in Greenphire Pay patient stipends through Greenphire after completion of patient visits per contract/budget and ICF Maintain Greenphire card accountability log and keep cards in a secure location Assist in maintaining log of patient visits, stipends, and invoices.

General Communicate and interact with PI and research team, study sponsors, IRB (AMC IRB, WCG IRB, CIRB, other IRB of record), Office of Research Administration (ORA), appropriate AMC departments (compliance, finance, faculty practice, pharmacy, radiology, laboratory medicine, pathology etc.) and Operating Room, Cath lab, and in-patient units, etc.) Communicate and interact with NIH/NCI cooperative groups (COG, SWOG, ECOG-ACRIN), pharmaceutical companies, device companies, clinical research organizations (CRO's), and AMC departments to coordinate studies, as applicable Knowledgeable on each study protocol specific inclusion criteria, exclusion criteria, timelines, therapy, clinical monitoring oversight, laboratory evaluation, safety monitoring, confidentiality, and data management requirements Comply with all regulatory agency requirements: Food and Drug Administration (FDA), Code of Federal Regulations (CFR), International Council for Harmonization (ICH), -Guideline for Good Clinical Practice, National Institutes of Health (NIH), Office for Human Research Protections (OHRP) Follow AMC and site standard operating procedures (SOPs), regulations and protocol requirements that govern research Complete protocol specific required training, i.e. electronic case report forms (ECFR), study specific equipment for patient testing/procedures, point of care testing, questionnaires/scales/ scoring, electronic/paper diaries, etc. Comply with all regulatory agency requirements and protocol guidelines in implementing clinical trials Prepare, obtain IRB approval, and coordinate advertisement and media coverage efforts with appropriate AMC departments, newspapers, TV ads, and social media outlets Maintain study regulatory documents binder, either paper or electronic, with all copies of regulatory documents, training records, study logs (delegation, accountability, screening, and enrollment, etc.), protocol, investigator brochure, IRB submissions, approvals and approved documents, informed consent, etc. Recruit and screen potential patients through chart review, in-service education for staff and providers, and patient screening programs Register patient as study patient with sponsor using appropriate study website application Verify inclusion and exclusion criteria, access protocol randomization system or AMC Pharmacy to randomize patient to treatment arm Complete and maintain patient screening and enrollment logs provided by the study sponsor or create the logs to be used if not provided. Complete and maintain other study specific logs required per protocol, i.e. specimen tracking forms, consent logs, etc. Coordinate, monitor and manage study medication/investigational devices (IP) per protocol and per physician order and in compliance with protocol and AMC institutional policies and procedures and with AMC pharmacy, if required Review IP against the packing manifest when arrives at site and notify sponsor of arrival, if required per protocol Complete and maintain IP accountability, tracking, dispensing and management logs as needed through the study Maintain the IP in secure storage area at temperature required per IP Maintain required temperature logs either through AMC Centrak system or daily monitoring of the temperature via certified min/max thermometers Notify sponsor of temperature deviations of refrigerators, freezers, and room temperature patient study medication storage protocol Complete and maintain accurate source data documentation to comply with federally mandated regulations using sponsor created worksheets, site created worksheets, lab, EKG, imaging reports, office notes, OP notes, ER records, in-patient records/ notes as needed per protocol. Extract information from source documents and complete paper-based and electronic protocol case report forms (CRFs) per sponsor timelines and maintain data integrity. Review CRFs for queries and answer per sponsor required timelines Assist PI in signing electronic CRFs when required per protocol Review study data for completeness, accuracy, and compliance with protocol requirements Submit CRFs, patient logs, and protocol status reports in compliance with the individual protocol design. Ensures safety of patients by recognizing patient adverse events (AE), serious adverse events (SAE) and unanticipated adverse device effect (UADE) Recognizes the difference between AE and SAE Documents events appropriately and discusses with PI to determine causality to study IP Prepare and maintain accurate and complete source documentation to prepare reports related to AE, SAE , and UADE Prepares SAE/UADE report appropriately for submission to sponsor/FDA and IRB as required by the protocol and federal regulations Ensure Investigation new drug (IND) safety reports are reviewed/signed by PI as required per protocol and submitted to the IRB of record as necessary Protect patient confidentiality by assuring compliance with HIPAA and federal regulations and guidelines regarding confidentiality in storage, release of information and disposal of study records. Coordinate secure maintenance and storage of all patient source records and study documents, supplies and study equipment. Plan, prepare for and coordinate sponsor personnel (monitor) visits for interim monitoring, visiting the pharmacy, audits, protocol training, and site termination visits. Schedule an appropriate space and required study personnel to be available Schedule time for monitor to go to the pharmacy and/or meet with the research pharmacist Send required information to security prior to the monitor arrival, per ORA guidelines Arrange for read only access to AMC EMR systems Ensure patient documents and CRFs are complete for monitor review Ensure regulatory documents/binder are up to date for review Be available as required to answer monitor questions regarding patients and/or regulatory documents Assist in preparation and coordination of audits by the sponsor, IRB, OHRP and FDA Obtain, process, store, and ship clinical laboratory specimens per protocol and in compliance with IATA regulations, to include blood specimens, urine specimen, pathology specimens, pathology slides, etc. Perform phlebotomy to obtain blood samples, if trained or coordinate the appropriate personnel to obtain specimens Request pathology specimens as required per protocol Ensure appropriate collection supplies on site for patient visits per protocol Ensure appropriate shipping supplies on hand Ensure centrifuges are properly maintained, if applicable Process samples according to protocol and ship to lab specified by protocol Coordinate study closure per protocol and regulatory agency guidelines. Ensure patient safety and confidentiality of PHI Prepare all necessary closeout paperwork Complete required summaries per sponsor Return unused supplies or destroy per sponsor instruction and document Return unused and used study IP after monitor review Comply with future audit requests Respond to any post study correspondence Store all records, either paper or electronic, per regulations and site SOP for required time as specified by the contract, protocol, or sponsor Coordinate with AMC Biomedical Engineering to ensure safety of study specific medical equipment used with research patients (e.g. EKG machine, phlebotomy supplies, etc.) and is prepared for emergencies, equipment failure, user errors and reports such events to management Assist PI in creation of database for investigator-initiated study data collection Manage and maintain data collection database integrity Assist PI with requests for data retrieval, evaluation and analysis from databases for investigator-initiated studies Assist PI with submitting protocol modifications to the IRB At all times throughout the study, collaborate with the PI for the protection of human patients in all the above noted manner and always follow FDA, OHRP and GCP regulations and ICH guidelines and institutional policies and procedures. At all times throughout the study, coordinate the patient's health care in the interest of the patient first

Organizational Requirements:

Maintain strict adherence to the Albany Medical Center Confidentiality policy.
Incorporate Albany Medical Center Behavioral Standards and Guiding Principles into daily activities.
Comply with all Albany Medical Center Policies.
Comply with behavioral expectations of the department.
Maintain courteous and effective interactions with colleagues.
Demonstrate an understanding of the job description, performance expectations, and competency assessment.
Demonstrate a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards.
Participate in departmental and/or interdepartmental quality improvement activities.
Participate in and successfully completes Mandatory Education.
Perform all other duties as needed or directed to meet the needs of the department.

Supervisory Responsibilities:

Please check all that apply.
• No supervisory responsibility

☒ Assigns job duties to others while performing similar or related tasks. More than 80% of time spent on own tasks.
• Immediate supervision over a small group of assigned employees that perform similar tasks. More than 20% of time is spent assigning, reviewing or checking staff work.
• Supervises a small group of employees while assigning, checking and maintaining workflow. Makes recommendations as to employment and evaluation of others.
• Assists other supervisors in an advisory capacity
• Instructs and/or trains other employees. May assign, check and evaluate performance during training period.
• Supervises large groups in complex tasks, while providing discipline and enforcement of policies/procedures.
• Manages through others with full responsibility for quality of work, financial considerations and personnel decisions.
• Manages operations via other supervisors or leaders who report in to him/her. Full responsibility for all personnel and financial decisions.

Key Relationships:

Principal Investigator

Sub-Investigators

Patients

Research Manager, if applicable

Pharmaceutical and device Research Sponsors

Departmental Physicians and staff

National clinical research groups

Clinical Research Organizations

Federal Regulatory Agencies

10.

Office of Research Affairs

11.

IRBs

Senior Clinical Research Coordinator

Clinical Research Assistant

Scope/Impact Statement:

Work Schedule:

Indicate either Yes or No as appropriate. Hours of work may be subject to change based upon the needs of the business/department.

On Call: • Yes ☒ No

Shift Rotation: ☒ Yes • No

Weekends: • Yes ☒ No

Travel: ☒ Yes • No

Location Details: Varies based on Department

Is access to reliable transportation required? • Yes ☒ No

Physical Requirements & Environment: Required

For each category, select ONE option from choices below by checking the box at the left of the entry.

Mental and Visual Attention Required

a)
•The position requires basic mental and visual attention much or all of the time

b)
•The position requires periods of concentrated mental and visual attention.

☒

The position requires a high degree of mental and visual concentration.

Physical Exertion

Weight

☒

Nature of work requires lifting or moving light weight (up to 20 pounds).

e)
•Nature of work requires lifting or moving medium weight (over 20 and up to 75 pounds).

f)
•Nature of work requires lifting or moving heavy weight (over 75 pounds).

Dexterity

☒

Flow of work and character of duties require average manual coordination.

h)
•Flow of work and character of duties require above average manual coordination.

i)
•Flow of work and character of duties require high manual coordination.

Range of Motion

☒

Duties require average range of motion.

k)
•Duties require above average range of motion.

l)
•Duties require high range of motion.

Physical Conditions

☒

Performance of duties allows for variation in positioning and tasks.

n)
•Performance of duties requires remaining in position for prolonged periods of time.

Repetitive Motion

☒

Assignments require occasional repetitive motion.

p)
•Assignments require frequent repetitive motion.

q)
•Assignments require constant repetitive motion.

Working Conditions

☒

Working conditions include minimal exposure to elements such as odor, noise, dust, chemicals, temperature extremes or airborne pathogens.

s)
•Working conditions include occasional exposure to elements such as odor, noise, dust, chemicals, temperature extremes or airborne pathogens.

t)
•Working conditions include continuous exposure to elements such as odor, noise, dust, chemicals, temperature extremes or airborne pathogens.

Exposure to Hazardous Materials

☒

Performance of duties generally does not involve exposure to hazardous materials.

v)
•Performance of duties occasionally involves exposure to hazardous materials.

w)
•Performance of duties frequently involves exposure to hazardous materials.

Patient Care Conditions (select ALL that are applicable)

☒

Position entails exposure to blood and body fluids, standard precautions must be used.

☒

Assignments include transporting, transfer and positioning of patients.

z)
•Incumbent must be continuously prepared to prevent a patient fall.

Sensory Requirements (select ALL that are applicable)

aa)

☒

Performance of duties requires the ability to discern and identify colors

bb)
•Performance of duties requires the ability to discern sharp from dull and hot from cold

cc)
•Performance of duties requires the ability to hear soft and loud noises

Patient Care/Patient Contact Designation (check only one of the items listed below)

☒ Position has a direct impact upon health outcomes of the patient.
• Position facilitates the process that may impact patient access to services.
• No patient care/contact and does not facilitate the patient care process or directly impact health outcomes.

This Job Description is intended to describe the general nature and level of work being performed by people assigned to this classification. It is not intended to be construed as an exhaustive list of all responsibilities, requirements, duties and skills required of personnel so classified. Additional duties and responsibilities that are specific to the Department or Unit are identified and maintained by the Manager as an Addendum to the Job Description..

Summary for Job Posting: (For Human Resources Use Only)

Enter position summary details here.

Thank you for your interest in Albany Med Health System!

Albany Med Health System is an equal opportunity employer.

This role may require access to information considered sensitive to Albany Med Health System, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that:

Access to information is based on a "need to know" and is the minimum necessary to properly perform assigned duties. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. Reasonable efforts, consistent with Albany Med Health System policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.

Clinical Research Coordinator

Clinical Research Coordinator

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