Senior Clinical Research Coordinator

Site: The Brigham and Women's Hospital, Inc.

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

to support new cardiovascular clinical trials

Job Summary
The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.
Responsibilities: Ongoing support of TIMI investigators with all phases of clinical research to include: Trial Initiation; Trial Coordination/Implementation/Maintenance and Trial Close-out.

Trial Initiation: Assist in development of trial protocol IRB application and submit to appropriate authority; prepare and/or review budgets, as required; coordinate and work with ancillary departments/services as needed to successfully execute protocol elements; develop plan for site initiation once IRB protocol approval is received.

Trial Coordination/Implementation: Conduct medical record screening of BWH cardiovascular in-patients and out-patients to identify eligible potential trial subjects; be prepared to approach potential subjects, and/or family members with trial specific information for review/consideration; assist in the recruitment of qualified/interested trial participants; maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow-up trial visits; obtain and process biological samples according to protocol (after completing any necessary training); co-manage with pharmacy all trial medications, including receipt and delivery of same; perform data entry for trials using both manual and electronic data capture; submit all study documentation in a timely manner to appropriate data management and core laboratories; submit any amendments to protocol, or informed consent form(s), to the IRB for review & approval; notify sponsors and IRB of all pertinent AEs (Adverse Events) and SAEs (Severe Adverse Events); perform other procedures related to the trial protocol; review completeness and quality of data with trial monitors; apprise the Principal Investigator and co-investigator(s) on a daily basis, as needed, of overall trial progress to include: subject enrollment, subject scheduling, issues/problems as they develop, subject retention and lost to follow-up metrics. Also, submit/track/amend annual protocol Continuing Reviews to the IRB; serve as an informed resource for trial participants and their families; educate ancillary staff and departments regarding trial protocols: develop trial materials as needed; and orient and train new staff.

Trial Close-out: Assist with preparation and submission of final trial report to the IRB for review. Prepare all documents/files/binders/electronic data for sponsor-initiated or FDA audits.

Other: Maintain department service standards as outlined in the BWH Code of Conduct. Perform other duties as required.
Qualifications - External
1.Bachelor's Degree
2.Three to five years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred
3.Knowledge of federal and institutional policies governing human clinical research
4.Proficiency with PCs and windows-based software, including Word, Excel and data management system
• Be fluent in English and Spanish (preferred)
• Excellent interpersonal skills and ability to work effectively in team environments.
• Strong organizational skills with ability to multi-task
• Possess good judgment skills with ability to interpret information and protocol requirements, and initiate appropriate actions
• Superior written and oral communication skills, to enable working with individuals from various fields of expertise and with trial subjects from various educational/cultural backgrounds
• Accomplished documentation skills with meticulous attention to detail
• Ability to complete tasks with aggressive deadlines and competing priorities
• Ability to safeguard confidential information.
• Comfortable with hospital in-patient and out-patient environments
EEO Statement
Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills, perspectives and ideas, we choose
to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed,
national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other
status protected under law.

Qualifications

Education
Bachelor's Degree Related Field of Study required

Can this role accept experience in lieu of a degree?
Yes

Licenses and Credentials

Experience
Clinical Research or Compliance experience 3-5 years required

Knowledge, Skills and Abilities
- Exceptional time management and organization skills.
- Excellent written and verbal communication skills.
- Knowledge of current and developing clinical research trends.
- Sound interpersonal skills and the ability to mentor others.
- Ability to identify problems and develop solutions.
- Demonstrated ability to successfully manage multiple projects.

Additional Job Details (if applicable)

Remote Type

Onsite

Work Location

350 Longwood Avenue

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range
$49,504.00 - $72,404.80/Annual

Grade
6

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

EEO Statement:

The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.