Manager of Clinical Research

Description

POSITION SUMMARY

The Managerof Clinical Research is responsible for overseeing the implementation of clinical trials conducted within all departments of the Health Center. The Managerof Clinical Research ensures compliance with all research standards, ethics and regulatory requirements, coordination of projects within and between departments, and coordination of projects with sponsoring organizations.

KC CARE CULTURE CODE

KC CARE follows a culture code in all we do. Our code determines how we work, treat each other, and move health equity forward. As an employee of KC CARE, you will:
• Put patients first, always
• Treat all people with dignity, respect, and kindness
• Create safe places for others to share their voice; encourage creativity
• Always strive for improvement; keep learning
• Own your work, action, and mistakes - no one is perfect
• Have fun - work should be fun and we want you to have fun at KC CARE

ESSENTIAL DUTIES AND RESPONSIBILITIES
• Collaborates with Chief Medical Officer (CMO), Principal and Sub-Investigators to assess feasibility of potential trials.
• In collaboration with CMO and Principal Investigators, reviews and negotiates all clinical trial confidentiality agreements, contracts and budgets.
• Assures all staff participating in clinical trials has appropriate training and certifications. (e.g., Human Subjects, IATA Training, GCP and Study Specific Training.)
• Assures conduct of clinical trials adheres to all regulatory requirements and Good Clinical Practice guidelines.
• Acts as liaison and coordinates communication with sponsoring organizations, Clinical Research Organizations (CRO) representatives, Institutional Review Boards and other external partners
• Manages IVRS (interactive voice response systems) and randomization codes per protocol requirements.
• Manage all databases and electronic data capture systems related to clinical trials.
• Documents and addresses Adverse Events, IND Safety Letters, and Serious Adverse Events per sponsor requirements
• Maintains protocol regulatory binders.
• Manages Institutional Review Board (IRB) communication for each protocol including applications, amendments, continuations, and reports, including SAE's and IND Safety Reports.
• Coordinates study supply inventories, including ordering and documentation.
• Manages drug accountability for assigned protocols, complying with the sponsor requirements.
• Manages laboratory requirements of protocol, including requisitions, education of phlebotomy staff, shipping and review of results by the Principal Investigator or Sub-Investigator.
• Assures that lab specimens are processed and shipped per protocol.
• Attends investigator meetings and protocol-specific meetings as required by each sponsored trial.
• Coordinates clinical trial activities between clinic staff and external partners.
• Acts as liaison and coordinates communication with sponsoring organizations, Clinical Research Organizations (CRO) representatives, Institutional Review Boards and other external partners.
• Coordinates sponsor monitoring visits, including scheduling and follow-up activities.
• Collaborates with internal partners for patient recruitment such as case management, prevention, peers, nursing and health center providers.
• Assures compliance with all local and central institutional review boards.
• Assures compliance with FDA and other regulatory organizations for the safe and ethical conduct of clinical research.
• Participates in all health center wide risk and compliance activities and assures compliance among the clinical research staff.
• Assesses new clinical trials for their financial feasibility
• Coordinates the reconciliation of study income and payments in collaboration with the office of Finance.
• Along with the CMO and Principal investigators, prospects for new clinical trials that could benefit the health center and the community.

LEADERSHIP COMPETENCIES

People Management - Identifies strengths and weaknesses, evaluates workloads, and splits tasks among team members accordingly; accurately identifies and responds to the expression of feelings to prevent conflict and develop relationships to provide the psychological safety needed to thrive in the workplace; clearly defines employee roles and responsibilities; establishes common ground while also nurturing individual talents, meaningfully connecting teammates in ways that encourage further interaction; sets standards for communication and models those behaviors; leads by example.

Operations Management - Directs and guides operations in alignment with the KC CARE's overall mission, vision, and culture code; ensures the execution of efficient processes to maximize KC CARE's resources.

Strategic Leadership - Balances the day-to-day with future plans; creates better processes and solutions and motivates others to do the same; creates teams that support strategic initiatives and propels them forward; effectively communicates strategies internally and externally; creates a culture to support strategies and provides mechanisms to implement them; fosters buy-in and enthusiasm with employees.

MINIMUM REQUIREMENTS
• Bachelor's degree in a healthcare field
• Five years' experience in clinical research
• Previous experience working with Institutional Review Boards
• Excellent computer skills in Microsoft Word, Excel, Teams and Outlook

PREFERRED REQUIREMENTS
• Certification as Clinical Research Professional
• Master's degree in a healthcare field

WORKING CONDITIONS AND DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working Conditions

General working conditions are in a healthcare facility. As such, there is a potential exposure to virus, disease, and infection from patients while performing the duties of this job. May experience traumatic situations including psychiatric traumatized and deceased patients. Travel may be expected to community meetings, client homes, or other agencies.

Physical Demands

While performing duties of this job, employees are regularly required to sit, walk, and stand; talk and hear; both in person and by telephone; use hands repetitively to finger, handle, feel, or operate standard office or clinical equipment; reach with hands and arms; and occasionally lift up to 20 pounds.

Mental Demands

While performing the duties of this job, employees are regularly required to use written and oral communication skills; read, analyze, and interpret data, information and documents; analyze and solve non-routine and complex problems; use math and mathematical reasoning; observe and interpret situations; learn and apply new information or skills; perform highly detailed work on multiple, concurrent tasks; work under intensive deadlines with frequent interruptions; and interact with others outside of their department.

Duties and responsibilities, as required by business necessity may be added, deleted, or changed at any time at the discretion of management, formally or informally, either verbally or in writing. Scheduling, shift assignments, and location may be changed at any time, as required by business necessity.