The employee serves as a clinical research coordinator (CRC) or study coordinator of clinical research studies. The CRC will be responsible for the overall management of an assigned clinical trials portfolio. The position requires the ability to develop and maintain a detailed knowledge of all assigned protocols and the ability to perform functions with a high degree of independence. Responsibilities include serving as a consultant to physicians, nurses, and other staff; planning and implementing studies; ensuring adherence to protocol requirements; ensuring adherence to Federal (FDA and OHRP) and State regulations pertaining to protection of human subjects; serving as the liaison with the study Sponsor; preparing budgets and fiscal management of the studies; developing, managing, and monitoring effective data management procedures; ensuring up-to-date and accurate data collection and reporting; managing protocols on a “day-to-day” basis; ensuring all required materials are submitted for IRB continuing review; maintaining organized regulatory, operational, and financial files; and conducting study visits as per protocol requirements. It is expected that the CRC will develop detailed knowledge of all assigned studies. Strong emphasis is placed on knowledge of regulations pertaining to research and Good Clinical Practice; skill at managing multiple projects; and ability to communicate effectively and work in multiple teams.
Essential Job Duties:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Supervises, implements, and coordinates clinical trials conducted through the Department.Ensures trials are conducted in accordance with Federal regulations and guidance (Food & Drug Administration [FDA] and Office for Human Research Protections [OHRP]), Good Clinical Practice [GCP]), and institutional policies and procedures.
- Coordinates study visits and study related interventions with support services (Pharmacy, Laboratory, Imaging, etc.) as required by the protocol. Primary liaison with study investigators and study sponsor representatives regarding protocol,
- Initiates and maintains perpetual readiness of subject records and case report forms for audit by Federal regulators and Sponsors. Designs, develops and distributes study related training materials for each assigned protocol.
- Ensures that staff members working on an assigned protocol, in all departments impacted by study, are adequately trained on the protocol. Coordinates and prepares materials necessary for site initiation meetings, investigator study meetings, monitoring visits, and audits.
- Completes site feasibility questionnaires of newly proposed studies at AAMC in conjunction with Independently uses existing databases and site information to advise on ability to enroll and feasibility of conducting newly proposed studies at AAMC. Independently confirms participant eligibility as outlined in protocol document through review of medical history and verification of documentation.
- Coordinates and implements recruitment and retention methods to be used for studies to ensure projected recruitment targets are achieved. Responsible for coordination, preparation and submission of study start-up documents and other related documents.
- Develops protocol specific calendars in Clinical Trials Management System to ensure that invoicing and reimbursement for all assigned studies is recorded in a real-time basis. Manages protocol to prevent or minimize the potential for protocol violations or deviations.
- Coordinates or oversees: data collection and management; resolution of queries and errors; adequacy of source documents; development and use of Case Report Forms (CRFs); registration and management of serious or unexpected adverse events; and conduct of monitoring and auditing visits.
- Coordinates or oversees the final study requirements, including trial closure, audit preparation, communication with authorities and other disciplines involved, assisting in the final study report, and contribute to articles and posters reporting the research results.
- Works in conjunction with departmental leadership in the hiring and training of new team members, student interns, and research fellows. Maintains a high level of professionalism inside and outside of the organization while serving as a representative of the Anne Arundel Health System Research Institute.
- Two years of specialized experience as a study coordinator.
- Current certificate in research is preferred.
Working Conditions, Equipment, Physical Demands:
There is a reasonable expectation that employees in this position will be exposed to blood-borne pathogens.
Physical Demands –
Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the worker sits most of the time, the job is rated for light work.
The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.
The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as deemed necessary.