Job Description

Under the direct supervision of the Clinical Research Program Manager or the Principal Investigator, we are seeking a Research Program Coordinator (RPC) who will be responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols at the Sidney Kimmel Comprehensive Cancer Center and participating sites. The RPC is responsible for the organization, entry, maintenance and accuracy of all patient's clinical research data in a timely and ongoing manner. This is an intermediate level position in managing clinical trials and/or registry databases within the Genitourinary (GU) Oncology Clinical Research Program.



Specific Duties & Responsibilities

Coordinate protocol implementation of several complex clinical research studies.
This will include interventional and observational studies.
The Research Program Coordinator will receive the appropriate training and supervision to participate in these projects.
Ensure that research protocols are carried out correctly, including all documentation, administrative, and regulatory issues.
Work with others in a research team environment.
Responsible for screening, recruiting, and obtaining informed consent from potential candidates for research studies.
Assist Principal Investigators in developing and implementing study operating procedures related to recruitment, retention, study visits and specimen bank collection.
Coordinate the management of activities related to the pre-award and post award sponsored research projects according to established departmental and IRB process, including new and renewal funding submissions.
Responsible for the oversight of data collection, database entry and accurate record keeping of all study related information.
Coordinate study participant compensation and reimbursement for travel and other expenses.
Assist Principal Investigators and financial staff in identifying and resolving compliance issues for sponsored research.
Coordinate study clinic visits.
Comply with administrative pieces of research, institutional review board (IRB) mandates, REDCap data entry, and related issues.
Ensure adherence to protocols.
Guide patients through study activities.
Perform study dictated activities using independent judgment as delegated by the PI.
Oversee record management for research studies.
Serve as resource for clinicians involved in study in regard to protocol requirements.
Abstract medical data from charts requiring interpretation.
Prepare reports relating to study accrual, study trends, and efficiency related issues.
May assist in coordinating study meetings for coordinating center and maintain a good line of communication with study leadership and Dermatology department faculty and staff.
Participate in study meetings and provide update on protocol implementation status and make recommendations on operational issues.
Prepare for study audits.
Ensure upkeep of office supplies, devices, and materials.
Maintains good working knowledge of all assigned protocols and reporting requirements. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library.
Maintains electronic and/or physical regulatory binder for each assigned protocol.
Prepares and submits annual renewal requests, amendments, and adverse event reports with clinical input according to IRB and Sponsor requirements.
Adheres to all protocol requirements to ensure the validity of the clinical research data.
May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. Will design and create protocol- specific case report forms as needed.
Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements. Confirms patient registrations and
relevant data points in databases for the SKCCC Clinical Research Office and Oncology Information Systems.
Maintains an electronic or physical research chart for each patient. Collects, enters and compiles clinical data from a variety of sources. Ensures accuracy and timeliness of data so that information may be used by the physician in treatment planning, presentations, and publication.
Verifies scheduling of patient appointments, tests, and follow-up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements. May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress.
Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and registry requirements.
Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary. Writes responses to audit reports with input from the Principal Investigator.
Completes minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies. May instruct introductory level clinical research personnel in these guidelines and policies.
Assists with study budget and invoice preparation as needed.


Minimum Qualifications
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.


Specific Requirements

Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.
This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s).
It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.