Job Description

Key Functions

1. To assist in the coordination of regulatory correspondence and protocol administration on all departmental clinical research.
 

Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., Surveillance Committee) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration).
Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination.
Assist in coordinating and send outgoing material and correspondence to institutional, state, and/or federal agencies.
Prepare reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, semiannually, and annually for NCI studies).
Inform sponsors and collaborators of regulatory status of protocols at least monthly in formal departmental protocol review meetings.
Collect specimens as outlined in assigned protocols.
Maintain a system for controlling paper flow for protocols and related grants, to include setting up and maintaining reference file system.
Maintain and update protocol reference materials.
Assist in the preparation of scheduled status reports describing interim data, using the Patient Data Management System.

2. To assist research nurses and other clinical research personnel with patient-related activities.

Answer and screen office phone calls effectively and professionally.
Pick up special blood or tissue specimens correctly and in a timely fashion and transport to appropriate locations, as specified by protocols..
Prepare tissue specimens correctly, as specified by protocols.

Pick up special blood or tissue specimens correctly and in a timely fashion and transport to appropriate

3. To transfer patient information into the electronic database and case books.

Review medical records to extract data points.

Assist with data entry into database and casebooks.

Make survival calls and appropriately record the data.
Maintain accurate and up-to-date patient flowsheet, to include entry of toxicities, adverse events, follow-up visits, dose modifications, and any other protocol-required data.

4. To maintain a high level of professional expertise and credibility through educational programs, including on-site training / off-site conferences.

Attend department research meetings and conferences.
Attend approved off-site meetings and conferences.
Supplement education as needed through use of reference materials, lectures, etc.
Be punctual in arriving at all professional functions.
Inform appropriate staff and arrange coverage for necessary functions when absent.

5. To assist in the development of and help maintain an organizational system to coordinate research meetings and research deadlines and inform department staff, as needed..

Generate documents on computer, using word processing, spreadsheet, and other software to produce professional appearance.
Assist in the coordination and preparation of a monthly update for protocol review.
Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.
Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
Enter monitor visits for department, CTRC, Pharm into Clinic Station

Other duties as assigned.

The performance for all expected outcomes is measured by observation by supervisor, reports from faculty and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress. The position also requires one to anticipate needs, to recognize situations requiring assistance and have the ability to refer or perform any necessary tasks, and to comprehend the goals of the department/program and take the initiative in making decisions and taking actions to further these goals.