Summary of Responsibilities:
Under general direction of the Manager, this position is responsible to implement and coordinate oncology research projects conducted through the Oncology Research Department of MedStar Health Research Institute. The Clinical Research Coordinator is accountable to ensure that research is conducted in compliance with all federal, state, local and other regulatory bodies, while effectively coordinating a portfolio of trials, and facilitating participant accrual to appropriate trials.
Principal Duties and Responsibilities:
1) Serve as a resource for oncology research protocols and related issues. Discuss protocol participation with (potential) participants and others as indicated. Confer with sponsors, investigators, and staff regarding study issues.
2) Maintain knowledge of oncology trial requirements, ensuring protocol adherence by clear communication to appropriate persons.
3) Maintain awareness of applicable federal, state, local, and other regulations and guidelines pertaining to departmental research. Implement and apply these regulations in the conduct of research work.
4) Identify and screen potential study participants. Verify participant eligibility according to protocol specific criteria.
5) Effectively facilitate participant accrual to appropriate trials, while ensuring adherence to human subject protection and other research guidelines.
6) Coordinate and finalize the informed consent process.
7) Work with appropriate support staff/departments to ensure study requirements are met.
8) Design and maintain materials that aid in the accurate conduct of the study and in compliance with Good Clinical Practice.
9) Monitor the course of study participants, reporting all required side effects, disease status, and other data related to protocol adherence in a timely and accurate manner.
10) Complete and maintain required records of study activity including, but not limited to: case report forms, research files, adverse event reporting, database records, and thorough source documentation substantiating all reported data.
11) Demonstrate good judgment to make decisions, adjust priorities, and manage schedule to ensure that accurate work is accomplished within the required timepoints.
12) Adhere to protocol specific and local requirements while accurately and completely coding and submitting data and materials in a timely manner.
13) Prepare regular reports of research activity.
14) Attend conferences as assigned, sharing information gained with pertinent staff.
15) Assist in collection, preparation, and analysis of information for institutional special reviews and/or studies;
16) Consistently demonstrate support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner;
17) Perform other duties as assigned.
Education: Bachelors degree in health science or related degree and/or equivalent work experiences such that the objectives of the position are equaled. Nursing strongly preferred.
Experience: At least twelve months of clinical research work in the areas of recruitment, enrollment, monitoring, and reporting data on clinical trial participants is highly preferred. Two or more years of oncology experience strongly preferred.
Complexity and Judgment: Work consists of complex and diversified duties. Associate must routinely make independent decisions, including selection of correct procedures to meet the objectives of the Department.
Interpersonal Skills: Associate m ust represent the Department positively in person, by phone, and via written communication. Must be able to communicate needs and requirements articulately and effectively. Must be able to demonstrate appropriate creativity and initiative to ensure actions that meet the needs of the Department.
Other: Organizational, prioritization, and procedural skills are essential, with the ability to manage multiple priorities and duties with close attention to detail. Must be able to analyze and interpret data, perform mathematical calculations, develop and follow-up on plans, observe and record observations, meet deadlines, respond appropriately to queries, and work independently. General technical and motor skills to include use of office equipment and tools, word processing, data entry, forms design, ability to quickly learn computer programs in use by the Department.
Duties require close proximity to location where administration of chemotherapy is performed.