GENERAL SUMMARY OF POSITION:
Under the direction of the Principle Investigator or designee, the Clinical Research Coordinator II (CRC) is responsible for all aspects of collection and management of data for complex treatment, ancillary, and prevention protocols regulated by the FDA or DHHS, and sponsored by federal agencies, foundations, industrial sponsors or UMass Medical School in support of clinical trials.
- Provide support to project through implementation of work plans, and preparation of deliverables. Assist in the documentation of project writing and preparation of material for project meetings.
- Review treatment protocols as they are developed to ensure that the treatment guidelines are consistent throughout the document and the appropriate documentation for the central reviews of research intervention as specified.
- Develop protocol specific tools (e.g., treatment data and/or therapeutic checklists) to aid with data collection and submission.
- Set up the protocol treatment template in the department’s database by abstracting the details of the protocol to aid in on-study patient tracking.
- Extract and transcribe treatment data from hospital and clinical records required to complete study patient’s record and sponsor’s case report forms. Monitors quality and timelines of data submissions.
- Monitors status of all studies in the database and ensures that all patient data (on-study and follow-up) are submitted, and responds to data queries from sponsoring organization, in a timely manner.
- Track and maintain accurate data of studies, accrual, and patient status activity in database.
- Maintains effective working relationships with research nurses and investigators participating in the study.
- Monitors strict adherence to protocols. Assures that cases are being finalized and reviewed by appropriate clinician.
- Prepares regular reports reviewing the status of the study. Reviews protocol requirements with physicians and research nurses. Identifies and resolve issues with protocol compliance. Keeps principal investigator and research nurse aware of any issues on compliance.
- Monitors notices from the Cooperative Group to ensure that protocol document has current amendments. Informs staff and updates database.
- Provides data to study investigators as requested and submits data to the Cooperative Groups for analysis. Runs quality control checks on data prior to transfer.
- Serves as a resource to physician and nurses to locate information for special reports and treatment decisions.
- Adheres to Good Clinical Practice (GCP) guidelines and all human subject protection practices.
- Participates in all office staff meetings. Presents current status of studies assigned.
- Participates in regularly held Protocol Review Committee meetings.
- Participates in the documenting work procedures specific to new studies.
- Perform other duties as required.
- Bachelor’s degree in a scientific or health care field, or equivalent experience
- 3-5 years experience in on-study data management and data collection in a research organization.
- Familiarity with clinical trials highly desirable.
- Professional certification in clinical research highly desirable; otherwise, attainment of certification required within two years of hire.
- Ability to read and understand complex protocols.
- Excellent computer skills including: proficiency in word processing; proficiency in relational databases.
- High degree or organizational and analytical ability to manage data collection and protocol adherence.
- Excellent interpersonal and oral communication skills
- Good writing skills with the ability to compose correspondence
Under the direction of the Principle Investigator or designee
May supervise and direct the activities of data collection employees, Laboratory Technicians & Coordinator I’s
ENVIRONMENTAL WORKING CONDITIONS:
Usual office environment, laboratory, medical, surgical, and off campus study sites