GENERAL SUMMARY OF POSITION:
Under the direction of the Principle Investigator or designee, the Clinical Research Coordinator 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.
Participate in the development of protocol specific tools, (e.g., treatment data and/or therapeutic checklists) to aid with data submission
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
Monitor status of all studies in database and ensures that all patient data (on-study and follow-up) are submitted, and respond to data queries from sponsoring organization, in a timely manner
Track and maintain accurate data of studies, accrual, and patient status activity in database
Maintain effective working relationships with research nurses and investigators participating in the study
Monitor strict adherence to protocols. Assure that cases are being finalized and reviewed by appropriate clinician
Review protocol requirements with physicians and research nurses. Identify and resolve issues with protocol compliance. Keep principal investigator and research nurse aware of any issues on compliance
Ensure that protocol document has current amendments. Inform staff and updates database
Provide data to study investigators as requested and submits data for analysis. Run 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
Participate in all office staff meetings. Present current status of studies assigned
Participate in regularly held Protocol Review Committee meetings
Participate 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.
1-3 years experience in on-study data management and data collection in a research organization.
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
ENVIRONMENTAL WORKING CONDITIONS:
Usual office environment, laboratory, medical, surgical, and off campus study sites
Regulatory/IRB submission experience strongly preffered
Oncology experience preferred