Working closely with the Principal Investigators, Clinical Research Manager, and other study staff; the Clinical Research Coordinator I (CRC I) extracts and adapts patient information from the MGH electronic medical record into the associated study electronic data capture systems. The CRC I takes the necessary precautions required to remain complaint with federal (HIPAA/ CFR), institutional policies, and Good Clinical Practice guidelines to ensure security, confidentiality, and validity of patient research data. Performs Investigational Device Accountability, ordering and uploading diagnostic imaging, and ensures protocol compliance.
Must be motivated, organized and able to perform self-directed work. Support to Clinical Research Device Trials
Coordinate the implementation of the research protocol through study closeout of corporate and physician sponsored clinical research studies ensuring data validations, regulatory compliance, and quality control.
Review research subject medical records:
- Collect accurate, verifiable data and source documents.
- Complete case report forms (CRFs) and enter into electronic data capture systems (EDC).
- Report and document safety issues including: adverse events, serious adverse events, and unanticipated device adverse events.
- Respond to queries supplied by the study sponsor in adherence to study-specific time-lines.
- Participate in conducting subject visits (as appropriate), including the administration of protocol specified questionnaires.
- Participate in the informed consent process as appropriate.
- Provide investigational device case support in the OR, cath lab and IR suite to include delivery, tracking, and if needed return, of the device as well as communicate protocol requirements and collect study data.
- Perform Investigational Device accountability. This includes: track and tag all devices, ship unused devices back to the sponsor company, and maintain inventory records.
- Ensure that the protocol required imaging (XRAY, CT, Ultrasound) are done according to the sponsor requirements.
- Assist with maintaining and collecting required essential research documentation for study files.
- Prepare and submit required research documentation to the Institutional Review Board (IRB) for review and approval.
- Review study protocol and study procedure planning to ensure compliance.
- Prepare for and participate in sponsor audits and/or regulatory inspections.
General Office Support:
- Order and upload protocol required images to respective study core labs.
- Scan, file, obtain copies and investigator signatures.
- Compile the department newsletter for distribution.
- De-identify source documents and medical records submitted to sponsors.
- Schedule meetings and protocol trainings for investigators; may attend meetings and record meeting minutes as applicable.
- Assist leaders with financial recordkeeping to include accurately entering data in Oncore and performing invoice reconciliation.
- May attend off-site sponsor requested meetings or other professional meetings.
- Perform other duties as assigned.
- Bachelor's degree required.
- New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.
- Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.
- A Clinical Research Coordinator I does not have any supervisory responsibility.
- A Clinical Research Coordinator II may assist with the training and orientation of new staff members.
Posting ID: 559420340Posted: 2020-06-03