Clinical Research Coordinator II
- Location: Boston, MA
- Posted: Nov 21, 2018
This position will assist the Principal Investigator (PIs) and Cardiovascular Clinical Studies Manager in planning and implementing clinical research studies as assigned.
Perform study start-up and continuing review activities-prepare regulatory documents and submission to the IRB (local and WIRB). Participate with PI in writing and revising of protocols, DSMB, Manual of Operations. Assist with application for IND. Submit documents to FDA as needed.
Coordinate and attend sponsor prequalification visits, monitor visits and study termination visits.
Responsible for assisting in the recruitment of study participants. Assess potential patients and eligibility and ineligibility criteria in the patients record. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.
Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required.
Completes follow up with study participants in prescribed settings as required.
Completed record abstraction of course documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. Conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries. Completing data entry as warranted.
Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.
Performs basic laboratory activities as needed.
Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.
Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.
Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk Tests, etc.
Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation.
Maintains inventory of all study supplies.
Bachelors degree or equivalent.
2-5 years experience in research related activities.
BLS certification may be required based on specific role requirements, IATA Hazardous Good Shipping Certification and CITI Human Research Protection Certification.
High degree of organizational talents, data collection and analysis skills.
Requires meticulous attention to detail.
Excellent computer skills including word processing.
Ability to prioritize quickly and appropriately.
Excellent communication and interpersonal skills, including flexibility.
Care in organization and systematic record-keeping.
Previous experience in clinical trials desirable.
- Full Time
Schedule: M-F, 8:30-5