Clinical Research Coordinator II
- Location: Boston, MA
- Posted: Oct 24, 2018
This position will assist the Principal Investigators (PIs) and Cardiovascular Clinical Studies Manager in planning and implementing clinical research studies as assigned.
Perform study start-up and continuing review activities-prepares 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 document to FDA as needed.
Coordinate and attend sponsor prequalified visits, monitor visits and study termination visits.
Assist in the recruitment of study participants. Assess potential patients and eligibility for inclusion in a particular protocol requirement. Reviews all eligibility and ineligibility criteria in the patients records. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.
Organize strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required.
Complete follow up with study participants in prescribed settings as required.
Compete record abstraction of source documents, conduct required study measurements and complete study Case Report Forms in accordance with best practice methods. Conduct a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries. Complete 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.
Perform basic laboratory activities as needed.
Maintain 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.
Organize and participate in site visits with the study sponsor to review completeness and accuracy of study documentation.
Maintain 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.
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