CRC Miami, FL
b.fernandez@acevedoclinicalresearch.com
The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Manager, the Principal Investigator, and the Medical Director. The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study-specific protocols.
DUTIES AND RESPONSIBILITIES
Administratively and clinically manage an average of six to eight clinical trials
Adhere to Research SOP’s
Adhere to Good Clinical Practices and the study protocols
Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials
Discuss study protocols with patients and verify the informed consent documentation
Provide patient with written communication of their participation (i.e. copy of the signed informed consent)
Ensure patient’s referring physician receives notification of patient’s participation in studies as requested by the patient
Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study
Dispense study medication in a professional and accountable manner following protocol requirements
Collect, process, and ship blood/urine specimens at scheduled patient visits
Perform ECGs and obtain vital signs of patients
Schedule all patient research visits and procedures consistent with protocol requirements
Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
Administer questionnaires/diaries per protocol
Ensure that non-serious and serious adverse events are properly documented and reported
Screen all laboratory results when received and follow protocol procedure regarding abnormal results
Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder
Submit patient reimbursement requests at the conclusion of patient’s participation in the protocol
Ensure the filing and maintenance of all regulatory documents
Schedule monitor visits and set up for monitoring visits prior to monitor’s arrival
Other duties as assigned
Employment Type
Full-time