Clinical Research Coordinator
Seeking an experienced Clinical Research Coordinator, Full-Time to conduct varied research protocols in a family medicine setting. Four dedicated research investigators/private practice physicians with a strong load of studies.
Looking for a self-motivated, passionate person to join a growing team.
At least 2 years of clinical research experience required. Familiarity with basic medical and research terminology and procedures is required. Phlebotomy/IV experience is preferred.
Under supervision of Clinical Research Manager, Site Director and Principal Investigators, the Clinical Research Coordinator is responsible for managing complex protocols evaluating investigational drugs, devices or other research interventions. Directs and supports the conduct of clinical studies, acting as a liaison between investigator, institutional review board and sponsor, to ensure adherence to the research protocol and Good Clinical Practice (GCP) and Human Subject Protections (HSP) throughout life cycle of study.
Responsibilities to include:
The Clinical Research Coordinator primary responsibilities include conducting study visits and executing all aspects of the study protocol. Other responsibilities included, but are not limited to:
· Thorough adaptation to assigned studies through reading protocols, attending investigator meetings and start-up meetings, and orienting with Primary Investigator
· Strict adherence to study protocol; obtain exemptions when necessary/appropriate
· Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director and Investigators
· Verbally articulate all pertinent issues to the PI or document by email/letter or during meetings
· Nurture physician referral sources, provide chart review materials and aid in EMR review
· Collect initial medical information by interviewing patients and by accessing other appropriate sources
· Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor(s), Auditors and any marketing groups hired by the Sponsor
· Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging
· Maintain timely Oviedo Medical Research source documentation, as well as sponsor required information.
· Dispense and maintain accurate records of study medication
· Educate patients and family regarding their particular study and clinical drug trials in general
· Timely completion of monitor and sponsor queries.
· Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient’s participation in study
· Support recruitment and enrollment efforts, as needed
Job Type: Full-time
CDC Guidelines are being followed in the Research Center and the Private Practice. Patients are prescreened before appointments and staff are screened each morning. Masks are worn.