Clinical Research Coordinator - Danbury CT On-site
Clinical Research Coordinator - Danbury CT On-site
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Job Description
Description
Clinical Research Coordinator Danbury Hospital (Onsite)
Fulltime 40 hours; Monday Friday 8:00 am 4:30 pm
Summary:
Reports to Director of Clinical Trials or Clinical Research Nurse Lead: Collaborates with departmental leadership and research staff in the coordination of all aspects of clinical research studies. Responsibilities include; patient screening and recruitment coordination of care of the research patient protocol implementation data collection and query resolution and submission to the Institutional Review Board (IRB). Coordinates studies in Oncology therapeutic areas. Functions independently in a clinical research setting and responsible for the complete coordination of assigned clinical research protocols from national research agencies and pharmaceutical corporations
Responsibilities:
Major Accountabilities:
- Screens patients for study participation e.g. reviews medical record collaborates with medical & research staff etc. and procures informed consent.
- Maintains accurate and thorough documentation on all source documents and case report forms (CRFs) for each study patient. Enters data. Resolves all patient queries.
- Maintains communication with investigators/researchers patients internal and external collaborators (e.g. consulting physicians Monitors) sponsors federal regulatory agencies and other involved parties as required.
- Participates in investigator coordinator or study initiation meetings accordingly. Coordinates and participates in monitoring visits/audits with regulatory agencies or sponsors.
- Maintains current regulatory (GCP HSR) and study specific required trainings.
- Prepares and submits all study protocols consent forms and other required documents to the Institutional Review Board (IRB).
- Educates hospital staff about protocols through inservices written materials and oneonone interaction for each study and each patient and for general marketing.
- Demonstrates flexibility in daily routine and effectively accommodates for the needs of the job (e.g. early or late patient enrollment).
- Performs procedures including EKG Phlebotomy blood and body fluid sampling packing and shipment of human samples body measurements and examinations within scope of practice and training consistent with clinic and study specific policies/procedures and scope of care under the guidance of the supervisor.
- Fulfills all compliance responsibilities related to the position.
- Performs other duties as assigned.
Requirements:
- Bachelors Degree Allied health professional degree or equivalent experience.
- Minimum of onetwo 12 years experience with EDC and CRFs.
- Minimum Knowledge Skills and Abilities Requirements:Ability to multitask and work as a team and independently.
- Knowledge of Medical Terminology good clinical practice FDA OHRP and HIPAA policies.
- Outstanding interpersonal communication skills.
- Strong attention to detail selfmotivation and good organizational skills.
- Ability to prioritize quickly and follow directions and protocol.
Basic Life Support (BLS) certified or willing to obtain upon employment. Valid drivers license and reliable transportation. PREFER: Certified Clinical Research Coordinator (CCRC) Certified Clinical Research Professional (CCRP) or certified within 2 years. Oncology experience is a plus.
Department: Cancer Research
Exempt: Yes
Salary Range: $27.91 $51.83 Hourly commensurate with experience.
Required Experience:
IC
Employment Type
Full Time
