What are the responsibilities and job description for the Clinical Research Coordinator position at ORCA Research Group, Inc.?
Company Description
ORCA (Outpatient Research Cardiovascular Alliance) Research Group is a leading site management organization focused on advancing cardiovascular clinical research. In collaboration with our network of clinical sites and medical device manufacturers, ORCA optimizes the research process by expediting contract negotiations, site qualification, and patient screening, enrollment, and follow-up. This streamlined approach accelerates the timeline from site selection to first patient enrolled, expediting the delivery of innovative cardiovascular treatments to patients in need.
Role Description
This role is a full-time role for a Clinical Research Coordinator at ORCA Research Group. This position is a hybrid-based position consisting of remote work from home, travel to the sites within the ORCA network, and some in person company meetings. The Clinical Research Coordinator (CRC) manages the day-to-day activities of clinical trials, ensuring that they comply with regulations, ethical standards, Good Clinical Practice (GCP), and Institutional Review Board (IRB) requirements.
- Oversees the day-to-day operations of the study, including scheduling participant visits, managing laboratory procedures, and reviewing case report forms
- Collects and review data and ensure correct entry into the study database
- Maintains working knowledge of the study protocol(s)
- Conducts or participates in the informed consent process, including discussion with research participants. Obtains appropriate signatures and dates on forms in appropriate places.
- Performs recruitment activities, such as medical record review, to identify prospective patients
- Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria
- Collects documents needed to initiate the study and submits them to the sponsor (i.e., CVs, Medical Licenses, etc.)
- Coordinators participant tests and procedures
- Maintains study timelines
- Maintains adequate inventory of study supplies
- Completes study documentation and maintains study files in accordance with Sponsor requirements
- Maintains effective and ongoing communication with Sponsor, research participants, and the PI during the course of the study
- Works with the PI to manage day to day activities of the study including problem solving and communication
- Schedules subject follow-up visits
Job Requirements
Additional Desired Qualifications
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