About the Role
The Clinical Research Coordinator will oversee the day-to-day operations of clinical trials, ensuring they are conducted ethically and according to protocol.
Key Activities
Protocol Familiarization: Understanding the clinical trial protocol, procedures, and objectives.
Regulatory Compliance: Ensuring the study complies with regulatory guidelines, including Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements.
Site Preparation: Setting up study sites with necessary equipment, documents, and supplies.
Recruitment: Identifying and recruiting eligible participants for the study.
Screening: Conducting screening procedures to determine participant eligibility according to the protocol.
Informed Consent: Ensuring participants provide informed consent after fully understanding the study details.
Data Collection: Collecting accurate and timely data during participant visits.
Protocol Adherence: Ensuring all study procedures are conducted per protocol.
Participant Monitoring: Monitoring participant safety, reporting adverse events, and maintaining follow-up schedules.
Specimen Handling: Collecting, processing, and shipping biological samples as required.
Case Report Forms (CRFs): Completing and maintaining CRFs and source documents.
Regulatory Documents: Keeping trial master files and essential regulatory documents updated.
Adverse Event Reporting: Reporting adverse events or protocol deviations to the IRB, sponsor, or regulatory agencies as necessary.
Sponsor Interaction: Liaising with study sponsors, contract research organizations (CROs), and monitors.
Team Coordination: Coordinating activities with the study team, including the PI, nurses, and lab staff.
Participant Communication: Serving as the primary contact for participants regarding study-related inquiries.
Audits and Inspections: Preparing for and participating in audits, inspections, and monitoring visits.
Data Integrity: Ensuring data accuracy and resolving data discrepancies.
Preferred Skills
Good Clinical Practices (GCP), Cardio Pulmonary Resuscitation (CPR), Advanced Life Support (ALS).
Strong organizational, communication, and interpersonal skills.
Education and Experience
Bachelor's degree in health sciences, nursing, biology, or a related field.
1–3 years of clinical research experience.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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