
Diverse Clinical Trials Manager
2 days ago
About the Role:
The Clinical Research Coordinator is responsible for coordinating clinical trials from start to finish. This includes screening, consenting, enrolling, and closing out participants.
- The ideal candidate will ensure that the rights and well-being of research participants are protected throughout the trial.
- They will coordinate with finance, legal, and regulatory teams and assist in preparing CTAs specific to the trials.
Key Responsibilities:
- Ensure accurate and timely completion of source documents, patient files, and Site Master Files.
- Coordinate inventory management, including investigational product handling, storage, dispensing, accountability, tracking temperature, calibration of equipment, sample centrifugation, courier of documents, and lab samples shipment.
- Prepare and submit ethics committee submissions, study progress reports, amendments, protocol deviations, adverse events, and serious adverse events in a timely manner.
- Coordinate monitoring visits with sponsors/CROs and facilitate inspections/audits.
Requirements:
- Bachelor's degree in a related field or equivalent experience.
- Excellent communication, organizational, and problem-solving skills.
- Ability to work independently and collaboratively as part of a team.
Preferred Qualifications:
- Experience working in clinical research or a related field.
- Familiarity with EDC, Inform, and Medidata data capture systems.
- Basic knowledge of GCP and ICH guidelines.
Benefits:
- Competitive salary and benefits package.
- Opportunities for career growth and professional development.
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