As a Clinical Research Specialist, you will play a key role in managing clinical trials from initiation through closeout. Your responsibilities will include preparing and reviewing study protocols, case report forms, and regulatory submissions to ensure alignment with current guidelines and ethical standards.
Key Responsibilities
- Coordinate the daily operations of clinical studies, including site selection, initiation, and monitoring activities
- Ensure accurate and timely collection, entry, and verification of clinical data
- Conduct regular site visits to assess compliance, train staff, and verify patient records
- Collaborate with cross-functional teams to resolve protocol deviations and address audit findings
- Maintain essential study documents in compliance with regulatory requirements
Qualifications
Applicants should hold a degree in life sciences or a related healthcare field, along with proven experience in clinical trial coordination. Familiarity with Good Clinical Practice (GCP) and FDA regulations is essential. Strong organizational skills, attention to detail, and the ability to manage multiple priorities are required.
Effective communication and problem-solving abilities will support successful interactions with investigators, sponsors, and regulatory bodies. Proficiency with electronic data capture systems and clinical databases is highly preferred.
