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Lead Clinical Research Coordinator
2 months ago
Key Responsibilities:
- Oversees, monitors, and directs all aspects of clinical research projects to ensure adherence to established protocols, standard operating procedures (SOPs), and regulatory standards.
- Provides leadership and mentorship to Clinical Research Coordinators, Study Preparation Associates, and Clinical Research Technicians.
- Facilitates training sessions for Clinical Research Coordinators and Research Assistants to enhance their skills and knowledge.
- Contributes to the formulation of study protocols, SOPs, and internal operational procedures.
- Evaluates and resolves quality control and quality assurance findings, and prepares corrective action plans.
- Keeps meticulous records and reviews documentation related to study participants.
- Conducts training on protocols and acts as the primary liaison for various studies and sites.
Qualifications:
- A minimum of 3-5 years of experience in a Clinical Research Coordinator role.
- Certification as a Clinical Research Professional is required.
- In-depth knowledge of Good Clinical Practice (GCP), FDA, and ICH regulations.
- Phlebotomy certification and a relevant postsecondary degree are essential.
- Exceptional organizational skills, keen attention to detail, and the ability to work autonomously.
Essential Skills:
- Outstanding attention to detail and organizational capabilities.
- Strong analytical thinking and excellent verbal and written communication skills.
- Familiarity with research methodologies and medical terminology.
- Highly driven and adaptable, with the capacity to function effectively both independently and within a team.
- Ability to prioritize tasks and adhere to deadlines while maintaining high standards.
- Commitment to confidentiality and a strong work ethic.