Job Summary:
We are seeking a dedicated and detail-oriented Clinical Research Coordinator to join our team. The successful candidate will be responsible for overseeing and managing clinical trials, ensuring compliance with regulatory requirements, and maintaining accurate and organized records. This role requires excellent communication skills, a strong understanding of clinical research protocols, and the ability to work collaboratively with a multidisciplinary team.
Key Responsibilities:
• Coordinate and manage clinical trials from initiation to completion.
• Ensure compliance with FDA, GCP, and ICH guidelines.
• Recruit, screen, and enroll study participants.
• Obtain informed consent from study participants.
• Monitor participant progress and maintain accurate records of study data.
• Prepare and submit regulatory documents to the Institutional Review Board (IRB).
• Conduct site initiation, routine monitoring, and close-out visits.
• Develop and implement study protocols and procedures.
• Manage study budgets and resolve billing issues.
• Train and supervise research staff and ensure adherence to study protocols.
• Communicate effectively with study sponsors, investigators, and regulatory agencies.
• Perform data collection, entry, and analysis using relevant software.
Qualifications:
• Bachelor’s degree in a related field (e.g., Public Health, Nursing, Biology).
• Minimum of 2 years of experience in clinical research coordination.
• Strong knowledge of FDA, GCP, and ICH guidelines.
• Excellent organizational and time-management skills.
• Proficiency in data management and analysis software (e.g., SPSS, SAS, R).
• Strong interpersonal and communication skills.
• Ability to work independently and as part of a team.
• Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) is preferred.
Benefits:
• Competitive salary and benefits package.
• Opportunities for professional development and continuing education.
• Collaborative and supportive work environment.
