What are the responsibilities and job description for the Senior Clinical Research Coordinator position at Physicians Research Group?
Job Summary
Physicians Research Group is seeking a highly skilled and experienced Senior Clinical Research Coordinator to join our dynamic team. The Senior Clinical Research Coordinator will oversee and coordinate all aspects of clinical trials, ensuring compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and study protocols. The ideal candidate will have strong leadership skills, an in-depth understanding of clinical trial processes, and the ability to manage complex studies from initiation to completion.
Key Responsibilities:
1. Study Management and Coordination
- Oversee and manage the day-to-day operations of multiple clinical trials, ensuring that all studies are conducted according to the protocol, GCP, and regulatory requirements.
- Develop and maintain detailed study documentation, including protocols, informed consent forms, and case report forms.
- Ensure accurate and timely data collection, entry, and reporting in compliance with study requirements.
- Coordinate with internal teams, investigators, sponsors, and CROs to ensure smooth trial execution.
2. Patient Recruitment and Retention
- Lead patient recruitment strategies, including identifying and screening eligible participants.
- Oversee the informed consent process and ensure that participants are fully informed about the trial.
- Monitor and maintain participant retention throughout the study, ensuring patient safety and compliance with the protocol.
3. Regulatory Compliance and Documentation
- Ensure that all clinical trials adhere to FDA, ICH GCP, and IRB/IEC guidelines and regulations.
- Maintain up-to-date regulatory binders, source documents, and patient files in accordance with protocol and regulatory requirements.
- Prepare and submit study-related documents to regulatory authorities and ethics committees, including IRB submissions, amendments, and continuing review reports.
4. Quality Assurance and Monitoring
- Conduct regular internal monitoring to ensure data integrity and regulatory compliance.
- Identify and address protocol deviations, adverse events, and other study-related issues in a timely manner.
- Collaborate with monitors, auditors, and other external parties to facilitate inspections and audits.
5. Leadership and Mentorship
- Assist in the training and development of new team members, ensuring they are well-versed in GCP and study-specific protocols.
- Foster a collaborative and professional work environment focused on teamwork, compliance, and patient care.
6. Communication and Reporting
- Serve as the primary point of contact between the site, sponsor, and study team, ensuring clear and consistent communication.
- Prepare and present study progress reports to investigators, sponsors, and internal leadership.
- Attend study meetings, site initiation visits (SIVs), and close-out visits (COVs) as required.
Qualifications:
Education:
- Bachelor’s degree in life sciences, healthcare, or a related field required or advanced degree
Experience:
- Minimum of 2 years of experience in clinical research, with at least 1 year in a senior clinical research role.
- Extensive experience managing complex clinical trials across multiple therapeutic areas.
- Strong knowledge of FDA regulations, ICH GCP guidelines, and clinical trial best practices.
Skills:
- Excellent organizational and time-management skills, with the ability to prioritize multiple tasks.
- Strong leadership and mentoring abilities.
- Exceptional communication and interpersonal skills, with the ability to work collaboratively with diverse teams.
- Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and Microsoft Office Suite.
Additional Requirements:
- Certifications:
- Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) is preferred, but not required.
- Physical Requirements:
- Ability to sit for extended periods while managing study documentation and data entry.
- Ability to travel locally to study sites, if required.
Benefits:
- Competitive salary based on experience.
- Comprehensive health, dental, and vision insurance.
- Company Retirement plan with company match.
- Paid time off and holidays.
- Opportunities for professional development and career growth.
Application Process:
Interested candidates should submit their resume and a cover letter outlining their qualifications and experience to info@prgresearch.com.