What are the responsibilities and job description for the Clinical Research Manager position at Monroe+Biomedical+Research?
About Monroe Biomedical Research:
Monroe Biomedical Research is a leading clinical research site dedicated to advancing medical science and improving patient care through high-quality clinical trials. We are committed to integrity, growth, and patient-centered care in all aspects of our work.
Position Overview:The Clinical Research Manager is responsible for overseeing the daily operations of clinical trials to ensure compliance with protocols, regulations, and quality standards. This individual will lead a team of Clinical Research Coordinators (CRCs) and support staff, ensuring that trials are conducted efficiently and with a strong focus on patient safety and data integrity.
Key Responsibilities:- Supervise, train, and mentor Clinical Research Coordinators and other clinical staff.
- Manage the execution of multiple clinical trials from startup to closeout.
- Ensure compliance with study protocols, ICH-GCP guidelines, FDA regulations, and site SOPs.
- Review study protocols, budgets, and regulatory documents prior to trial initiation.
- Monitor recruitment and retention metrics and support patient engagement strategies.
- Maintain oversight of study progress, timelines, and quality benchmarks.
- Participate in sponsor and CRO meetings, site qualification visits, initiation visits, and monitoring visits.
- Collaborate with the Site Director and other department heads to resolve operational challenges.
- Identify areas for process improvement and implement best practices to enhance efficiency and compliance.
- Address staff performance issues and foster a culture of accountability and teamwork.
- Ensure all study documentation is accurate, complete, and audit-ready.
- Bachelor’s degree in a health-related field required; advanced degree preferred.
- Minimum of 3-5 years of experience in clinical research, with at least 1 year in a leadership or management role.
- Strong knowledge of clinical trial operations, GCP, and FDA regulations.
- Excellent organizational, leadership, and interpersonal skills.
- Ability to prioritize and manage multiple projects in a fast-paced environment.
- Proficient in clinical research software systems and Microsoft Office Suite.
- CCRP, CCRC, or ACRP certification is a plus.
- Work at the forefront of clinical research with a mission-driven team.
- Opportunity to grow professionally within a rapidly expanding site.
- Make a tangible impact on patients’ lives and the future of medicine.
