Clinical Research Manager

About the role

The Clinical Research Manager (CRM) supports the daily activities of the Research team to ensure all projects are completed on time and in compliance with all standards. The CRM manages a team of various roles and serves as a key knowledge resource, working directly under the Director of Research and the principal investigator on multiple studies.

Responsibilities

• Supervise staff including Study Coordinators (I–III), Recruiters/Screeners, Lab Technicians, and Data Coordinators.
• Ensure compliance with Standard Operating Procedures, clinical practices, and regulations (Local, State, Federal, FDA, CFR, ICH, IRB).
• Manage administrative functions, including study-specific protocols, staff hiring, training, and performance evaluations.
• Oversee day-to-day study-related responsibilities, distribute work assignments, and review protocols with research coordinators and investigators.
• Develop and implement recruitment strategies to meet or exceed enrollment targets.
• Interact with sponsors and representatives, including participating in Site Qualification, Interim Monitoring, Site Initiation, and Close-Out Visits.
• Serve as the main point of contact for monitoring activities post-Site Initiation Visit.
• Schedule and attend participant visits, ensuring protocol-specific activities (clinical procedures, lab tests, etc.) are completed accurately.
• Instruct subjects on protocol procedures, medication compliance, diary maintenance, and self-rating scales.
• Oversee data collection, entry, and integrity, including quality control reviews of subject charts and timely responses to data queries.
• Monitor enrollment and provide updates to the clinical team and sponsors.
• Supervise transcription of information on source documents, paper CRFs, and electronic CRFs.
• Prepare for and accompany monitors during monitoring visits.
• Provide backup support for Clinical Research Coordinators and Data Coordinators as needed.

Evaluation Criteria

• Meeting enrollment goals.
• Proficiency in managing compliance with study guidelines.
• Quality control metrics, including low rates of return for clarifying questions from the CRO.

Competencies

• Patient and customer focus.
• Ethical conduct and high attention to detail.
• Flexibility, initiative, and strong organizational skills.
• Excellent written and verbal communication.
• Ability to work independently and maintain confidentiality.
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
• Strong multitasking, prioritization, and deadline management skills.

Qualifications

• Required: College degree in sciences, 3+ years of clinical research experience, and 3+ years of supervisory experience.
• Preferred: Nursing or Medical Degree, HIPAA compliance certification, bilingual (Spanish), and Clinical Research Certification.