Clinical Research Manager

About the role

The Clinical Research Manager (CRM) supports the daily activities of Research team members 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 in their department, working directly under the Director of Research and the principal investigator on various studies.

Responsibilities

• Supervises staff classified as: Study Coordinator I – III, Recruiter/Screener, Lab Technician, and Data (Entry) Coordinators.
• Adheres to compliance activities, including but not limited to:
  • Standard Operating Procedures and accepted clinical practices.
  • Current regulations and guidelines associated with local, state, and federal law, FDA, Code of Federal Regulations (CFR), ICH, and Institutional Review Board (IRB).
• Manages administrative functions:
  • Performs a variety of administrative duties requiring a high level of knowledge of study-specific protocols.
  • Participates in staff hiring and schedules training.
  • Trains other Clinical Research Study Team members.
  • Oversees day-to-day study-related responsibilities, which may vary with each clinical trial.
  • Supervises research staff, ensuring regular reviews, policy adherence, and relevance.
  • Assists the Director of Research in developing recruitment strategies to meet or exceed target enrollments.
  • Distributes and coordinates work assignments.
  • Reviews study protocols with research coordinators, data coordinators, and investigators to clarify roles and responsibilities.
  • Evaluates staff performance.
• Interacts with sponsors and related representatives:
  • Initiates conversations with Clinical Research Associates from Contract Research Organizations (CROs) employed by sponsors.
  • Participates in Site Qualification Visits, Interim Monitoring Visits, Site Initiation Visits, and Close Out Visits.
  • Serves as the main point of contact after the Site Initiation Visit (SIV) for all monitoring activities.
  • Initiates scheduling of participant clinic visits and ongoing study visits.
  • Attends participant visits to ensure protocol-specific activities (clinical procedures, lab tests, etc.) are completed as outlined.
  • Instructs subjects in protocol procedures, medication compliance, diary maintenance, self-rating scales, and schedule of events.
  • Provides close oversight and review of data collection, data entry, and data integrity for all assigned studies.
  • Conducts quality control reviews of subject/patient charts prior to randomization or screen failure to ensure accuracy.
  • Monitors enrollment and provides updates to the clinical team and sponsors.
  • Serves as the point of contact for clinical research staff, patient navigators, and sponsors for study-specific information.
  • Supervises timely and accurate transcription of information on source documents, paper Case Report Forms (CRFs), and electronic CRFs.
  • Responds to data queries and other requests from data coordinators and study monitors in a timely manner.
  • Provides backup for other Clinical Research Coordinators and Data Coordinators as needed.
  • Interfaces with Clinical Research Associates and company personnel assigned to the study.
  • Prepares for monitoring visits to ensure necessary information is available to the monitor.
  • Accompanies the monitor during monitoring visits.
• Organizes evaluation criteria:
  • Specific metrics relating to meeting enrollment goals.
  • Proficiency in managing compliance with study guidelines.
  • Quality Control Metrics, including measures such as a low rate of return for clarifying questions from the CRO.
• Performs other functions and responsibilities as required; duties may change with or without notice.

Skills

• Patient & Customer Focus
• Ethical Conduct
• Flexibility and Initiative
• Personal Effectiveness/Credibility
• Stress Management/Composure
• High attention to detail and strong organizational skills
• Excellent written and verbal communication skills
• Ability to work well independently
• Maintain confidentiality
• Experience with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)
• Strong multitasking, prioritization, and deadline management skills
• Ability to support Principal Investigators (PIs) for multiple projects

Qualifications

• Required:
  • College Degree in the field of sciences.
  • 3+ years of Clinical Research experience.
  • 3+ years of Supervisor experience.
• Preferred:
  • Nursing or Medical Degree.
  • HIPAA compliance certification.
  • Bilingual (Spanish).
  • Clinical Research Certification.