Clinical Research Manager

JOB SUMMARY

The Clinical Research Manager (CRM) is responsible for supporting the daily activities of Research team members to ensure all projects are completed on time and in compliance with all standards. In addition, the CRM manages the team comprised of various roles and serves as an important knowledge resource in their department. The CRM will work directly under the Director of Research and the principal investigator on various studies.

DUTIES AND ESSENTIAL JOB FUNCTIONS

Supervises staff classified as:

• Study Coordinator I III
• Recruiter / Screener
• Lab Technician
• Data (Entry) Coordinators

Adheres to compliance activities, including but not limited to:

• Standard Operating Procedures,
• Accepted Clinical Practices,
• Current regulations and guidelines associated with
• Local, State, & Federal law,
• Food & Drug Administration (FDA),
• Code of Federal Regulations (CFR),
• The International Conference on Harmonization (ICH),
• Institutional Review Board (IRB)

Manages Administrative functions:

• Perform a variety of administrative duties requiring a high level of knowledge of study-specific protocols,
• Participate in staff hiring and schedule training,
• Train other Clinical Research Study Team members,
• Oversee day-to-day study-related responsibilities, which may vary with each clinical trial.
• Supervise research staff and ensure that they are reviewed regularly, remain relevant, and adhere to policy and procedures,
• Assist Director of Research in developing strategies for recruitment as appropriate to meet or exceed target enrollments,
• Distribute and coordinate work assignments,
• Review study protocol with the Research coordinators, data coordinators, and investigators and ensure everyone is aware of their roles and responsibilities,
• Evaluate staff performance.

Interacts with Sponsors and related representatives to:

• Initiates the conversation with the Clinical Research Associate who works for the Contract Research Organization employed by the sponsor.
• Participate in the Site Qualification Visit, Interim Monitoring Visit, Site Initiation Visit, and Close Out Visit,
• Serve as the main point of contact after the Site Initiation Visit (SIV) for all monitoring activities,
• Initiate scheduling of participant clinic visits and ongoing study visits,
• Attend participant visits, as needed to ensure clinical procedures, lab tests, and other protocol-specific activities are completed as outlined in the protocols,
• Instruct subjects in protocol procedures, medication compliance, concomitant medications, accurate diary maintenance, self-rating scales, and schedule of events,
• Provide close oversight and review of data collection, data entry as well as protection of data integrity for all studies assigned to the research team,
• Provide quality control review of subject/patient charts prior to randomization or screen fail to ensure accuracy of status determination,
• Monitor enrollment and provide enrollment updates for the clinical team and sponsors,
• Serve as point of contact to clinical research staff, patient navigators, and sponsors for study-specific information,
• Supervise timely and accurate transcription of information on source documents, paper Case Report Forms (CRFs), and electronic CRFs,
• Respond to data queries and other requests from data coordinators and study monitors in a timely manner,
• Provide backup for other Clinical Research Coordinators and Data coordinators, as needed.
• Interface with Clinical Research Associate and company personnel assigned to the study,
• Prepare for monitoring visits to ensure the necessary information is available to the monitor, and
• Accompany 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 Contract Research Organization (CRO).

Other functions and Responsibilities

This job description does not cover or contain a comprehensive listing of activities, duties, or responsibilities required for this job. In addition, duties, responsibilities, and activities may change at any time with or without notice.

COMPETENCIES

• Patient & Customer Focus
• Ethical Conduct
• Flexibility
• Initiative
• Personal Effectiveness/Credibility
• Stress Management/Composure
• 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)
• Possess strong skills for multitasking, meeting competing deadlines, prioritizing, and supporting PIs for multiple projects

QUALIFICATIONS

Required

• College Degree in the field of sciences
• 3 years or more Clinical Research experience
• 3 years or more Supervisor experience

Preferred

• Nursing or Medical Degree
• HIPAA compliance
• Bilingual/Spanish

Clinical Research Certification