Position Summary: The Clinical Research Manager is responsible for managing the daily activities of the clinical trial program and plays a critical role in its conduct. They work closely with the Principal Investigator(s), UDP Leadership staff, and other stakeholders to ensure the study adheres to protocols, regulations and standards. They will serve as the primary point of contact for study participants, ensuring their safety and well-being.
Essential Duties and Responsibilities:- Manages activities associated with each clinical research study. Directly involved with study start-up, budget amounts, implementation, and close-outs.
- Creates and nurtures collaborations and partnerships with outside affiliate institutions, clinical research organizations, and pharmaceutical partners.
- Organizes, plans, and controls workflow of the research team within the organization and is responsible for ensuring clinical trials are conducted in compliance with federal, state, and institutional guidelines.
- Responsible for reviews of studies for feasibility and budgets and obtain approval from CFO.
- Responsible for the direction of the department.
- Responsible for ensuring all PI and sub- PI providers understand their compensation for each study and has full responsibility for tracking each payments and how it is applied to provider by patient.
- Serves as the liaison between principal investigator, sponsor/funding source, and facilities required project monitoring and creation and submission of reports as necessary.
- Review laboratory and clinic procedures and evaluations regularly to ensure protocol compliance.
- Ensure that patient enrollment and research activities comply with the established protocols, regulatory and monitoring agency standards, and grant sponsor guidelines.
- Provide recommendations to proactively address complex issues and/or variances with study related activities, ensuring daily management of all administrative and financial functions.
- Ability to understand and maintain discretion and confidentiality related to all aspects of any trial.
- Ability to work with a variety of individuals both inside and outside of the organization.
- Demonstrated ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants, sponsors and internal employees.
- Other duties as assigned
Education and Experience Requirements:- Minimum 3 - 4 years of Medical Assistant experience required, preferably in a dermatology environment.
- Current CCRC (Certified Clinical Research Coordinator) certification required
- Current IATA and GCP certification or ability to procure quickly
- Supervisory experience in a medical setting required
- Experience with EMR systems
- High school diploma or above
- Certified BLS/CPR
Knowledge, Skills and Abilities Requirements:- Strong organizational and communication skills
- Strong knowledge of industry best practices in medical office operations.
- Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to clinical research.
- Demonstrated ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants and sponsors.
- Skill in exercising initiative, judgment, decision-making and problem solving.
- Detail-oriented and able to handle multiple tasks, following through to completion.
Supervisory Responsibilities:This position has supervisory responsibilities.
