Clinical Research Manager

All Employees of Premier Medical Group are required to demonstrate our core values of Integrity, Respect and Compassion throughout their employment with us, placing patients first. Our employees must commit to always acknowledging our patients positively; showing genuine concern for their needs, identifying themselves and how they and others on the team can help, keeping patients informed and offering thanks for choosing and trusting us with their healthcare needs.

Job Purpose:

Plans, develop, and manage the clinical trials and associated administrative activities of a large, complex medical research study or group of studies. Supervises nursing and/or technical research support staff engaged in the carrying out of research and clinical protocol. Develops operating procedures, and coordinates the procurement and installation of equipment, and materials. Provides direct patient care services as appropriate, and assists with the recruitment, care, and treatment of research subjects.

Essential Functions: (Duties)

• Manage day-to-day activities of clinical research staff and FibroScan clinic: oversee staffing, schedules, procedures, processes and ensure quality and completeness of all appointments and data entry. Update all source documentation working closely with QC to ensure a high-quality source generation following all SOPs and GCP guidelines.
• Oversee and train clinical staff including problem solve patient, procedure or operational issues that may arise. Set clinical staff schedules, set standards for communication and communicate day-to-day activities of research staff. Working closely with QC Identify any issues, trends or errors that need retraining and correction.
• Monitor patient enrollment, source completion and data entry. Identify opportunities to increase patient enrollment, patient retention and increase overall appointments by setting and tracking individual and department goals.
• Interact with and address all external monitoring staff, reviewing source and EDC data and ensuring all queries are addressed and Regulatory issues are resolved in a timely manner.
• Work with and troubleshoot outside vendors and internal departments such as the laboratory, imaging, and billing departments.
• Interact with and address all external monitoring staff, reviewing source and EDC data and ensuring all queries are addressed and Regulatory issues are resolved in a timely manner.

Job Requirements/Qualifications:

Education:

Good Clinical Practice (GCP) Department SOPS and Best Practices, FibroScan Certification, Summit University Series (Courses 1-5, 6-7, 10-11), Medical Assistant Certificate or higher, PMG Core Clinical Level 1 or Equivalent, Research operational experience, management and or supervisory experience and skills

Experience:

Minimum 3 years clinical research experience hitting workload metrics

Minimum of 2 years manager or supervisory experience

Knowledge and Skills:

• Ability to develop and deliver presentations.
• Knowledge of accreditation and certification requirements and standards.
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to observe, assess, and record symptoms, reactions, and progress.
• Ability to maintain quality, safety, and/or infection control standards.
• Skill in the use of personal computers and related software applications.
• Knowledge of the principles and procedures of clinical research.
• Knowledge of human resources concepts, practices, policies, and procedures.
• Knowledge of inventory management practices.
• Skill in organizing resources and establishing priorities.
• Knowledge of drugs and their indications, contraindications, dosing, side effects, and proper administration.
• Ability to provide direct nursing care and consultation to patients.
• Knowledge of contracts, budgets and reporting requirements both internally within Premier and externally to Sponsors and strategic partners.
• Ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments.
• Ability to make administrative and procedural decisions and judgments on sensitive, confidential issues.
• Ability to recruit, evaluate, and instruct clinical research subjects and volunteers.
• Ability to prepare and process laboratory samples using established protocols.
• Ability to develop and manage nursing care plans.

Licenses/Certifications:

FibroScan Certification, Summit University Series (Courses 1-5, 6-7, 10-11), Medical Assistant Certificate or higher

Working Conditions and Physical Demands:

• No or very limited physical effort required.
• No or very limited exposure to physical risk.
• Work is normally performed in a typical interior/office work environment.
• Will work with blood or blood-borne pathogens and will require OSHA training.