GENERAL SUMMARY OF DUTIES : Responsible for directing and supporting the daily operational and administrative functions of clinical study operations of the in-patient unit with a focus on project and resource management. Ensures the implementation of policies and procedures of the clinic and regulatory agencies are met or exceeded.

REPORTS TO: Chief Executive Officer

SUPERVISES: Coordinators, Research Assistants, Nurses and PRN staff

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Leading the daily clinical operations for all studies to include:

• Manage the project to those commitments
• Assigns studies to clinical staff based upon experience and workload.

• Contributes to the definition of the organization’s strategic plan.
• Maintaining overall protocol timeliness and study enrollment goals.
• Collaborate with other experts to ensure that studies are conducted efficiently and are completed with the highest quality standards and outcomes.
• Provides direction to all clinical staff as well as overseeing external vendors including contract research organizations, sponsors, and monitors.
• Participates and prepares for all study initiations, close-out meetings, monitor visits, and sponsor audits.
• Acts as liaison between the sponsor, investigator, and study coordinators to address issues relating to protocol compliance.
• Works with clinical staff and management to ensure enrollment goals are met.
• Review clinical study documentation in adherence to protocol, ensuring compliance.
• Participates in the selection and hiring of all study staff.
• Responsible for and oversees formal training of study staff.
• All other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES

• Thorough understanding of clinical research terminology, good clinical practices, regulatory and ethical guidelines, and regulations.
• Strong leadership, personnel management, and supervisory skills.
• Strong customer service and client relationship skills.
• Strong project management skills.
• Excellent organization and time management skills with a strong ability to prioritize and multi-task across competing demands.
• Excellent verbal/written communication skills with evidence of effective collaboration across businesses and functions.
• High-level computer skills.

EDUCATION

• BA/BS is required. Advanced Degree Preferred.

EXPERIENCE

• 5 years of direct project management required. Management experience in a clinical research setting is preferred.

CERTIFICATE/LICENSE - N/A

PHYSICAL DEMANDS/WORKING CONDITIONS - Requires prolonged walking, standing, some bending, stooping, and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-borne pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities, situations, and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.