Description: Job Summary:
To manage coordination of clinical trials by directing, the collection of quality research data involving human subjects, the direct supervision of an interdisciplinary team of clinical personnel, completing project administration, and the management of daily operations in a clinical research setting.

Essential Responsibilities:

Oversee and direct the implementation and coordination of research project/s: Assure accomplishment of study goals and adherence to study protocols, Protection of Human Subjects regulations, Federal Drug Administration (FDA) standards and regulations, Standards of Good Clinical Practice. Develop, implement, and maintain effective strategies for retaining study participants. Develop and maintain quality control/quality assurance systems. Oversee and direct the collection of high quality research data. Assure adherence to study budgets. Propose appropriate modifications to meet changing study goals. Develop highly functioning project teams. Initiate and direct the development of procedures, consent forms, interview scripts, manuals, forms, relational databases, and tracking systems. Develop and monitor project reports.
Perform functions of a Project Manager 3 on assigned projects: Administer grant/contract pursuant to federal rules and regulations. Develop and manage the project operational budget in consultation with the PI and authorize payment of study related bills. Assure compliance with IRB rules and regulations in submission of consent forms, study materials, adverse events reports, and annual reviews. Serve as clinic liaison to the PI and project staff, CHR departments, funding agency, and coordinating center. Coordinate and participate in all project meetings and conference calls. Facilitate effective interdepartmental collaboration among personnel of diverse backgrounds and expertise. Use appropriate computer programs to assist in data collection, tracking, ordering laboratory tests, procedures, appointments or communication, such as RRS, Health Connect, study specific programs, PAS, and other computer software as needed.
Manage and develop clinic personnel through: Mentoring. Training. Performance reviews. Supporting staff in creation and follow through of developmental plans. Hiring/firing. Compliance with KP/State/Federal HR regulations.
Maintain effective and efficient clinic operations through planning, organizing, controlling and directing activities: Assure that reports reflect complete and accurate data. Adherence to clinical services department budget. Manage functional clinic areas such as reception, radiology (bone mineral densitometry and laboratory. Effective use of clinic space, study supplies, equipment, and project staff. Promotion of participant and customer focused work environment by ensuring staff has the tools to problem solve and take action at point of service. Successful interdepartmental collaboration and communication. Assure development and completion of departmental goals and long range strategies that conform to CHR and KP goals and strategic plans. Assure safe and clean work environment for staff and participants. Development and maintenance of department policies and procedures.
Evaluate and negotiate resources involving both clinic and project budgets. Assure sufficient staffing to accomplish the work effort. Develop & monitor monthly spending plans that match the allotted project dollars. Make staffing decisions based on study needs and dollar calculations. Performs other duties as requested. Basic Qualifications:
Experience

Minimum of two (2) years of experience as a supervisor/manager in a health-related setting or coordinator of a clinical trial.  

Education

BSN, BS, or BA degree, OR four (4) years of experience in a directly related field.
High School Diploma or General Education Development (GED) required.

License, Certification, Registration

Registered Nurse License (in the state where care is provided)

Additional Requirements:

Knowledge of the principles of management and supervision and research regulatory requirements. (See addendum for required degree) or equivalent clinical research experience, in a health-related field or in health care management.
Superb conflict management skills in dealing with a diverse population.
Excellent communication skills, both oral and written.
Demonstrates customer-focused service skills.
Ability to prioritize and problem solve.
Conduct participant interviews.
Generate staff schedules and create clinic appointments.
Skilled at word processing and familiar with spreadsheets.
Demonstrates the ability to counsel and coach staff on performance issues.
Must be able to lift fifty (50) -pound scale calibration weight or project chart stacks.

Preferred Qualifications:

Minimum two (2) years of working with clinical trials or other research projects including data collection from human subjects.
Minimum two (2) years of supervisory experience, including hire/fire responsibilities.
Research methodology and research ethics.
State and federal wage and hour regulations, EEO and other laws, regulations and policies involving personnel management.
Coordination of a national funded study, including recruitment, data collection, and budget management.
Advanced skills in using a computer, including word processing and spreadsheets.
Masters degree in nursing.
Nurse Practitioner (NP) or DNP