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Account/Position No.:                        E35020/E256529/502600                       Level 14

Position Title:                                      Clinical Research Manger

Department:                                        College of Nursing, Office of Research

Expectations for All Employees

East Tennessee State University pursues its mission based upon core values.  An employee's job performance must support and exhibit the university's core values:

PEOPLE come first, are treated with dignity and respect, and are encouraged to achieve their full potential;

RELATIONSHIPS are built on honesty, integrity and trust;

DIVERSITY of people and thought is respected;

EXCELLENCE is achieved through teamwork, leadership, creativity, and a strong work ethic;

EFFICIENCY is achieved through wise use of human and financial resources; and

COMMITMENT to intellectual achievement is embraced.

Function of Position

To coordinate and facilitate all aspects of clinical trials implemented by Principal Investigators at the Veterans Administration Medical Center (VAMC), Mountain Home and other hospital or clinic sites.

Essential Functions

-          Coordinates and facilitates all aspects of clinical trials implemented by Principal Investigators at the Veterans Administration Medical Center (VAMC), Mountain Home and other hospital or clinic sites.

-          Performs complex and comprehensive clinical trials.

-          Participates in the planning, development, budget monitoring and implementation of assigned clinical trials.

-          Engages in problem solving to include clinical research agreements and regulatory institutional assurance requirements.

-          Communicates good clinical practices to interdisciplinary personnel.

-          Ensures compliance with multiple regulatory guidelines.

-          Designs, implements, evaluates, and maintains a quality assurance and tracking process for College of Nursing Faculty Practice clinics.

Secondary Functions:

-          Ensures that involved VAMC personnel receive clinical and administrative guidelines.

-          Completes grant applications/submissions.

-          Establishes and maintains standards of practice for the investigative research site.

-          Writes/assists in writing protocols for new research studies, informed consents, narratives and other reports as necessary.

-          Recruits potential new projects.

-          Researches medical information utilizing resources including the internet and library.

-          Inservices physicians, residents, faculty researchers and other VAMC and university personnel.

-          Utilizes nursing knowledge to assess patients and their health status.

-          Screens patients, evaluating their appropriateness for inclusion into clinical trials.

-          Ensures that protocol-specific procedures are completed as required.

-          Ensures accountability of research supplies, including trial medication and procedures.

-          Educates patients and hospitals personnel regarding protocol requirements.

-          Serves as liaison with sponsors; facilitates sponsor, clinical monitor and auditor site visits.

-          Presents abstracts at national meetings as required.

-          Performs other related duties as assigned.

Knowledge and Abilities

-       Knowledge of current, detailed regulations governing clinical research and quality assurance.

-       Knowledge of computer applications including spreadsheets, databases, computerized patient records and electronic transmission of files.

-       Knowledge of basic statistical design and analysis.

-       Knowledge of scientific principles and research methodology.

-       Knowledge of medical terminology, diseases/conditions under study, and Good Clinical Practices.

-       Ability to comprehend complex disease processes and their emerging treatment strategies.

-       Ability to perform multiple tasks in an emergency setting.

-       Ability to comprehend and disseminate information about complex clinical trials.

-       Ability to independently interpret medical charts.

-       Ability to independently assess patients and evaluate their eligibility for inclusion in specific protocols.

-       Ability to express information clearly, concisely and convincingly in different formats including formal protocols, reports and oral presentations.

-       Ability to exercise good judgment in evaluating medical and other situations and initiating appropriate decisions and interventions.

-       Ability to establish and maintain effective working relationships with patients, physicians, nurses and other personnel.

-       Ability to instruct patients in general patient education and application of specific study protocols.

-       Ability to relate to people in a wide variety of professional levels.

Supervision Given and Received

Performs under general supervision. Determines own methods of performing assigned work.

Minimum Qualifications

Registered Nurse with bachelor's degree required, master’s degree preferred; certification as CCRA or experience in clinical trials; five years in nursing to include clinical trial experience; current Tennessee RN license.

Date:  February 2008