Duke University Job Descriptions

CLINICAL RESEARCH ASSOCIATE, LEAD

Job Title: CLINICAL RESEARCH ASSOCIATE, LEAD
Job Code: 2985
FLSA: E
Job Level: 78
Revised Date: 01/01/2018
Job Family: JF 05

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Occupational Summary

Manage the development, coordination, and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects with guidance, including trial-specific processes and systems, and daily supervision of the clinical operations team.

Work Performed

Responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOP's, applicable international, federal and state regulations and ICH guidelines. Half of the position responsibilities will involve providing leadership for functional group leaders for the execution of all monitoring services according to the project specific scope of work. Position will also budget with minimal guidance. Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance. Position will serve as key site management trial team member to internal and external partners and to the project core team (project leader, principal investigator, and other functional group key representatives.) Position will collaborate with clinical operations administration to identify and oversee trial related training and performance concerns of monitoring team members according to their individual needs; maintain awareness of level of performance and training needs; provide ongoing input to senior clinical trials leader for development of individual training plan.

Supervise and manage monitoring trial-team members' adherence to sponsor specific administrative policies with guidance. Encourage team members to attend appropriate training and meetings. Support the department mission, goals and organizational activities.

Position reports for a Project leader as a line manager and for daily activities. Position typically leads the monitoring team composed on clinical research associates I, II, and III and Senior Staff for all Clinical Trials activities through startup, enrollments, closeout and archiving.

Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Qualifications at this Level

Education/Training

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus four years of healthcare experience; or one of the following equivalents:

1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or

2.Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or

3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research;

or 4. Completion of a bachelor's degree plus a minimum of five years closely related research experience.

**State of North Carolina license may be required.**

Experience

None required beyond that described above

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills

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The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

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Duke University is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy related conditions), sexual orientation, or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

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Essential Physical Job Functions

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.