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CLINICAL RESEARCH ASSOCIATE II
Job Title: CLINICAL RESEARCH ASSOCIATE II
Job Code: 1449
FLSA: E
Job Level: 81
Revised Date: 02/01/2016
Job Family: JF 05
Occupational Summary
Develop, coordinate, and implement monitoring administrative strategies essential to the successful management of clinical trials research conducted by principal investigators at the Duke University School of Medicine.
Work Performed
Participate in site selection and training site personnel regarding the trial; perform site routine monitoring of the trial and follow up to ensure identified deficiencies are corrected; travel as required inside and outside of the U.S.A.to accomplish responsibilities.
Coordinate the development of protocols, documentation and standard operating procedures for the administration and monitoring the clinical trials.
Follow established guidelines in the collection of clinical data and/or administration of clinical trials; assist in the determination guidelines for new protocols.
Coordinate the assessment of the suitability of potential investigative sites through telephone screening interviews, regulatory document review and disseminating clinical trial information; conduct site qualification visits to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of principal investigator to conduct and complete the planned clinical study.
Conduct site initiation visits for the purpose of training site personnel on the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, case report form completion and retention requirements, drug accountability procedures, serious adverse events (SAEs), reporting procedures and overall management.
Conduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and adherence to procedures through review of CRFs, source documents, medical records, and regulatory documents.
Provide feedback to assist sites which includes summary of overall site functioning and detected deficiencies and corrective action needed, follow up with sites until deficiencies are resolved.
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 two 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 four years healthcare experience; or
2.Completion of a master's degree in Public Health,., Health Administration or a related area with. one year directly related clinical trials research experience; or
3. Completion of a bachelor's degree plus a Minimum of two years directly related experience in clinical trials research; or
4. Completion of a bachelor's degree plus a minimum of three 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
N/A
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.
Duke University is an Affirmative Action/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, sex, sexual orientation, or veteran 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.
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.
