CLINICAL TRIALS COORDINATOR II, DCRI - Pragmatic-HSR

Location
Durham, NC
Posted
Apr 22, 2017
Institution Type
Four-Year Institution

CLINICAL TRIALS COORDINATOR II, DCRI - Pragmatic-HSR
Pragmatic-HSR


OCCUPATIONAL SUMMARY:

Develop, coordinate and implement research and administrative strategies essential to the successful management of pragmatic health systems research conducted by principal investigator(s) at Duke University Medical Center or within sponsored research networks; perform a variety of duties involved in the organization, oversight, documentation and compilation of health systems research data





WORK PERFORMED

Coordinate assigned health systems or services research studies conducted by a supervising principal investigator(s) or network in support of activities that meet objectives of assigned research protocol(s) and/or network.



Follow established guidelines in the collection of clinical data and/or administration of research projects; assist in the determination of guidelines for new protocols. Gather, monitor and submit IRB documentation. Assess and compile Data Use Agreements.



Confer with site or network personnel, including coordinators, physicians and project managers, to explain protocol and to elicit compliance with regulations and agreements; assure adherence to FDA, protocol, and/or network guidelines; identify potential problems and/or inconsistencies and take action as appropriate.



Draft a variety of reports, documents and correspondence for regulatory agencies, participating project sites, and network collaborators and for internal purposes to assist in the ongoing monitoring and evaluation of the project's progress. Track network participation metrics such as studies participation, master contract, data sharing agreements, and IRB approvals. Coordinate network activities in support of network goals.



Assist principal investigator(s) and/or other members of the research team in the development of plans and protocols for clinical research studies; contribute to the ongoing analysis and modification of protocols as appropriate.



Prepare and recommend amendments to research protocol(s) in conjunction with appropriate committees. Ensure distribution of appropriate forms and supplies, required for execution of research protocol(s) and/or network objective; oversee clinical trials assistant and/or contracting agents in the receipt and dissemination of study and network materials. Supervise work of clinical trials assistants within designated areas and assist in training new personnel; inspect study files to ensure completeness and accuracy of data.


Requisition Number
401221621

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1944 CLINICAL TRIALS COORDINATOR II

Job Family Level
80

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications


Education

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN). Physician's Assistant (PA) or Pharmacists plus a minimum of two years 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 a minimum of one year directly related clinical trials research experience; or
3. Completion of a Bachelor's degree plus a minimum of two years directly related 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 licensure may be required**

Experience

None required beyond that described above.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

Auto req ID

86705BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

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