Lead Clinical Research Associate

Location
Durham, NC
Posted
Oct 03, 2017
Institution Type
Four-Year Institution

diversity employer



Lead Clinical Research Associate
DCRI - Site Support & Management

Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.

Position 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 responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOPs, applicable international, federal and state regulations, and ICH guidelines.

Primary Responsibilities and Tasks:
  • Provide leadership for the Clinical Operations project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work.
  • Manage the development and maintenance of clinical trials documents, processes, and systems according to trial-specific scope of work and 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.
  • 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).
  • 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 Lead for development of individual training plan.
  • Supervise and manage monitoring trial-team members' adherence to DCRI and sponsor-specific administrative policies with guidance.
  • Encourage team members to attend appropriate training and meetings.
  • Support the DCRI's mission, department goals and organizational activities.

Required Education and Experience: Bachelors degree in clinical, health or life science, with preferred training as Registered Nurse, Nurse Practitioner, Physician's Assistant, Pharmacist. 4-5 years related clinical research experience including 3 years directly related CRA experience or clinical trial management experience.

Requisition Number
401289272

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2985 CLINICAL RESEARCH ASSOCIATE, LEAD

Job Family Level
87

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 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

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.

Auto req ID

91680BR

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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