CLINICAL RESEARCH ASSOCIATE

Updated: about 4 hours ago
Location: Durham, NORTH CAROLINA

JOB SUMMARY

The Duke Cancer Network (DCN) Clinical Research Associate (CRA) develops, coordinates, and implements monitoring and compliance strategies essential to the successful management and oversight of clinical research conducted by Investigators at the Duke University School of Medicine, Duke University Health System, and Affiliates. This position reports directly to the Director of Clinical Research for the DCN.

WORK PERFORMED

Develop and maintain an understanding of oncology clinical research, maintain extensive knowledge of university policies, local, state and federal regulations; Food and Drug Administration (FDA), Department of Health and Human Services (DHHS), Health Insurance Portability and Accountability Act (HIPAA); National Institute of Health (NIH) research requirements; and the ethical standards that govern the conduct of human subjects research such as Good Clinical Practices (GCP).

Perform routine monitoring of research to ensure protocol and regulatory compliance, data integrity, and protection of human research subjects; develop and disseminate monitoring reports, provide guidance on required corrective actions and ensure identified deficiencies are corrected. Coordinate and prepare investigators and study staff for external quality assurance and regulatory audits; assist with the development and implementation of corrective action plans. 

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 protocol management. Monitor ongoing research activities to ensure timely reporting and review of data, subject enrollment, SAEs, and protocol deviations.

Conduct site qualification assessments to determine adequacy of the facilities and available resources to comply with regulatory and protocol requirements; assess overall interest, commitment, and adequacy of training and education of the principal investigator and study team to manage the research.

Perform affiliate site IRB assessments and provide recommendations for improvement of the Human Research Protection Program.

Provide input on operational activities related to the conduct of clinical research; assist in internal quality assurance reviews and participate in implementing quality improvement activities; identify opportunities for increased efficiency and operational excellence.

Develop, implement, disseminate, and maintain policies, procedures, templates, and tools supporting research compliance initiatives related to Good Clinical Practices, Federal Regulations, HIPAA, and the ethical conduct of human subject research. Assist with site policy assessments, identify deficiencies, and provide guidance and recommendations for improvement and alignment with regulations and best practices.

Identify training and educational needs regarding clinical research and protocol compliance; assist with the development and implementation of the research education program, protocol specific education, and conduct training and mentoring of investigators and staff.  Disseminate educational materials, regulation and policy updates; may include but is not limited to clinical trial information, protocol compliance initiatives, and Good Clinical Practices.

Collect and analyze data to support the DCN research annual quality improvement plan, assist with performing institutional risk assessments and gap analysis. Identify, develop, and implement quality improvement initiatives. Prepare reports and presentations for leadership and research teams supporting the DCN strategic plan.

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. This position has the opportunity for remote work; travel may be required to accomplish responsibilities.

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), Nurse Practitioner (NP), or Pharmacist plus three 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 two years directly related clinical trials research experience; or

3. 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


Duke 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 essentialjob 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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