Clinical Research Coordinator -DCN Research Administration

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The Duke Cancer Network (DCN) is looking for a clinical research regulatory coordinator to assist with the daily management, compliance, and oversight of multiple complex oncology clinical trials conducted at Duke Community affiliate sites.  The ideal candidate should have experience in clinical research regulatory processes across multiple sites, different therapeutic areas, and study phases. This individual should have a strong understanding of human subjects research regulations, Standard Operating Procedures (SOP’s), good clinical practices, and oncology clinical trials.

The ideal candidate will demonstrate good interpersonal communication skills and business etiquette, interest in participating in program development, education, and quality improvement projects to support DCN affiliates. This individual should be detailed oriented, organized, have the ability to multi-task, and prioritize work independently.  This position is conducted primarily remotely with approximately 10% local travel as needed.

JOB RESPONSIBILITIES

The following description of job responsibilities and standards reflects the major duties of the job, but does not describe minor duties or other responsibilities that are assigned from time to time.

Research Regulatory Operations:

• Assist in the coordination of the regulatory aspects of multi-site, large-scale oncology clinical trials conducted by cooperative groups, Duke Investigators, pharmaceutical companies or other sponsors. Ensure timely submission and implementation of new studies, annual reviews, and amendments. 
• Maintain clinical trial databases for the DCN research portfolio; track and maintain appropriate documentation for studies that are pending, open, closed to accrual, and closed to regulatory.  Assist in the development and maintenance of protocol and site status reports.
• Prepare documents for Protocol Review and Monitoring Committee (PRMC) and the Institutional Review Board (IRB) submissions. Develop consent forms that comply with federal and local requirements.
• Assist with regulatory audits and routine monitoring visits. Assure compliance with institutional standards, good clinical practices, and human subjects research protections.
• Assist with the onboarding of research staff and new affiliate sites; including training and education for good clinical practice and protocol specific requirements, provide guidance on regulatory research requirements.
• Collect and maintain all required site-specific essential documents, certificate of insurance, lab certificates, staff training and education documentation.
• Prepare initial submission materials for affiliate site local review and approval. This includes Clinical Research Collaboration Agreements and Individual Protocol Agreements.
• Prepare, submit, and ensure review of documents to sites for new protocols, amendments, and continuing reviews. Maintain IRB records for each protocol including initial approval, amendments, annual reviews, serious adverse event reports, consent form, and other regulatory correspondence in accordance with FDA, sponsor and ICH guidelines. 

Work Culture & Professional Development:

• Attend educational workshops and seminars as able to maintain current knowledge of federal regulations, compliance standards, and institutional requirements.
• Participate in site, protocol-specific, and disease group meetings as necessary.
• Maintain positive relationships with all parties involved in the functioning of Duke-affiliated programs, including, but not limited to institutional officials, staff and physicians of the Duke Cancer Network, Duke Cancer Institute, affiliate site administrative and clinical staff.

Customer Service:

• Serve as a resource for questions and problems related to clinical research regulatory and compliance for DCN staff  as well as the DCN affiliate sites.
• Assist study monitors as needed during site visits with regulatory document reviews.
• Serve as the primary contact for CROs and/or Sponsors for all regulatory and compliance issues.
• Serve as the primary contact for the Duke IRB, the regulatory coordinators at Duke, the Human Protections Administrators or Regulatory Managers, and the Local Research Review Committees/IRBs at DCN sites.
• Collaborate with Duke clinical research staff for educational and study operations.

Education 

Work requires graduation from an accredited degree program in a Clinical Research Field such as a Bachelor's in Clinical Research, plus two years of healthcare experience in the clinical research setting, or the  following equivalent: 

Completion of an applied science degree (e.g. Clinical Trials Research) or an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) plus a minimum of five years clinical research experience

Certification in Clinical Research is strongly recommended (SOCRA).

Experience in the area of regulatory compliance

PHYSICAL AND MENTAL REQUIREMENTS

• Ability to travel to affiliated sites
• Exposure to hazardous waste and infectious materials
• Physical abilities to complete job duties under prescribed environmental and working conditions
• Personal stressors should not affect the ability to perform job duties
• Ability to effectively assess research-related issues with DCN affiliate sites and internal teams and collaborate to resolve
• Ability to effectively convey an expectation of compliance and hold teams/individuals accountable, while maintaining a climate of mutual collaboration and respect

EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

• Knowledge/experience in clinical research
• Knowledge/experience with local IRB submissions
• Knowledge of HHS and FDA human protection regulations
• Excellent organizational and verbal and written communication skills
• Proficiency with computer software including word processing and databases

• Human subjects research protections 
• Clinical research operations
• Data Management

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.