Clinical Research Coordinator

Be You.

The Neurosurgery Clinical Research Unit (NSU CRU) at Duke is seeking a Clinical Research Coordinator to join our team. In this role, you will help bring innovative neurosurgical, neurological, and spinal treatments and therapies to patients by coordinating complex clinical trials, some from bench to the bedside, conducting study startup through closeout.

You will play a key role in groundbreaking, first in human, brain/spine infusion drug and device studies from pediatric to adult subjects. If you are a motivated and talented research professional looking for the opportunity to get involved in a fast-paced, academic, medical, and scientific research environment, this is the place for you!

Minimum Requirements:

• Associate's degree.
• Minimum of two years of relevant clinical research experience.
• Completion of the DOCR North Carolina State Approved Clinical Research Apprenticeship Program may substitute for one year of required experience.
• Proficiency using Microsoft Office applications, web-based systems, and other research-related software applications.
• Ability to manage multiple studies and priorities simultaneously while maintaining attention to detail.
• Strong organizational, communication, and problem-solving skills.
• Ability to work collaboratively with investigators, sponsors, research staff, and participants.

Preferred Qualifications:

• Neurosurgery clinical research experience.
• Clinical trials coordination experience.
• Research-related education, training, or certification.
• Experience working with investigational products and complex clinical trials.
• Experience with participant recruitment, informed consent, and regulatory compliance activities.
• Familiarity with Electronic Data Capture (EDC) systems and clinical research documentation requirements.

Other Requirements:

• Basic Life Support (BLS) certification from the American Heart Association or Duke-approved equivalent course is required.
• Must maintain Duke and protocol-specific training and certification requirements.
• Ability to work effectively in a fast-paced clinical research environment.
• Availability to be on call for acute brain and spine trials with the established call team.
• Comfort interacting with patients, healthcare providers, sponsors, monitors, and regulatory personnel.

This position is:

• Hybrid eligible position (some days remote; some days on site).

Be Bold.

As a Clinical Research Coordinator, you will:

Coordinate Complex Neurosurgery Clinical Trials

• Recruit, screen, consent, enroll, schedule, and follow study participants in accordance with study protocols and regulatory requirements.
• Conduct and document participant visits, ensuring protocol adherence and participant safety.
• Collaborate closely with Principal Investigators, sponsors, and study teams to successfully conduct clinical research studies.
• Assist with site initiation, monitoring, and closeout activities.

Ensure Regulatory Compliance and Study Quality

• Recognize when agreements, such as CDAs, DUA/DTAs, and MTAs are needed and alert the appropriate parties.
• Maintain study documentation, regulatory binders, enrollment records, and required research files.
• Monitor protocol compliance and ensure adherence to institutional policies, federal regulations, and Good Clinical Practice guidelines.
• Document and report adverse events and protocol deviations in a timely manner.
• Support development of Conflict of Interest (COI), Data Safety Monitoring Plans (DSMPs), and Research Data Security Plans (RDSPs).

Support Participant Recruitment and Retention

• Implement recruitment and retention strategies to support study enrollment goals.
• Evaluate recruitment challenges and recommend solutions to improve participant engagement and retention.
• Assist participants with study-related needs and provide education regarding research participation.

Manage Research Data and Financial Activities

• Enter, review, and maintain accurate study data in Electronic Data Capture systems.
• Identify and resolve data discrepancies and documentation issues.
• Support study budget management, financial milestone tracking, participant reimbursements, and study closeout activities.
• Coordinate with financial teams to ensure timely processing of study startup agreements, study-related expenses, and billing reviews.

Safety and Ethics

• Identify all adverse events (AEs) and help determine if reportable by working with the PI.
• Collaborates with the PI to determine AE attributes, including relatedness to study.
• Conducts and documents consent for participants for all types of studies, including those that require any orders in Maestro Care.
• Develops consent plans and documents for participants in a variety of studies.
• Develops and submits documentation for IRB review in the Duke IRB system and in external IRB systems. Communicates with the IRB staff and reviewers and handles issues appropriately.
• Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.

Provide Leadership and Collaboration

• Knowledgeable in regulatory and institutional polices and processes.
• Serve as a primary liaison between sponsors, investigators, research staff, and study participants.
• Applies knowledge to assist with standard operating procedures (SOPs) for the CRU.
• Participate in team meetings, committees, task forces, and departmental initiatives.
• Mentor colleagues and serve as a resource for research best practices.
• Pursue ongoing professional development and contribute to scientific presentations and publications when appropriate.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Choose Duke.

Duke Neurosurgery provides world-class, patient centered care, research, and education with a commitment to excellence and innovating the treatments of tomorrow. We aspire to be a world leader in compassionate patient care, cutting-edge research, innovation, and education.

Trials involving research for Parkinson's Disease, Alzheimer's Disease, other movement disorders, rare genetic disorders, bleeding and/or tumors of the brain, epilepsy, brain/spine injuries, and chronic pain are just some of what our department loves to invest our time and effort towards. The Duke Neurosurgery research team is led by a productive group of clinically active neurosurgeons, neuro-oncologists, surgeon scientists, and dedicated PhD researchers.

We have a diverse research professional group that love working together as a team, are very supportive of one another, and have our own core team values.

Check us out at https://neurosurgery.duke.edu/

Job Code: 00001201 CLINICAL RESEARCH COORDINATOR

Job Level: 52

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $101,959.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

Equal Opportunity Employer: Duke is an 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 (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas 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 reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: DAAS@duke.edu; phone: 919-668-1267).

Screening of Applications (select one of the options below.)

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• Screening continues until position is filled. (Note: Search committee will screen applications as they come in and must continue screening ALL applications until position is filled, regardless of where the search committee is at in the review process.)
• For best consideration, apply by (date). (Note: Search committee will screen applications as they come in and will continue screening until specified date. Applications after the specified date will be considered a 2nd pool and cannot be reviewed until all applications before that date are deemed unqualified/unsuccessful.)