Senior Regulatory Coordinator, Neurosurgery

Senior Regulatory Coordinator

Be You.

The Neurosurgery Clinical Research Unit (NSU CRU) at Duke is seeking a Senior Regulatory 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 six years of research experience. A bachelor's degree may substitute for 2 years required.
• 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, and research staff.

Preferred Qualifications:

• Regulatory research experience.
• Experience with Institutional Review Board (IRB) at Duke and external IRBs.
• Research-related education, training, or certification.
• Experience working with investigational products and complex clinical trials, collaborating with Duke Office of Regulatory Affairs and Quality (ORAQ), U.S. Food and Drug Administration (FDA), National Institute of Health (NIH), and other regulatory agencies.
• Experience with developing informed consents, protocols, supporting documents, and regulatory compliance activities.
• Ability to handle all regulatory requirements per study, i.e., Delegation of Authority (DOA) logs, training logs, approval letters, standard operating procedures (SOPs), adverse events (AE) reporting, budget and contract support.
• Familiarity with conducting internal monitoring according to the Duke Clinical Quality Management Program (CQMP) policy as well as preparation for external monitoring visits as well as study initiation visits and closeout visits.

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.
• 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 Senior Regulatory Coordinator, you will:

Oversee Complex Neurosurgery Clinical Trials

• Serve as an expert resource for Investigational New Drug (IND) submissions. Assists junior staff in addressing FDA reviews or issues. Provide oversight and guidance to those preparing documents, annual reports, and amendments required by the FDA.
• Provide directions to multiple study teams to prepare for study monitoring and audit visits.
• Collaborate closely with Principal Investigators, sponsors, and study teams to successfully conduct clinical research studies.

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, and required research files for all studies.
• 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).

Manage Research Data and Financial Activities

• Enter, review, and maintain accurate regulatory data in Electronic Data Capture systems, eReg systems, or other requested electronic systems.
• Identify and resolve discrepancies and documentation issues.
• Support study budget management, financial milestone tracking, and study closeout activities.
• Coordinate with financial teams to ensure timely processing of study startup agreements, study-related expenses, and billing reviews.
• Serve as a data corrections, queries, and QA expert resource within the Clinical Research Unit (CRU), department, or division; including liaising with and being knowledgeable about other related resources at Duke.

Safety, Ethics, and Scientific Concepts

• Ensure that multiple study teams are appropriately documenting AE information
• Provide oversight and training to multiple study teams who develop and submit documentation and information for IRB review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
• Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
• Independently, using scientific proposals from the PI, develop elements of research protocols for complex investigator-initiated studies, across multiple PIs or study teams.
• Use expertise in research design to make significant contributions to protocols or research proposals.
• Independently conducts literature searches or reviews and provides significant contribution or leadership on accepted, peer reviewed publications or conference presentations.

Provide Leadership and Collaboration

• Expert knowledge in regulatory and institutional policies and processes.
• Serve as a primary liaison between sponsors, investigators, research staff, and contract research organizations (CROs).
• Encourage staff to take part in professional development opportunities and provide opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.).
• Facilitate and lead meetings, committees, task forces, and departmental initiatives.
• Mentor colleagues and serve as a resource for research best practices.
• Pursue ongoing professional development.
• Train others to communicate effectively within teams and facilitate resolutions of issues associated with teams or communication.

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: 00001220 REGULATORY COORD, SR

Job Level: 53