Senior Regulatory Affairs Coordinator

2 weeks ago

Durham, North Carolina, United States Duke University Full time
School of Medicine

Founded in 1930, Duke University School of Medicine stands as the youngest among the nation’s premier medical schools.

Ranked sixth nationally, the School is proud to foster an inclusive environment that nurtures exceptional learners, researchers, clinicians, and staff, promoting interdisciplinary collaboration to expedite the translation of groundbreaking scientific discoveries aimed at enhancing human health both locally and globally.

With a faculty of over 2,600 physicians and researchers, nearly 2,000 students, and more than 6,200 staff members, the Duke University School of Medicine, alongside the Duke University School of Nursing and Duke University Health System, forms Duke Health, a distinguished academic medical center.

The Health System includes Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, among various affiliations.

Occupational Summary


Oversee the daily regulatory and safety functions of a regulatory team engaged in multiple, intricate oncology clinical trials and research initiatives, including Investigational Products [IP] for the Duke Cancer Institute's [DCI] Bone Marrow Transplant Hematology Malignancies & Cellular Therapy Clinical Research Program [BMT].

The Oncology Clinical Research Unit [CRU] manages the execution of research.

Work Responsibilities

Operations, Study and Site Management - 40% Effort

Identifies when standard agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and notifies relevant parties. Acts as a knowledgeable resource for various study teams/research programs regarding regulatory and institutional policies and procedures. Participates in or leads the creation of monitoring and audit training sessions and/or policies and guidelines for the research program. Serves as a knowledgeable resource to address and rectify findings. Develops, supervises adherence to, and trains staff in the creation and application of SOPs across multiple study teams/research programs. Maintains comprehensive study-level documentation for all studies, including those of a complex nature (e.g., procedural and interventional studies). Provides oversight and training while lending expertise to multiple study teams. Prepares for and leads effective facilitation of research program meetings to achieve objectives. Ensures effective communication within the research program, including mentoring staff to enhance communication strategies.

Mentors, trains, and supervises activities related to team communications with sponsors and/or CROs. Oversees activities associated with site visits. Manages the use of systems and system reports to oversee research protocol activities and maintain current protocol information. Manages resources (staff, supplies, equipment) for multiple study teams/research programs. May oversee the budget for research studies. For multiple study teams, ensures compliance with institutional requirements and other policies. Manages the implementation of operational plans across various study teams or sites. Develops and executes closeout procedures for multiple studies across several teams.


Supervise the development and submission of documents such as consent forms, protocols, and continuing reviews to the Institutional Review Board [IRB].

Ensure the maintenance of study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.

Provide regulatory and safety reports.

Ensure study compliance with institutional requirements, protocols, and other applicable policies such as NIH Public Access policy and Research Data Security Plans.


Oversee the maintenance of Delegation of Authority Logs and the training of key personnel on study-specific duties.

Collaborate closely with study sponsors on regulatory and safety matters.

Prepare for study monitoring and audit visits. Address and rectify findings from study monitoring and audit visits.

Oversee the completion and submission of Adverse Events Reports, adhering to institution and sponsor-specific reporting requirements [timelines and forms].

Communication - 10% Effort

Collaborate and communicate with other study personnel and colleagues. Articulate concerns clearly and professionally. Respond promptly to inquiries and questions. Refer questions and escalate issues as appropriate.

Leadership - 40% Effort

Encourage staff participation in professional development opportunities. Stay informed about advancements in the scientific field and assess their impact on the research program. Keep self and team updated with research developments by attending external offerings; apply learned material on the job. Play a key/leadership role on committees and workgroups.

Navigates processes and personnel involved in Duke clinical research, demonstrating organizational awareness and possessing the interpersonal skills necessary for efficient work execution.

Develop and implement solutions that align with the existing leadership or organizational structure. Exhibit resilience and actively facilitate the research program through transitions.

Utilize advanced subject matter expertise in the therapeutic area or clinical research to resolve complex issues or promote innovation within the research program.

Communicate effectively with others, regardless of reporting relationships, to achieve shared work objectives.

Lead, supervise, and manage staff, including coaching, time-off, annual performance reviews, performance management, career development, training, hiring, and terminations. Model the DCI's core value "Cancer Care as It Should Be" for staff. Foster a team culture that promotes open communication, motivates staff, and encourages creativity. Seek out, listen to, accept, and act on feedback. Establish regular communication methods and meetings with staff; both collectively and individually. Be accessible to staff on a routine basis to provide leadership and mentoring.

Provide staff with clear, measurable goals, monitor performance and quality of work. Assign staff duties and responsibilities; cross-train and reassign as necessary to effectively conduct clinical research. Encourage and support the professional development of staff.

Oversee staff training and certifications to ensure compliance with standard operating procedures [SOPs], regulations, and protocol requirements governing clinical research.


Serve as an expert resource for colleagues and teammates. Support colleagues in their project work; encourage completion.

Ethics - 10% Effort

Provide oversight and training to multiple study teams/research program members involved in developing consent plans and documentation.

Act as an expert resource regarding the development of consent plans and documents for participants in various studies.

Provide oversight and training to multiple study teams/research program members who prepare and submit documentation and information for IRB review.

Provide oversight and training to multiple study teams/research program members who prepare and submit documents required for regulatory and safety reporting to sponsors and other agencies.


Summarize and clarify for study teams the professional guidelines and ethical standards related to regulatory and safety issues in clinical research.


Adhere to policies, standard operating procedures (SOPs), regulations, and protocol requirements governing clinical research. Maintain Duke and project-specific training and certification requirements.

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.


The intent of this job description is to represent the level and types of duties and responsibilities required for this position and shall not be construed as a declaration of the total specific duties and responsibilities.


Minimum Qualifications

Education

Completion of an Associate's degree

Experience

Work requires a minimum of six years of research and/or regulatory experience. A Bachelor's degree may substitute for 2 years of required experience.

Preferences

The preferred candidate will possess oncology or research experience, training, and education.

Job Code:
REGULATORY COORD, SR

Job Level: 53


Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunities 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 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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