Clinical Research Coordinator (Durham, NC, US, 27710)

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses 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, and multiple affiliations.

Be You.

Provide leadership and coordination in the conduct of research studies focused on cancer patients’ experiences and palliative care research for the Duke Cancer Institute’s [DCI] Cancer Patient Experience Research Program [CPEP].  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. CPEP primarily focuses on research pertaining to cancer patients’ experiences and palliative care research. The research performed is both original and sponsored, utilizing quantitative, qualitative, or mixed-methods.

Contributes to study design conversations both individually and as part of the team.  The work includes data collection and documentation of cancer patient experience studies, including patient reported outcome (PRO), real-world evidence (RWE) studies, Quality of Life (QoL) intervention, and retrospective studies, patient screening, recruitment, consent, data collection, and study participant interactions and contact.

 

Minimum Qualifications

Education

Completion of an Associate's degree

 

Experience

Work requires a minimum of two years of relevant research experience. Completionof the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience.

 

Preferences

The preferred candidate will have a master’s degree and experience with REDCap and EPIC.

1. Advanced Microsoft Excel skills
2. Experience with surveys and interviews in clinical research
3. Experience with data capture forms
4. Experience in oncology or palliative care or regulatory
5. Experience with Patient Reported Outcomes, Real World Evidence, and/or Biobehavioral studies is a plus
6. Experience with other electronic medical records [EMR] and OnCore

 

Be Bold

Work Preformed

Operations, Study and Site Management – 55% Effort

This hybrid position will require the individual to employ strategies to maintain recruitment and retention rates, and assist participants with individual needs.  Collect information to determine appropriate study feasibility, recruitment and retention strategies.  Evaluate processes to identify issues related to recruitment and retention rates; offer solutions. 

Work closely with the Principal Investigator [PI] and study team to recruit, screen and enroll participants for studies.  Conduct and document consent for study participants.  Schedule participants and conduct visits for studies; conduct and document visits. 

Coordinate study activities with teammates and colleagues to successfully implement and conduct the study.  Recognize and offer solutions to study problems. Escalate issues appropriately.  Take part in site initiation and closeout visits.  Assist in the development of new studies.

Maintain study's compliance with institutional requirements and policies.  Maintain appropriate study-level documentation including regulatory binders, enrollment logs, and patient registration in the system of record.  Record adverse events [AE] and report promptly.  Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.     

Assist with the development of Conflict of Interest [COI], Data Safety Monitoring Plans [DSMPs], and Research Data Security Plans [RDSPs].  Assist with the coordination of external monitoring boards.

Follow procedures and documentation of study payment and participant care expenses in a timely fashion.  Monitor financial study milestones and report appropriately.  Coordinate with financial teams and participate in budget development.  Assist with study budgets and closeouts. 

Communication – 10% Effort

Serve as primary liaison with sponsors, study personnel and PI for assigned studies.  Collaborate, and communicate with other study personnel as required.  Communicate concerns clearly in a professional manner.  Respond timely to emails, phone calls and questions.  Refer more complex questions and escalate issues to others as appropriate.  

Data – 25% Effort

Use Electronic Data Capture [EDC] systems and enter data accurately.  Detect issues related to data capture, collection or management and suggest solutions. 

Comply with required processes, policies, and systems to ensure data security and provenance.  Recognize and report vulnerabilities related to security of physical and electronic data.  Assist in investigating incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data. 

Leadership – 5% Effort

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

Provide staff with clear measureable goals, monitor performance and quality of work.    Assign staff duties and responsibilities; cross-train and reassign as needed to effectively conduct clinical research.  Foster and encourage the professional development of staff.  Oversee staff training and certifications to ensure compliance with standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research. 

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

Ethics – 5% Effort

Understand the difference between clinical trials and clinical research, and be able to demonstrate and articulate the differences in regulations that must be adhered to, as well as the differences in processes internal to Duke.

Communicate to study staff and research participants the difference between clinical and research activities, and the risks and benefits of study participations.  Recognize when staff and patients are having difficulty with the distinction and work hard to help them understand the differences. 

Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. 

Know and follow policies, standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research.  Maintain Duke and project specific training and certification requirements.

Basic Life Saving [BLS] certification from the American Heart Association or Duke approved equivalent course is a requirement of this position. 

Other work as assigned. 

Skills

Excellent interpersonal and communication skills.  Comfortable discussing difficult topics such as end-of-life planning.  Ability to work successfully on multidisciplinary teams.

Highly organized with a strong attention to detail.  Ability to prioritize multiple tasks with competing deadlines. 

Skills

1. Proficiency with Microsoft Excel, Word, and Outlook is required.
2. Ability to manage multiple competing priorities effectively.
3. Excellent organizational skills
4. Excellent verbal and written communication skills
5. Ability to easily use computer software, web-based applications and learn new systems.
6. Flexibility to solve problems and accomplish project goals.
7. Ability to work independently and within a team with excellence, dignity and respect.

 

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

 

Choose Duke.

Join our award-winning team as identified by Forbes magazine as America’s Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work.

 

Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines.

 

Beyond the engaging work, you'll also benefit from Duke's competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.