Clinical Research Coordinator, Duke Cancer Institute

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.

Clinical Research Coordinator  (CRC)

Oncology Clinical Research Unit [CRU]

Cancer Patient Experience Research Program [CPEP]

Position Description

Occupational Summary

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-method. The majority of the studies are minimal risk.

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) and real-world evidence (RWE) studies, patient screening, recruitment, consent, data collection, and study participant interactions and contact.

Each team member is expected to work independently, but also assist one another when needed.  The team encourages the sharing of ideas and expertise, and fosters an environment that is centered on the research patients, as well as the integrity and science of the research.  Individuals that are team-oriented, yet who regularly and independently seek ways to increase their research abilities, and who are open to learning new electronic systems are encouraged to apply.

Work Preformed

Operations, Study and Site Management – 55% Effort

This hybrid position will require the individual to employ and develop research strategies for screening and recruitment, maintain recruitment and retention rates, and assist participants with individual needs.  Collect information to determine appropriate study feasibility, recruitment and retention strategies.  Develop consenting plans.  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.  Develop resources and tools for the management of assigned 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.  Develop and submit documentation and information to the Institutional Review Board (IRB).  

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.  Manage participant payments.  Monitor financial study milestones and report appropriately.  Coordinate with financial teams and participate in budget development.  Assist with study budgets and closeouts. 

Data – 25% Effort

Use Electronic Data Capture [EDC] systems and enter data accurately.  Ensure accuracy and completeness of data for all studies.  Develop data collection and capture tools.  Assist with the design of and administer electronic surveys and questionnaires.  Independently utilize and implement technology to enhance productivity and processes.

Develop and review Research Data Security Plans (RDSPs) for assigned study protocols.         

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.  Detect issues related to data capture, collection or management and suggest solutions. 

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.  

Assist with literature searches and reviews.  Contribute to the development of research protocol sections, as assigned.  Contribute to scientific publications or presentations, as requested.

Leadership – 5% Effort

Actively network.  Provide leadership within the team.  Actively and proactively participate in team meetings, committees, task forces and ad hoc groups.  Lead meetings as assigned.  Train others regarding assigned protocol tasks.

Encourage career development by actively seeking out continuing education opportunities.  Participate in scientific presentations and publications. 

Serve as an expert resource for colleagues and teammates.  Mentor staff, including those in the same job title.  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.

Other work as assigned. 

Skills

1. Self-starter
2. Proficiency with Microsoft Excel, Word, and Outlook required  
3. Ability to manage multiple competing priorities effectively
4. Excellent organizational skills
5. Excellent verbal and written communication skills
6. Ability to easily use computer software, web-based applications, and learn new systems
7. Flexibility to solve problems and accomplish project goals
8. Ability to work independently, as well as within a team with excellence, dignity and respect
9. Ability to talk comfortably over the phone with patients
10. Ability to effectively work remotely with a hybrid schedule

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

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.

Preferences

1. Advanced Microsoft Excel skills
2. Experience with surveys and interviews in clinical research
3. REDCap experience
4. Experience with data capture forms
5. Bachelor’s degree
6. Experience in oncology or palliative care or regulatory
7. Experience with Patient Reported Outcomes, Real World Evidence, and Biobehavioral studies
8. Experience with electronic medical records [EMR], Advarra OnCore, and eREG

Qualifications Required At This Level

Link to the required education, training, experience and skills required for a 1201 Clinical Research Coordinator classification: https://forms.hr.duke.edu/descriptions/university/select.php?ID=1201  

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

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.