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.

Oncology Clinical Research Unit [CRU]

Bone Marrow Transplant, Hematology Malignancies & Cellular therapy Clinical Research Programs [BMT]

Clinical Research Coordinator [CRC], 

Position Description, 

Occupational Summary

Provide leadership and coordination in the conduct of multiple, complex oncology clinical trials and research studies 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] oversees the conduct of research. 

Work Preformed

Operations, Study and Site Management – 50% Effort

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. May train or oversee others. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others. Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others. Develops or helps develop SOPs. May train or oversee others. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others. Conducts activities for study visits in compliance with the protocol. May train staff. Participates in study team meetings.

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits. Uses required EMR functionalities to manage participants and study visits.  May train others. Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. May train others. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. May train or oversee others. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. Prepares studies for closeout and document storage. May train or oversee others.

Communication – 30% 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 – 5% Effort

Enters and collects data.  Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. With supervision, responds to queries created by a CRO or the data manager. May assists with quality control and data cleaning as directed. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance. Knowledgeable about the use of data standard policies. Performs de-identification on allowable data to Safe Harbor standards, or on consented data leaving Duke under agreements. Could serve as a Federated Honest Broker. May provide training to others. Innovatively uses technology to enhance a research process. May train others.

Leadership – 5% Effort

Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Ethics – 10% Effort

Identifies all AEs, and determines whether or not they are reportable.  Collaborates with the PI to determine AE attributes, including relatedness to study. May train or oversee others. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

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. 

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

The preferred candidate will have oncology or research experience, training, education or clinical trials coordination experience.   

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.

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