CLINICAL RESEARCH COORDINATOR

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.

The Department of Dermatology is looking for a Clinical Research Coordinator to join our team. This on-site position will be an integral part of all industry clinical trials, and any prospectively enrolling Principal Investigator initiated studies for the Department of Dermatology. These trials will mostly be investigational drug trials of all phases, but there are also device trials that may occur. The population will generally be adults, but sometimes trials will enroll ages 12 and up.

Minimum Requirements:

Experience with drawing blood or the willingness to learn is required. Flexibility in work locations on site as we have 2 clinical sites.

Education/Training

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.

Be Bold.

Position Description:

Operations:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.

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.

Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary.

Follows protocol schema for randomization and blinding/unblinding.

Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. 

Maintain all participant level documentation for studies that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. 

Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants for complex studies (e.g., procedural and interventional studies).

Follows SOPs. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures.

Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).

Conducts activities for study visits in compliance with the protocol. Participates in study team meetings.

Ethics:
Identifies all Adverse Events, and determines whether or not they are reportable. 

Collaborates with the PI to determine AE attributes, including relatedness to study.

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. 

Assists with the development of consent plans and documents for participants.

Data:
Enters and collects basic data for research studies. May score scripted or validated tests and measures. Under supervision, corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Follows required processes, policies, and systems to ensure data security and provenance. Learns and uses new technology when required.

Science:
Demonstrates a basic understanding of the elements of research study designs.

Study and Site Management:
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. 

Uses OnCore and eREG systems and system reports to manage research protocols.

For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.

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.

Leadership:
Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.).

Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.

Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Choose Duke.

Join our award-winning team and be part of an inclusive culture that values excellence, innovation, and discovery. 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.

Screening of Applications: Screening continues until the position is filled.

Anticipated Pay Range:

Duke University provides an annual base salary range for this position as USD $59,829 to USD $99,960.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate 's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at https://hr.duke.edu/benefits/

Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends onthe 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.