CLINICAL RESEARCH COORDINATOR

This Position is grant funded

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 Duke Center for Precision Health is looking for a Clinical Research Coordinator to join our group. You will be part of a team working on OneDukeGen, a large multidisciplinary research study aimed at better understanding how genes affect health. The ultimate goal is to enable more personalized healthcare.

You will be recruiting and enrolling Duke patients, and working with various clinics throughout Duke Health. Tasks will include consenting, sample collection, sample processing, documentation, and collaborating with other team members.

This position is fully grant funded.

Minimum Requirements:

• Completion of an Associate's degree
• Minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

• Experience performing phlebotomy is required.

• Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Preferred Qualifications:

• Fluency in Spanish is preferred but not required.

Other Requirements:

• This position is onsite. The work is performed onsite or at a designated assignment location.

• This position will involve walking between clinics and campus locations, processing samples, and flexible working hours (early start or late stop).

Be Bold.

Position Description:

• Operations:

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. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. 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. Follows SOPs and strategies to manage and retain research subjects. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Develops or helps develop SOPs. 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. Participates in study team meetings.

• Ethics:

Identifies all AEs, 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. May train or oversee others. Assists with the development of consent plans and documents for participants.

• Data:

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. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Follows required processes, policies, and systems to ensure data security and provenance. In addition, recognizes and reports security of physical and electronic data vulnerabilities. Learns and uses new technology when required. Assists in updating reports on study progress for the PI and other study team members and collaborators.

• Science:

Assists with simple literature searches. Demonstrates a basic understanding of the elements of research study designs.

• Study and site management:

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. Records basic protocol information in clinical research management system. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

• Leadership:

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.

Choose Duke.

The Duke Clinical & Translational Science Institute is the home for the Duke Center for Precision Health. The Center is a nexus of human genomic and biomarker discovery, population genomics, genomics ethics and implementation science, all in support of precision health and integrating the Duke School of Medicine with the Duke Health System. 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 $58,656.00 to USD $98,000.00. 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/