CLINICAL RESEARCH COORDINATOR

About the role

The School of Medicine at Duke University is seeking a dedicated individual to join our team. As a member of the Operations Screen team, you will play a crucial role in ensuring the smooth operation of our research studies.

Responsibilities

• Independently screen participants and provide oversight and training to study team members who screen participants.
• Maintain subject level documentation for all studies independently.
• Oversee and train study team members who maintain subject level documentation, including documentation in the EMR.
• Schedule participants and conduct visits for all studies independently.
• Train others to conduct and document visits and protocol-specific testing/interviews.
• Assist with development and follow procedures and documentation of study payment in timely fashion.
• Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
• Afford the required system for handling, dispensing and documentation of IP for sponsored protocols.
• May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary.
• Maintain appropriate documentation.
• Track IP compliance at the protocol-and subject level.
• Train staff to maintain exemplary documentation including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc.
• Oversee maintenance of subject level documentation.
• Implement innovative solutions to maximize recruitment and retention.
• Oversee the collection of adverse event information.
• Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently and train other staff in these tasks.
• Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
• Train others on study team in use of technologies and software, and in completion of ECRFs.
• Assist with the development of data collection documents to standardize process.
• Use EDC systems and enter data accurately.
• Use required processes, policies, and systems to ensure data security and provenance.
• Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.
• Run summaries and reports on existing data.
• Follow SOPs for data QA.
• Recognize when data agreements are necessary.
• Assign, review, and train others in various work responsibilities.
• Serve as a mentor to junior staff, including others with my title.
• Employ escalation and performance plans as needed.
• Lead study teams with regard to clinical research professional guidelines and code of ethics.
• Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research.
• Make recommendations to investigative team.
• Determine and implement alternative solutions to accomplish recruitment and retention milestones.
• Ensure participant care expenses have appropriate financial routing in a timely manner.
• Monitor financial study milestones and report appropriately.
• Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate.
• Absorb and train others in the use of system reports to ensure unit, division, or department compliance with institutional requirement/policies; assist team members with understanding these requirements and policies.
• Oversee study teams' maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
• Work with sponsors and study teams to arrange required sponsor training.
• Provide feedback to the study team members; and serve as an institutional resource to the study visitors.
• Take part in or lead closeout and document storage activities.
• Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.

Qualifications

• Completion of an Associate's degree.
• Minimum of two years of relevant research experience.
• Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience.

Skills

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

Benefits

Choose Duke Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $59,829.00 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/

Equal Opportunity Employer

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.