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.

Occupational Summary:

The Clinical Research Coordinator (CRC) will join a growing research team working on studies led by investigators in the Duke Center for Aging. Studies will focus on neurocognition and health disparities, with a focus in the Hispanic/Latino population. Proficiency in oral and written Spanish and English is required. This will be an on-site position, and may require travel to off-site locations. Candidates must have a valid NC driver’s license or be eligible to obtain a NC driver’s license before the start of the position, and must have a reliable, insured vehicle and be willing to drive it for research-related tasks.

Preferred Skills:

The ideal candidate will:

• Possess excellent verbal and written communication skills in both Spanish and English
• Possess human subject clinical research and regulatory experience
• Exhibit familiarity or ease communicating and relating to older adults
• Possess effective recruitment and retention skills
• Demonstrate the ability to plan and prioritize workload to meet deadlines
• Be willing to be flexible in order to accomplish the shared goals of projects
• Demonstrate flexibility and willingness to acquire new skills
• Showcase their proven ability to work both independently and within a team with excellence, dignity, and respect

Work Performed:

The clinical research coordinator will participate in or lead day to day operations of clinical research studies conducted by principal investigator(s) at Duke Health; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks.

Research Operations. (35%)

• Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs).
• Screen participants for complex studies (e.g., procedural and interventional studies).
• Develops or helps develop SOPs.
• Employs and may develop strategies to maintain recruitment and retention rates and evaluate processes to identify problems.
• Escalates issues as needed.
• Conducts and plans for study visits.
• Maintains participant level and study level documentation for all studies.
• Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
• Addresses and corrects findings.
• Serves as the primary liaison with sponsors and other parties as necessary.
• Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
• Leads meetings that are multidisciplinary, including those with complex objectives.

Safety and Ethics. (5%)

• Conducts and documents consent for participants for studies. 
• Develops consent plans and documents for participants in a variety of studies.
• Develops and submits documentation and information for Institutional Review Board (IRB) review.
• Communicates with the IRB staff and reviewers and handle issues appropriately. Identifies all adverse events (AEs), and determines whether or not they are reportable.
• Collaborates with the PI to determine AE attributes, including relatedness to study.
• Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
• Responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations.
• Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation.

Data. (20%)

• Enters and collects data, and 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.
• Recognizes data quality trends and escalates as appropriate.
• May develop tools for, and train others in, data quality assurance procedures.
• Recognizes and reports security of physical and electronic data vulnerabilities.
• May develop or review research data security plans (RDSPs) for multiple study protocols.
• Maps a protocols data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).
• Independently uses and implements technology to enhance productivity or process.

Scientific Concepts. (5%)

• Assists with or contributes to the development of funding proposals. Using scientific proposals from the PI, develops research protocols.
• Demonstrates a basic understanding of the elements of research study designs.
• Independently conducts literature searches and reviews. Contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications.

Site and Study Management. (25%)

• Collects appropriate information to determine whether the study teams participation in a specific trial is feasible.
• May make feasibility recommendations.
• Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows, and may develop or implement, protocol specific systems and documents including process flows.
• Prepares for, coordinates, and actively participates in site visits.
• Communicates effectively with sponsors and/or contract research organizations (CROs).
• Uses systems and system reports to manage research participants activities and charge routing.
• Prepares studies for closeout and document storage.

Leadership and professionalism. (10%)

• May train or oversee others in the above tasks. Proactively seeks opportunities to add relevant skills and certifications to own portfolio.
• 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.
• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.
• Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
• May serve on committees and workgroups internal to Duke or externally in therapeutic area of research.
• Demonstrates resilience and is adaptive to change.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Required Qualifications at this Level

Job Code: 00001201 CLINICAL RESEARCH COORDINATOR
Job Level: 52

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 jobsat 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.