CLINICAL RESEARCH COORDINATOR

Duke Careers • Durham, NC

5d • Onsite

About The Position

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.Be You.

The Clinical Research Coordinator (CRC) will join a research team working on a study
led by investigators in the Duke Center for Aging. This position will directly support the Duke & UNC Alzheimer’s Disease Research Center’s commitment to fight Alzheimer’s Disease, with a focus on supporting the Memory and Aging Study. This will be an on-site position, and will require travel to off-site locations within the main Duke hospital campus.

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.

Requirements

• Completion of an Associate's degree
• 2 years relevant research experience or Bachelor’s degree

Nice To Haves

• Possess excellent verbal and written communication skills
• Possess human subject clinical research and regulatory experience
• Exhibit familiarity or ease communicating and relating to older adults, including those with cognitive impairment
• 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
• Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• May train or oversee others in the above tasks.
• Proactively seeks opportunities to add relevant skills related to work responsibilities.
• Keeps current with research updates by attending external offerings related to their work responsibilities (e.g., Research Wednesday, RPN, etc.) and applies the learned material to the job.
• May disseminate information to others.
• Uses advanced subject matter expertise in 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.
• Demonstrates resilience and is adaptive to change.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 101-250 employees