Clinical Research Coordinator

Duke Careers • Durham, NC

2d • 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.
Clinical responsibilities: •
Type of Research:This full-time, onsite Clinical Research Professional (CRP) will support research initiatives enrolling adult pulmonary participants, led by Principal Investigators (PIs) within Duke's School of Medicine Clinical Research Unit (CRU), Division of Pulmonary Medicine. Reporting directly to the Critical Care Research Program Leader (RPL), the CRP will play a key role in the execution of clinical research studies, ensuring compliance with institutional, regulatory, and sponsor guidelines. The CRP will actively engage with community stakeholders to support participant recruitment and retention efforts. Responsibilities include electronic medical record (EMR) review, participant screening, travel to offsite investigators' meetings as needed, conducting informed consent, facilitating enrollment, and leading study visits in clinical settings. The CRP will also manage specimen collection, processing, and documentation; oversee investigational product (IP) accountability; and ensure accurate data collection, entry, and query resolution in electronic databases. Additional duties include preparing and maintaining study documentation, coordinating IRB and regulatory submissions, and processing participant payments. The CRP will support a diverse portfolio of studies, including industry-sponsored, federally funded, foundation-supported, and investigator-initiated trials. This role may also involve supervising the work of junior staff and providing mentorship and training in clinical research procedures. While the RPL will serve as the CRP's direct supervisor, the Principal Investigators will provide scientific oversight, mentorship, and guidance in the conduct of research activities.

Nice To Haves

• Preference in research and/or patient care.

Responsibilities

• 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.
• 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.
• Maintains all participant level documentation for studies that are greater than minimal risk or complex in nature (e.g., procedural and interventional studies).
• Employs strategies to maintain retention rates.
• Evaluates processes to identify problems with retention.
• Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems.
• Screens participants for greater than minimal risk or complex studies (e.g., procedural and interventional studies).
• Develops or helps develop 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.
• Contributes to the effective facilitation of team meetings to achieve predetermined objectives.
• 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 greater than minimal risk or complex in nature and/or require any orders in Maestro Care.
• Develops consent plans and documents for participants in a variety of studies.
• Develops and submits documentation for IRB review in iRIS.
• Communicates with the IRB staff and reviewers and handles issues appropriately.
• Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
• Enters and collects research data.
• Develops research data entry or collection tools.
• Ensures accuracy and completeness of data for all studies, including those that are greater than minimal risk or complex in nature.
• Recognizes data quality trends and escalates as appropriate.
• Follows required processes, policies, and systems to ensure data security and provenance.
• Follows requirements for depositing data into an appropriate repository and meta-data specifications for data sharing.
• Maps a protocol's data workflow including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).
• Innovatively uses technology to enhance a research process.
• Prepares tables, data visualizations, and lay summaries to communicate study results to participants.
• Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators.
• Independently conducts literature searches and reviews.
• Develops elements of research protocols using scientific proposals from the PI.
• Demonstrates a basic understanding of the elements of research study designs.
• Contributes to the development of scientific publications or presentations.
• Serves as an author on poster presentations or publications.
• 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 of financial milestones, and all aspects of study visits.
• Uses required EHR functionalities to manage participants and study visits.
• Uses OnCore and eREG systems and system reports to manage research protocols.
• Collects appropriate information to determine whether the study team's participation in a specific trial is feasible.
• For studies with 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, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows).
• Prepares studies for closeout and document storage.
• 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.
• Serves on committees and workgroups internal to Duke or externally in therapeutic area of research.
• Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
• Develops and implements solutions that work within the existing leadership or organizational structure.
• 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.

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: Entry Level
• Education Level: No Education Listed
• Number of Employees: 101-250 employees