Clinical Research Coordinator

Be You.

The Duke University Department of Dermatology is seeking a Clinical Research Coordinator.  This position will work on a mixture of Federal, Foundation, and Industry sponsored clinical trials, including investigator-initiated studies that are both single-site as well as multi-site with Duke being the coordinating center. Studies may be quite complex in nature and will benefit from an experienced coordinator. It will focus on sclerosing skin disorders including morphea, while also having the ability to work on any of the Dermatology Clinical Research Unit trials. Population will be largely adult, but there may be times where children are enrolled.

The ideal candidate for this role will be familiar both with Federal regulations and Duke policies and procedures. Understanding of multisite study workflows and basic regulatory principles is necessary.

Minimum Requirements:

Education/Training

Completion of an Associate's degree

Experience

Work requires a 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.

Be Bold.

Position Description:

Operations:

May train or oversee others in any of the areas below.

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.

Knowledgeable in regulatory and institutional policies and processes. Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (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). May train or oversee others. 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. Escalates issues.

Screens participants for greater than minimal risk or complex studies (e.g., procedural and interventional studies).

Develops or helps develop SOPs. May train or oversee others. 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.

Participates in study team meetings.

Ethics:

May train or oversee others in any of the areas below.

Identifies all Adverse Events (AE), and determines whether or not they are reportable. 

Collaborates with the Principal Investigator 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. May train or oversee others. 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. 

Data:

May train or oversee others in any of the areas below.

Enters and collects research data. Develops research data entry or collection tools.

May provide oversight or training to study team members collecting or entering research data.

Corrects and documents incomplete, inaccurate, or missing data for minimal risk studies according to predefined reports and queries. Follows standard operating procedures (SOPs) for quality assurance (QA).

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. With guidance, locates and follows repository-specific requirements to submit study data for 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.

Science:

Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies).

Demonstrates a basic understanding of the elements of research study designs.

Study and Site Management:

May train or oversee others in any of the areas below.

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.

May make feasibility recommendations. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. May train or oversee others. 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.

Leadership:

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.

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.

Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Choose Duke.

Join our award-winning team as identified by Forbes magazine as America’s Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work.

Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines.

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.