Clinical Research Coordinator, Arringdon Orthopaedic Surgery

School of Medicine

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CLINICAL RESEARCH COORDINATOR, Arringdon Orthopaedic Surgery

Operations: 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. May train others in these policies and processes. Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.

Addresses and corrects findings. May train others. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR.

Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. May train or oversee others.

Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others.

Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.

Assists with establishing and maintaining study level documentation. Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc.

Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. Participates in study team meetings.

Ethics: Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. May train or oversee others.

Conducts an d documents consent for participants in non-complex studies. These are typically repositories, survey studies, simple observational studies and no n-patient studies that do not involve investigational products or devices. Cannot consent for any studies that involve investigational products or devices or require clinical research orders in Maestro Care (i.e., electronic health record). Assists with the development of consent plans and documents for participants.

Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. May train or oversee others.

Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others. Data: Enters and collects data.

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, including those that are complex in nature.

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 RDSPs for multiple study protocols. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, an d preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others. Learns and uses new technology when required. Science: Under guidance, develops section s of protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs . Study and Site Management:

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs.

Records participant accrual information and con sent documentation for non-complex studies in clinical research management system. Records basic protocol information in clinical research management system. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible.

May make recommendations. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Ensure s that studies are conducted in compliance with institutional requirement and other policies.

Follows, and may develop or implement, protocol-specific systems and documents including process flows. May train or oversee others.

Prepares studies for closeout and document storage.

May train or oversee others. Leadership: Maintains Duke and project specific training requirements. 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. 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. Type of Research:

This project is examining Biopsychosocial Influence on Shoulder Pain: Total Shoulder Arthroplasty. The coordinators role will require collection of patient medical data, phlebotomy training for blood collection prior and after surgery as needed, potential delivery of samples to the lab for analysis.

This is a high enrolling study that will require travel to other clinics and locations outside of Duke Main Hospital Special skills: Willingness to draw blood and independently travel to a variety of locations.

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

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