The Department of Surgery and Orthopedics Clinical Research Coordinator will support clinical research activities for the department, division, and/or center. This position will serve as a vital resource for investigators to partner and facilitate the conduct of various research studies and liaison with research administration as well as various institutional committees. The incumbent will serve as a point of contact for assigned areas and provide day to day support to the ongoing studies, publications, presentations, posters, and other academic work as assigned. As a result, the clinical research coordinator will help to advance research throughout the department and divisions as assigned. This position will also support projects and assumes responsibility for the day-to-day operation of program activities, including the regulatory functions, project management, administrative tasks, study conduct, chart review, study enrollment, basic data analysis, RedCap, interpretation of results and reporting of research studies and experiments. Possesses advanced knowledge of research practices.

Essential Functions:

1. Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required to ensure compliance with sponsor and regulatory guidelines; oversee clinical research projects within the department and divisions.

2. Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals. Maintains scientific knowledge and understanding of peer-reviewed publications for application to current methodologies.

3. Participates in the design and completion of study protocols; including but not limited to regulatory support and maintenance, the conduct of parental permission/assent process for assigned studies; enrolls study participants; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.

4. Performs clinical data gathering, measurements including medical record review when needed and monitoring of data integrity, including data completeness, accuracy, and quality. Maintains and contribute to the creation of multiple study databases, including but not limited to RedCap. Ability to submit data proactively, address queries in a timely manner and identify and resolve concerns related to research projects.

5. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.

6. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems

7. Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation.

8. Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples

9. Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for internal and external audits by sponsor, IRB and/or the FDA/DHHS.

10. Participates in continuous process improvement initiatives and implementation of outcomes. Advise and collaborate with Principal Investigators on strategies to enhance research activity.

11. Provide non-technical writing, formatting, and editing support; inclusive of budget justifications, biographical sketches, institutional background descriptions, references, appendices, and other proposal documents. Assist the PI and research team prepare presentations for scientific meetings, describing the methodology and results; prepare manuscripts for publication in peer-reviewed journals; and prepare grant applications.

Qualifications:

• Bachelor's degree in medical or science related field required
• 1-3yrs Experience with facilitating research projects and regulatory functions, Clinical Research Certification (CCRP, CCRC) preferred