Senior Clinical Research Coordinator

Position: Senior Clinical Research Coordinator 2
* Studies have high complexity with limited oversight.
* Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities.
* Acts as a leader within the department/unit through improving clinical research practice and serving as a resource.
* Accountable for high standards of clinical research practice and assists in the development of accountability in others.
* Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
* Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations.
* Prepares, submits, and assists investigators with multiple levels of research documentation, such as IRB submissions, educational materials, reports, grant renewal reports, and study forms.
* Maintains regulatory documentation.
* Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
* Provides direct supervision of other clinical research staff, such as hiring/firing, performance evaluations, disciplinary actions, approve time off, etc., or assistance.
* Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.
* Prepares program conference lists for multidisciplinary conferences and workshops. Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
* Solves a range of complex problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
* Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.
* Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.
* Performs other related work as needed.

- Manages high complexity clinical studies and owns administrative tasks. Assists with strategic planning for the research department. Trains lower-level roles.

- Maintains working knowledge of current protocols and internal SOPs.

- Provides investigators with guidance regarding protocol requirements.

- Attends continuing education and training opportunities relevant to job duties.
** Preferred Qualifications
*** Bachelor’s degree.
** Technical Skills or Knowledge:
*** Read and understand clinical trials protocols.
* Familiarity with medical terminology/environment.
* Working knowledge of good clinical practices (GCP).
* Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.
* Comprehend technical documents.
* Understanding of the federal research regulations and identify the federal research organizations’ role in regulating human research participation.
** Preferred Competencies
*** Train junior CRCs; train or teach others.
* Participate in protocol review and clinical trials evaluations.
* Excellent interpersonal skills.
* Strong data management skills and attention to detail.
* Handle competing demands with diplomacy and enthusiasm.
* Work collaboratively with faculty and divisional clinical research infrastructure.
* Excellent time management and prioritize work assignments.
* Communicate in writing.
* Communicate orally.
* Develop and…