Clinical Research Coordinator, non-licensed or licensed (Varying Levels); Otolaryngology-Head and Neck Surgery

University of Virginia

10d • Onsite

About The Position

The Department of Otolaryngology-Head and Neck Surgery is currently seeking a non-licensed or licensed Clinical Research Coordinator (CRC). This position is open to applicants who meet the requirements of a CRC 1, 2, 3 or 4. The CRC will work closely with physicians, research staff, study subjects and departmental staff. The successful candidate will be responsible for coordinating all aspects of clinical research from study start-up through to archiving of study records.

The successful candidate will be required to manage multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintain all study documentation in a manner that is ‘audit ready’.
Specific Duties and Role Expectations Include:
Active participation and engagement in the training and mentorship provided that is demonstrated by a continually increasing clinical research knowledge base.
Recruit, screen, and enroll participants who meet study eligibility criteria.
Obtain informed consent from study participants (children, parents, and adult patients) and maintain telephone and in-person contact.
Work with study sponsors and monitors, serving as the liaison between study management and our site, accommodating monitor visits as needed (per study requirements)
Collect and enter data for all trials in a timely fashion, maintain corresponding documentation.
Prepare, submit and manage all study regulatory documents including but not limited to central and local IRB initial protocol submissions, modifications, recruitment materials, continuations, adverse events logs and additional core regulatory documents with oversight from supervisor.
Demonstrate a high level of proficiency using all research IT platforms employed at UVA as well as any IT platforms used in a given clinical trial.
Process, prepare and ship study research samples.
Notify Principal Investigator and supervisor of subject status.
Obtain medical histories, conduct medical assessments of clinical trial subjects including symptom management and adverse event assessment. Provide appropriate guidance to the study PI within the context of the study protocol.
Serve as an information resource and contact to study subjects.
Notify supervisor of any challenges associated with clinical trial conduct or research operations.
Manage research finances including but not limited to budget preparation, invoicing and account reconciliation with training and oversight from supervisor.
Ability to work a flexible schedule, when needed, given the nature of the studies open to enrollment.
Demonstrated experience using basic software programs such as: Word, Excel, Adobe and Power Point.
Perform other duties as assigned.

Requirements

• Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
• MUST be licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy, Registered Respiratory Therapy
• Nursing Diploma may substitute for Degree for Licensed Registered Nurse.

Nice To Haves

• Excellent interpersonal skills, organizational skills and the ability to clearly articulate information to clinicians and other members of the research team.
• Knowledge of clinical research and medical terminology.
• Certified as a clinical research professional (SOCRA or ACRP).

Responsibilities

• Active participation and engagement in the training and mentorship provided that is demonstrated by a continually increasing clinical research knowledge base.
• Recruit, screen, and enroll participants who meet study eligibility criteria.
• Obtain informed consent from study participants (children, parents, and adult patients) and maintain telephone and in-person contact.
• Work with study sponsors and monitors, serving as the liaison between study management and our site, accommodating monitor visits as needed (per study requirements)
• Collect and enter data for all trials in a timely fashion, maintain corresponding documentation.
• Prepare, submit and manage all study regulatory documents including but not limited to central and local IRB initial protocol submissions, modifications, recruitment materials, continuations, adverse events logs and additional core regulatory documents with oversight from supervisor.
• Demonstrate a high level of proficiency using all research IT platforms employed at UVA as well as any IT platforms used in a given clinical trial.
• Process, prepare and ship study research samples.
• Notify Principal Investigator and supervisor of subject status.
• Obtain medical histories, conduct medical assessments of clinical trial subjects including symptom management and adverse event assessment. Provide appropriate guidance to the study PI within the context of the study protocol.
• Serve as an information resource and contact to study subjects.
• Notify supervisor of any challenges associated with clinical trial conduct or research operations.
• Manage research finances including but not limited to budget preparation, invoicing and account reconciliation with training and oversight from supervisor.
• Ability to work a flexible schedule, when needed, given the nature of the studies open to enrollment.
• Demonstrated experience using basic software programs such as: Word, Excel, Adobe and Power Point.
• Perform other duties as assigned.

Benefits

• Salary will be commensurate with education and experience.
• This is a benefited position. Learn more about UVA benefits.
• This is a restricted position, which is dependent on funding and is contingent upon funding availability.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees