Clinical Research Operations Manager

Job Responsibilities:

• Participates with the PI, Program Director and Center faculty in preparing research grant and contract proposals, and in designing and/or implementing new research projects in the clinic as the leader of a large staff of nurses and coordinators.
• Manages the clinic staff.
• Meets with the PI, Program Director and Center faculty regularly to review studies that are enrolling participants, are in active follow up, or are starting imminently. Serves as the staff leader and participates in planning and evaluating these projects. Leads staff meetings on a weekly basis.
• Participates in weekly or recurring protocol team meetings with national/international sponsors (NIH, industry, academia) and collaborators and/or vaccine center teams.
• Oversees the clinic staff to ensure appropriate enrollments, consents, procedures, safety evaluations, documentation, and specimens are completed. Assure proper GCP training and performance of all team members.
• Demonstrates skill in handling challenging clinical research situations when need arises. Participates in monitoring/maintaining a safe environment for staff, visitors and patients through hazard-identification and reporting accident prevention.
• Provides research staff with instruction and teaching materials pertinent to protocol, investigational product, and disease management.
• Participates in formal evaluation of own progress, and that of all supervised staff, setting goals toward improvement.
• Updates practices in accordance with clinical research standards or professional trends. Seeks advanced learning/development experiences independently (e.g., workshops, seminars, conferences, courses). Regularly reviews current research coordinator literature and shares significant information with staff. Participates actively in professional organizations.
• Position requires ongoing continuing education in all areas of research development (training programs are provided through the SOM). Promotes own professional growth and development in research role and maintains current expertise in area of practice. Maintains annual requirement in continuing research education; employee must demonstrate proof of ongoing research education. Serves as a resource to peers and works collaboratively with other disciplines within the area of expertise.
• Assume responsibility and accountability for assigned responsibilities.
• Helps lead staff educators, and participates in community education, engagement and recruitment activities.
• Sets priorities in management of other staff. Able to mentor the staff and help them be successful.
• Other duties as assigned by Center director and program director. 
• Meets deadlines as required.
• Communicates appropriate information within organization in a timely manner. Reports promptly and accurately all significant clinical events to clinician. Ensures accuracy, usefulness and completeness of all clinic and departmental records and manuals. Contributes to a climate supportive of all departmental and institutional activities.
• Establishes communication with other health professionals to promote and implement research within assigned unit/department. Collaborates with regulatory coordinator in monitoring all activities, evaluating results and documenting same. Actively participates in appropriate committees within the Department or Institution.
• Contributes to and publishes relevant research findings in collaboration with research staff. Communicates published research findings to staff members. Prepares reports/abstracts for conferences and publication.
• Supervision of other research clinic staff. Key manager position reporting to Program Director-VTEU.