Clinical Trial Manager

About Us:

We are a highly engaged research clinic managing multiple contracts with the NIH and pharmaceutical companies. Our focus is on performing clinical studies to prevent HIV as part of the large NIH network called The HIV Vaccine Trials Network (HVTN), funded by a 7-year NIH grant.

Job Description:

As the Manager of Clinical Research Coordination, you will play a crucial role in managing and overseeing the development and implementation of research initiatives at our clinic. Your primary responsibility will be to ensure that project milestones and goals are achieved, and clinical studies are conducted effectively. You will directly lead and support our dedicated team at the UR Vaccines to Prevent HIV CRS.

Key Responsibilities:

• Facilitate daily coordination of all clinical research coordinators/nurses and administrative staff.

• Ensure quality management of clinical operations within the HVTN CRS.

• Collaborate with the clinical team to review proposed budgets and submit contracts.

• Consult with PIs and research staff to evaluate and achieve research protocol objectives.

• Oversee project milestones and progress, keeping investigators informed.

• Implement strategies to increase study recruitment and enrollment.

• Monitor and report on unanticipated occurrences and protocol deviations.

• Provide oversight and training to study personnel, ensuring compliance with regulations.

• Maintain all regulatory documentation and submissions to IRBs and other regulatory bodies.

• Assist in preparing project-specific reports and the annual report for the NIH.

Successful Candidates Posses:

• Demonstrated leadership skills and competency.

• Proficiency in managing complex research protocols and procedures.

• Knowledge of medical terminology, clinical research processes, and regulatory guidelines.

• Strong organizational and time management skills.

• Thorough understanding of GCP and Responsible Conduct of Research standards.

• Exceptional interpersonal skills and the ability to build collaboration.

• Proficient in MS Office (Word, Excel, PowerPoint) and internet usage.

• Highly self-motivated and able to function independently.

Qualifications:

Bachelor's Degree required; Master's degree in a health-related field preferred.

At least 4 years of clinical research or relevant work experience (or equivalent combination of education and experience).

1 year of leadership experience preferred.