Position Summary/Essential Duties:

1. Oversees the administrative functions of single and/or multi-institutional research trials. Coordinates/manages daily organization and operational activities related to Phase I-IV clinical research trials. Facilitates key trial communications between the different participating institutions, sponsors and UH. 
2. Coordinates development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by IRB, sponsor and FDA. Collect and review regulatory documents from sites.  
3. Track and provide oversight for the start-up and maintenance of trial activities, enrollment, safety issues and protocol adherence at the different participating institutions.
4. Oversee and coordinate the clinical trials team (external study coordinators, database manager, researchers and statisticians) responsible for data input, analysis and reporting.
5. Organize, coordinate and participate in training for the different participating institutions. Develops and maintains planned communication with sites (ie: study progress updates, newsletters, etc)
6. Assesses investigator and site performance.

Position Summary/Essential Duties:

1. Oversees the administrative functions of single and/or multi-institutional research trials. Coordinates/manages daily organization and operational activities related to Phase I-IV clinical research trials. Facilitates key trial communications between the different participating institutions, sponsors and UH. 
2. Coordinates development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by IRB, sponsor and FDA. Collect and review regulatory documents from sites.  
3. Track and provide oversight for the start-up and maintenance of trial activities, enrollment, safety issues and protocol adherence at the different participating institutions.
4. Oversee and coordinate the clinical trials team (external study coordinators, database manager, researchers and statisticians) responsible for data input, analysis and reporting.
5. Organize, coordinate and participate in training for the different participating institutions. Develops and maintains planned communication with sites (ie: study progress updates, newsletters, etc)
6. Assesses investigator and site performance.

Education.

Bachelor’s degree required. Minimum 3 years of clinical trial experience as a study coordinator, project manager, budget or contract research associate or equivalent management experience within the clinical research field. Knowledge of FDA regulations, ICH and GCP guidelines and their applications to clinical research trials.

Required Credentials, License, and / or Certifications.

CITI Training within 3 months of hire. SoCRA or ACRP certification preferred.

Experience & Knowledge:

Minimum 3 years of clinical trial experience as a study coordinator, project manager, budget or contract research associate or equivalent management experience within the clinical research field. Knowledge of FDA regulations, ICH and GCP guidelines and their applications to clinical research trials.

Special Skills & Equipment Knowledge:

Requires excellent interpersonal, organizational and project management skills. Excellent problem solving skills. Ability to understand and communicate data requirements to others. Demonstrate ability to work with multiple software technologies.

This role encounters Protected Health Information (PHI) as part of regular responsibilities. UH employees must abide by all requirements to safely and securely maintain PHI for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.