3+ years of clinical trial experience in roles such as study coordinator or project manager
Knowledge of FDA regulations, ICH, and GCP guidelines
Strong interpersonal, organizational, and project management skills
Excellent problem-solving abilities
Proficient in communicating data requirements
Familiarity with multiple software technologies
Responsibilities
Oversee administrative functions of clinical research trials
Coordinate development and approval of research protocols and regulatory documents
Track trial activities, enrollment, and protocol adherence
Manage the clinical trials team for data input and analysis
Organize training and maintain communication with participating institutions
Assess investigator and site performance
Benefits
CITI Training required within 90 days
SoCRA or ACRP certification preferred
Opportunities for professional development
Collaborative work environment
Engagement with multiple institutions and stakeholders
Full Job Description
What You Will Do
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. (20%)
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. (20%)
Track and provide oversight for the start-up and maintenance of trial activities, enrollment, safety issues and protocol adherence at the different participating institutions. (20%)
Oversee and coordinate the clinical trials team (external study coordinators, database manager, researchers and statisticians) responsible for data input, analysis and reporting. (10%)
Organize, coordinate and participate in training for the different participating institutions. Develops and maintains planned communication with sites (ie: study progress updates, newsletters, etc) (10%)
Assesses investigator and site performance. (10%)
Additional Responsibilities
Performs other duties as assigned.
Complies with all policies and standards.
For specific duties and responsibilities, refer to documentation provided by the department during orientation.
Must abide by all requirements to safely and securely maintain Protected Health Information (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.
Qualifications: Education
Bachelor's Degree (Required)
Work Experience
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. (Required)
Knowledge, Skills, & Abilities
Knowledge of FDA regulations, ICH and GCP guidelines and their applications to clinical research trials. (Required proficiency)
Excellent interpersonal, organizational and project management skills. (Required proficiency)
Excellent problem solving skills. (Required proficiency)
Ability to understand and communicate data requirements to others. (Required proficiency)
Demonstrate ability to work with multiple software technologies. (Required proficiency)
