Under the direction of the Senior Clinical Trials Manager of North Bay Neuroscience Institute (NBNI), this person is responsible as an operational leader in clinical trials research to oversee the daily research activities within single or multiple trials. He/she is responsible to ensure compliance with federal, state and local regulations, as well as FDA, Guidelines for Good Clinical Practice, 21 CFR and NBNI policies and procedures pertaining to investigational drug and/or device pharmaceutical studies. This CTC is identified as a role model, educator, coach, preceptor, resource and supervisor.
Bachelor’s Degree in Scientific/Health related field or equivalent years of experience.
5+ years Clinical Research/Development experience required, including relevant Clinical Trial Management experience. CCRC highly desirable. SoCRA or ACRP certification preferred.
Experience with project and vendor contract management.
Knowledge of Good Clinical Practice (GCP) and FDA regulations is expected. Experience with Institutional Review Board (IRB) preparations and submission helpful.
Experience writing, reviewing and editing clinical protocols and study reports.
Ability to exercise judgment and determine appropriate action given guidelines.
Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from other managers, external vendors, regulators and subjects.
Ability to work independently and manage deadlines. Project management experience preferred.
Knowledge of both medical and study terminology.
Knowledge of principles, methods and procedures of basic medical and/or clinical research
Knowledge and understanding of human research protection policies regulations, procedures and standards as applied to IRB and compliance operations.
Knowledge of ICH Guidelines for Good Clinical Practice
Comprehensive working knowledge of the clinical research process including the FDA Code of Federal Regulations (21 CFR Part 11,50,54,56,58,312,812).
Ability to work in a team environment.
Some travel to attend Study conferences.
Internal Number: none
About North Bay Neuroscience Institute
The Research Institute is engaged in providing major medical information through clinical drug trials, introducing new techniques, and exploring and encouraging the best medical and healing practices. To date there are research programs engaged for Alzheimer’s studies.
Future interests include exploring better outcomes in medical care for Parkinson’s disease patients, and we will actively encourage programs in behavioral medicine, nutrition, life style changes, and herbal medicine, as well as new uses of older and traditional treatments.