We are a pharmaceutical clinical trial site. Under the direction of the Director of North Bay Neuroscience Institute (NBNI), this person is responsible as an operational leader in clinical trials to oversee the daily trial activities within single or multiple trials. He/she is responsible to ensure compliance with each study protocol, GCP and NBNI policies and procedures pertaining to investigational drug/pharmaceutical studies. This CTC is identified as a role model, educator, coach, preceptor, resource and supervisor.
Initiate and coordinate each study including pre-study communications and development with sponsors, determining NBNI site needs by developing details of related equipment, staffing and supply demands and with following all protocol implementation.
In-depth knowledge of clinical trial protocols and regulations as well as knowledge and experience in implementation procedures. Lead and develop training and education of NBNI staff regarding protocol.
Study Subject engagement and management including interviewing and rating.
Responsible for keeping each study on time according to timeline agreed by sponsor.
Proactively manage and coordinate documentation and tracking forms to assist with data collection and recording.
Monitoring study details through both sponsor and in-house tracking software.
Manage NBNI internal compliance monitoring following both study protocol and Good Clinical Practices (GCP).
Lead, coordinate and participate in sponsor or other regulatory authority monitoring visits and follow-up on outstanding queries and clinical trial issues.
Coordinate enrollment in the study from screening to completion and closure. Includes any study-related requirements including drug accountability, data collection, candidate/subject scheduling, specimen shipping, adverse events management, subject concerns and questions. Participates in NBNI study team meetings. Resource for troubleshooting operational issues within the program.
Develop NBNI study SOPs under direction of the PI and Director.
Work with fellow NBNI staff (RNs, MAs, Pharmacist, etc.) to build an effective, efficient and compliant team.
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 management.
Knowledge of Good Clinical Practice (GCP) and FDA regulations is expected. Experience with Institutional Review Board (IRB) preparations and submission helpful.
Experience in understanding and implementing 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.
Familiarity with CTMS software and IxRS services for trial management.
Familiarity with Google data services (Drive, Docs, Sheets, gMail)
Additional Salary Information: salary will be entirely based on years of relevant experience
About North Bay Neuroscience Institute
The Institute is engaged in providing major medical information through pharmaceutical clinical drug trials, introducing new techniques, and exploring and encouraging the best medical and healing practices. To date our research programs are primarily engaged in Alzheimer’s studies.