Duration : 6 month contract to permanent hire

Location: Pleasanton, CA - 4 days a week on-site

Insight Global's Healthcare Client's Clinical Trials Program (CTP) is a regional organization that conducts clinical trials across all Northern CA medical centers to provide members with the latest opportunities in therapeutic and diagnostic strategies, other types of clinical research and novel technology. This includes clinical trials led by physicians, Division of Research non-MD investigators and other researchers. We provide members access to preventive agents and therapies across the spectrum of therapeutic areas (e.g., vaccines, cardiology, adult and pediatric hematology/oncology, nephrology, neurology, peripheral artery disease, etc.). The CTP also directly supports access to compassionate use therapies for members with life threatening conditions, including obtaining IRB approval, coordinating with sponsors to receive the therapy, and quality monitoring and required reporting.

The Director of Regulatory and Quality leads both regulatory and quality functions for the CTP. This position is responsible for managing Regulatory and Quality functions, developing Systems to ensure compliance with sponsored clinical trials standards and regulations, including 21 CFR Parts 11, 312 and 812. In addition, this position leads CTP in a comprehensive knowledge of FDA, GCP, GDPR regulations and ICH E6 R2 guidelines. This position reports to the Managing Director, Clinical Trials Program

Primary Duties and Responsibilities:

● Providing regulatory and quality consultation as a subject matter expert

● Provides both Regulatory and Quality training to Investigators, CTP team members, and at large training.

● Understanding regional, provincial, and federal laws that apply to the Northern CA region.

● Writing clear, informative reports that highlight the main findings.

● Discussing quality standards and how to accomplish them with other employees.

● Understanding customer needs and requirements to develop effective quality control processes.

● Submitting reports and communicating with IRB and regulatory agencies

● Staying abreast of developments in GCP and federal regulations regarding clinical research.

● Assisting with QC and QA of various study related regulatory documents and reports.

● Assisting with training and mentoring of junior regulatory specialists and departmental QC and QA activities

● Ensures quality management system requirements are effectively established and

it is maintained per GCP and Human Subject Protection standard regulations.

● Leads the development and execution of quality policy, objectives, and strategic plans.

● Directs and oversees all Quality Systems staff and functions in areas including FDA and ICH regulations and guidelines, document control, management review, corrective and preventive actions (CAPA), deviations, change control, internal audits, employee training, supplier management, risk management activities, application validation documentation, surveillance and complaints.

● Serves as lead contact for inspections by regulatory agencies and sponsor audits.

● Develops, reviews, strengthens, and approves all CTP-controlled documents including policies, SOPs, validation documents, change control, deviations and CAPAs.

● Develops, plans, and leads readiness for inspections and audits at CTP by GCP and

GxP regulatory authorities, clinical investigator sites, and contract organizations.

● Conducts data auditing and review in support of regulatory submissions and periodic

safety reports.

● Chairs and coordinates quality management review meetings and oversees action items.

● Ensures completion of all corrective actions associated with the quality system and

ensures that the CAPA process is compliant with regulatory requirements.

● Ensures all deviations are investigated, closed, tracked, trended, and checked for

Effectiveness.

● Leads in developing CTP staff with a set of tools and training to conduct effective root cause analysis

● Reports quality compliance metrics to CTP officers and provides recommendations for improvements.

● Oversees and performs audit processes, including managing audit resources, tracking

status of audit findings to closure, and audit record retention.

● Assists with the regulatory submissions made to FDA and all other regulatory agencies to obtain clinical approvals and respond to inquiries

● Performs other duties as related to providing quality program direction and to the mission, goals, and values of CTP.