Remote Gcp Auditor Jobs (NOW HIRING)

The START Center for Cancer Research (START) is the worlds largestearly phasesite network, fully dedicated tooncologyclinical research.Throughout ourhistory, START has provided hope to cancer patients inglobalcommunity practices by offering"Hope Through Accesstocutting edgetrials throughout the UnitedStatesand Europe.

We areseekingaSpecialist, Clinical Quality Assurance. This role will ensure clinical operations align with FDA, EMA, and GCP regulations by coordinating Quality Committee activities, supporting the facilitation of external audits, and maintaining standard operating procedures (SOPs). This role oversees controlled documents, supports audit-readiness, and partners with Clinical Operations to drive CAPA activities and continuous improvement.

The annual base salary for this role is $85,000 - $95,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience.

Work Schedule:Monday Friday 8-5p.m

Location:Remote

Essential Responsibilities:

• Facilitate the maintenance of the START centralized Clinical Quality Management System (CQMS) across global START sites.
• Monitor event reporting and initiate the timely kick-off of Corrective and Preventive Action (CAPA) investigation and planning, including the structured completion of root cause analysis (RCA)
• Collaborate with Clinical Operations to monitor the timely completion and documentation of corrective and preventive actions in support of the global CAPA program.
• Collaborate with Compliance to review CAPA dashboards and data for trending events over time.
• Support centralized efforts to prepare, conduct, and respond to external audits and/or inspections with the Global QA and site clinical operations teams.
• Support internal auditing activities to identify and mitigate areas of potential risk and promote audit/inspection readiness across the US sites.
• Coordinate quarterly Quality Committee and SOP Committee scheduling and agenda planning.
• Review and update Standard Operating Procedures (SOPs) in collaboration with Global QA and SOP Working Group members.
• Facilitate SOP training for new issuance of SOPs, SOP revisions, and harmonization initiatives.
• Support special projects requiring QA input, including collaboration with centralized Clinical Training Program implementation and new site launch activities with the Integrations department.
• Identify gaps in controlled documents and recommend solutions.
• Assist in the preparation of quality metrics and reports.
• Assist the QA Director with other clinical QA activities as required.

Education & Experience:

• Bachelors degree or equivalent experience in lieu of degree
• Minimum of 5 years of experience in oncology, clinical research setting (preferably Phase I/Early Phase oncology trials)
• In depth knowledge of GCP, ICH guidelines, EMA and FDA regulations, and the clinical trial lifecycle.
• Proven experience in handling audits, inspections, and CAPA processes is required.

Preferred Education and Experience:

• Additional demonstration of clinical research knowledge as evidenced by the use of either CCRP or CCRC.

Physical and Travel Requirements:

• Required to travel up to 10% of the time
• Sitting
• Standing

Best-in-Class Benefits and Perks

We value the time, talent, and dedication our employees bring to START. Our commitment to your well-being and growth is reflected in a competitive compensation packagebased on experiencealong with comprehensive benefits designed to support you both personally and professionally:

• 401(k) retirement savings plan with employer match
• Eligibility for an annual performance bonus, based on role and company results
• Generous paid time off and paid holidays
• Comprehensive medical, dental, and vision coverageand optional insuranceoptions
• Company paid life and disability insurance for added financial protection
• Employee Assistance Program (EAP) providing confidential, no cost support for you and your family from day one
• Flexible FSA and HSA plans to support your financial wellness
• Commitment to a supportive environment that values balance, wellbeing, and flexibility
• Werecommitted to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START,youlljoin a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation.

More About START

START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. STARTrepresentsthe worlds largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of Hope Through Access.As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda one ofthe most effective cancerdrugsin medical history.

Learn more atSTARTresearch.com.

Ready to be part of a team changing the future of cancer treatment?

Join us in our mission to conquer cancer, one clinical trial at a time. Yourexpertiseand dedication can help us bring hope and healing to patients worldwide.Pleasesubmityour application online.

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.