The Senior Compliance Specialist is an experienced professional with a comprehensive understanding of quality assurance and GCP regulatory expectations. This position will work closely with the clinical team providing quality guidance on vendor selection, procedure development and revision as well as planning and execution of vendor audits and site audits. The successful candidate is self-motivated, independent, highly organized and able to work in a small team environment. The Senior Compliance Specialist must multitask and adjust direction based on changing project/corporate priorities.
Management of the vendor audit schedule and tracking of the audit status
Conduct of vendor assessments including review and assessment of supporting documentation such as audit reports and vendor questionnaires
Conduct of on-site vendor audits
Management of study specific site audit schedule and tracking of audit status
Review and assessment of site audit reports and trending of observations across study
Conduct of site audits
Conduct of internal audits including the conduct of audits of Trial Master Files
Development, revision, and review of Standard Operating Procedures
Review of Quality System documents such as Deviations, CAPA
Quality review and audit of documents such as Clinical Study Reports, Clinical Quality Plans, Development Safety Update Reports
Conduct of Risk Assessments and Management of Risk Remediation Plans
SKILLS & REQUIREMENTS:
Bachelor's Degree in health sciences related field
4+ years of experience working in Clinical Quality Assurance
Thorough knowledge of ICH/GCP guidelines
Strong written and verbal communication ability
Strong PC skills (MS Word, MS Excel, MS Project)
Ability to travel 15-20% required
Corbus is a close-knit team of almost 100 employees who are high-achievers, innovative, creative and, above all else, passionate about what we do. We hire for personality as well as for skill.
You must thrive in an entrepreneurial and autonomous environment where you will succeed based on your contribution and work ethic, not on your title or rank. At Corbus we take pride in our "family" atmosphere where each person's contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here. Positive, team-oriented people work at Corbus and are rewarded with fun perks like weekly food deliveries to our kitchen, a monthly in-house massage therapist, company-paid classes with Title Boxing, and organized company activities and outings. Additionally, Corbus offers an attractive, comprehensive benefits package.
Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company's lead product candidate, Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer
Corbus Pharmaceuticals Holdings, Inc.