Regulatory Affairs Specialist 8/21/2020
Sarah Cannon Network
JOB DESCRIPTIONAPPLY DESCRIPTION SHIFT: No Weekends
SARAH CANNON DEVELOPMENT INNOVATIONS is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute's Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.
Sarah Cannon Development Innovations works with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations' therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.
* Tuition Reimbursement/Assistance Programs
* Paid Personal Leave
* 401k (100% annual match - 3%-9% of pay based on years of service)
* Identity Theft Protection discounts
* Auto, Home, and Life Insurance options
* Adoption Assistance
* Employee Stock Purchase Program (ESPP)
As a REGULATORY AFFAIRS SPECIALIST your primary responsibilities include planning and managing regulatory affairs compliance for assigned clinical trials. You will work closely with the project teams to ensure compliance while meeting strict deadlines.
* You will prepare Central Institutional Review Board (IRB) and/or ethics committee submissions (protocol, amendments, consents, investigator brochures, safety updates) for assigned studies
* You will review essential trial documents to ensure accuracy, completeness, and compliance with ICH/GCP guidelines, local standard operating procedures (SOPs), and sponsor requirements
* You will determine site regulatory readiness for site activation
* You will assist in ClinicalTrials.Gov trial registration, updates and ongoing maintenance of trial status, as applicable
* You will query sites for correction and/or revision of regulatory documents or request sites submit missing documents
* You will review informed consent form templates and any changes made by investigative sites to ensure compliance with CFR, GCP, HIPAA, and study-specific requirements
* You will assist project teams in maintaining accurate and current essential documents
* You will distribute safety updates for assigned studies
* You will support teams by serving as subject matter expert regarding essential documents, GCP, and regulatory policy
* You will assist project teams with preparation for and participation in internal and external audits
* You will apprise Department Manager and other leadership, as appropriate, of all study and site-specific regulatory issues for guidance and follow through
* You will archive study specific regulatory documentation and correspondence
* You will contribute to team decision-making concerning departmental policies, regulatory requirements, strategies and SOPs
QUALIFICATIONS YOU SHOULD HAVE FOR THIS POSITION:
* An Associate's Degree, preferably a Bachelor's Degree
* Knowledge of regulatory, medical, and clinical research terminology
* Knowledge of IRB, FDA and GCP guidelines
* At least two years of experience in healthcare, research, science or other professional field, one of which is in clinical research or regulatory affairs
If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Regulatory Affairs Specialist opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!
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