Address
SalaryRegulatory Compliance Associate – Fully Remote Position
As a RegulatoryCompliance Associateyou will work collaboratively across multiple CorEvitas departments to support the Quality and Regulatory Compliance team in ensuring CorEvitas’ compliance with regulations, IRB and sponsor obligations, and ethical standards for research while maintaining consistency and quality across regulatory, site, and patient-facing materials.
Your responsibilities will include:
- Supporting in the preparation and filing of regulatory documents across the study lifecycle, including but not limited to:
- Protocol and data collection tool development
- Translation requests
- Deviation reports
- Continuing review requests and site closure requests
- Supporting quality and compliance-related work at the study level, including but not limited to:
- Verifying completeness of site master files and maintaining over the course of the study
- Performing document control including versioning, filing, and archiving of controlled study documents and Standard Operating Procedures
- Answering site-related compliance questions
- Support Quality & Regulatory Compliance Team in regulatory matters
- Attending team meetings; taking notes and tracking departmental action items
- Performs other duties as assigned
Your key strengths include:
- Excellent verbal and written communication skills
- Excellent problem-solving skills
- Proven ability to manage multiple projects simultaneously, without losing track of details
- Proficient with MS Office, Word, PowerPoint and Excel (knowledge of SharePoint and Salesforce a plus)
- Ability to work collaboratively in a remote setting
Additional Experience and Qualifications
- Bachelor’s Degree in related field and 2+ years of regulatory experience preferred
- Experience with IRB communication and employee training
About CorEvitas
CorEvitas, now part of Thermo Fisher Scientific is a science-led, real-world data intelligence company. Using syndicated registry data and analytic services to understand the post-approval comparative effectiveness and safety of approved therapies, CorEvitas provides biopharmaceutical companies with objective data and clinical insights to demonstrate the value of their products to clinicians, patients, payers, and regulators. The company operates nine major autoimmune and inflammatory registries across the U.S., Canada, and Japan, collecting data from over 400 participating investigator sites, including collection of biosamples linked to the deep clinical data. CorEvitas recently expanded its services to include Pregnancy Registries, through the acquisition of Pregistry. CorEvitas also conducts client-sponsored registries through its Patient Powered Registries business, employing a transformative patient-focused registry model to support research needs for patient-centered outcomes across all therapeutic areas. The company’s regulatory-grade registry data is complemented by its Patient Experience business, supporting evidence-based patient engagement initiatives across the product lifecycle, as well as its Specialty EMR Data business and retinal data set. CorEvitas is headquartered in Waltham, MA. www.corevitas.com
CorEvitas is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.
CorEvitas participates with E-Verify
