Medasource
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Title: Regulatory Support Specialist
Start Date: ASAP
Location: Pleasanton, CA, 5 days/week in person
Contract: 3 month Contract to Hire
The Regulatory Support Specialist, under director of the Clinical Trials Compliance Director, will provide regulatory support to the Northern California PI and research sites conducting multiple FDA-regulated or other clinical trials.
Responsibilities:
- Compliance Monitoring and Reporting with IRB Standard Operating Procedures and document applications
- Adhere to Guideline for GCP, federal, sate, and local regulations
- Assist with the preparation for internal and external inspections, audits and monitor visits
- Assist in assuring that all site documents, including SOPs and study regulatory files, are maintained in audit-ready condition
- Maintain communication with internal/external parties and research team regarding regulatory document matters
- Work with an assigned mentor on a regular basis for training and resource questions
- Attend Sponsor site initiation meetings
Requirements:
- 3+ years of experience in Clinical Trials and GCP for all research designs
- Bachelor’s Degree in related field
- Drug-related trial experience
- Proficiency with Microsoft Office and Adobe Acrobat
Soft Skills:
- Demonstrate excellent organizational skills
- Must be able to work successfully with a wide variety of project staff and research participants
- Must be dependable and able to follow detailed protocols precisely
- Have ability to work with shifting priorites
- Exhibit a professional manner with a high degree of courtesy, tact, and sensitivity
- Work well independently as well as part of a larger multi-disciplinary research team
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
JO-2501-158088