Providence Regional Cancer System Clinical Research department is calling a Regulatory Research Specialist to join the team in Lacey, WA.
This is a 0.8 FTE (Day Shift; 32 hours per week) and benefits eligible position.
We are seeking a Regulatory Research Specialist to coordinate and maintain regulatory activities related to clinical trials studies.
In this position you will:
Develop and maintain in-depth knowledge of the standards and policies governing the conduct of clinical studies and the involvement of human subjects, including federal, state and local government regulations, as well as institutional and departmental policies and procedures; conducts studies in accordance with these regulations.
Prepare IRB submission for new studies within the required IRB timelines.
Coordinate the regulatory process for the IRB processing of protocol modifications, consent changes, continuing reviews, protocol variances, safety reports and Investigator Brochures through the Institutional Review Board (IRB).
Collaborate with Clinical Trials Staff and investigators to assure consent changes and consent addendums regarding
Ensure all study-related regulatory documents are maintained in a complete and organized manner.
Conduct Quality reviews of regulatory documents, such as the Regulatory Binder to ensure compliance with applicable FDA regulations, ICH guidelines and current SOPs.
Remain current with changing regulatory requirements to assure compliance with regulatory agency requirements, applicable ICH Guidelines, Good Clinical Practices, and SOPs.
Demonstrate excellent verbal and written communication skills with internal and external personnel in coordinating regulatory process for clinical studies.
Required qualifications for this position include:
High School diploma or GED equivalent.
At least three years' experience as a Clinical Research professional.
Experience with medical terminology.
CITI Human Subjects Protection training during orientation period.
CITI Conflict of Interest training during orientation period.
BLS-CPR during orientation period.
Preferred qualifications for this position include:
Some college related subject matter courses.
Certified Clinical Research professional.
About the clinic you will serve.
Providence Medical Group is a group of more than 125 primary care, specialty care and hospital-based medical providers who serve a five-county region in scenic southwest Washington. Our clinics are located in Aberdeen, Centralia, Lacey, Olympia and Rochester. With an emphasis on the medical home model, our providers and staff strive to create a distinctive health care experience for each patient – one focused on trust, respect, communication and teamwork.
We offer a full comprehensive range of benefits - see our website for details
As people of Providence, we reveal God's love for all, especially the poor and vulnerable, through our compassionate service.
Providence Health & Services is the third largest not-for-profit health system in the United States. Providence employs more than 82,000 caregivers (employees) across a five-state area; AK, WA, MT, OR, and CA. Our facilities include 34 hospitals, 600 physician clinics, senior services, supportive housing and other health and educational services. Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.