ObjectiveHealth
Regulatory Specialist at ObjectiveHealth
Description The Regulatory Specialist coordinates and participates in all regulatory research activities across ObjectiveHealth sites. Responsibilities include preparing, reviewing, managing, and tracking study‑specific regulatory documents and training documentation, maintaining delegation of authority and training logs, and ensuring GCP compliance while meeting strict deadlines.
Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to improve patient access to research trials, provide physicians with enhanced care options, and deliver superior clinical research enrollment metrics to pharma sponsors. Our goal is to improve patient outcomes at the point of care.
Key Responsibilities
Maintain regulatory start‑up and ongoing documentation throughout clinical trials.
Ensure compliance with all IRB‑approved protocols, sponsor requirements, company SOPs, HIPAA regulations, GCPs, and applicable state and federal laws.
Create, review, file, and submit regulatory and training documents, ensuring completeness and accuracy.
Track and maintain physician credentials, training logs, and delegation of authority forms.
Follow up on pending signatures and missing documentation to ensure timely completion.
Collaborate with internal teams, research staff, investigators, and external sponsors to facilitate effective communication and issue resolution.
Prepare IRB submissions (initial protocols, amendments, safety updates, etc.).
Review and edit Informed Consent Forms for regulatory and protocol compliance.
Participate in study start‑up, monitoring visits, internal/external audits, and regulatory inspections.
Maintain up‑to‑date knowledge of clinical research regulations, GCP, and FDA/ICH guidance.
Provide regulatory training to site staff as needed.
Qualifications
Bachelor’s degree in life sciences, healthcare, or related field (preferred).
2+ years of experience in clinical research regulatory affairs or a similar role.
Strong understanding of GCP, ICH guidelines, FDA regulations, and IRB processes.
Excellent organizational, communication, and documentation skills.
Ability to manage multiple priorities and deadlines with strong attention to detail.
What We Offer Competitive compensation, 401(k) with company match, a clear career pathway for advancement, short‑ and long‑term disability, health savings and flexible spending accounts, health, dental, and vision insurance plans, generous PTO, adoption assistance, paid holidays, and a wide selection of other voluntary benefits.
Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E‑Verify participant.
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Description The Regulatory Specialist coordinates and participates in all regulatory research activities across ObjectiveHealth sites. Responsibilities include preparing, reviewing, managing, and tracking study‑specific regulatory documents and training documentation, maintaining delegation of authority and training logs, and ensuring GCP compliance while meeting strict deadlines.
Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to improve patient access to research trials, provide physicians with enhanced care options, and deliver superior clinical research enrollment metrics to pharma sponsors. Our goal is to improve patient outcomes at the point of care.
Key Responsibilities
Maintain regulatory start‑up and ongoing documentation throughout clinical trials.
Ensure compliance with all IRB‑approved protocols, sponsor requirements, company SOPs, HIPAA regulations, GCPs, and applicable state and federal laws.
Create, review, file, and submit regulatory and training documents, ensuring completeness and accuracy.
Track and maintain physician credentials, training logs, and delegation of authority forms.
Follow up on pending signatures and missing documentation to ensure timely completion.
Collaborate with internal teams, research staff, investigators, and external sponsors to facilitate effective communication and issue resolution.
Prepare IRB submissions (initial protocols, amendments, safety updates, etc.).
Review and edit Informed Consent Forms for regulatory and protocol compliance.
Participate in study start‑up, monitoring visits, internal/external audits, and regulatory inspections.
Maintain up‑to‑date knowledge of clinical research regulations, GCP, and FDA/ICH guidance.
Provide regulatory training to site staff as needed.
Qualifications
Bachelor’s degree in life sciences, healthcare, or related field (preferred).
2+ years of experience in clinical research regulatory affairs or a similar role.
Strong understanding of GCP, ICH guidelines, FDA regulations, and IRB processes.
Excellent organizational, communication, and documentation skills.
Ability to manage multiple priorities and deadlines with strong attention to detail.
What We Offer Competitive compensation, 401(k) with company match, a clear career pathway for advancement, short‑ and long‑term disability, health savings and flexible spending accounts, health, dental, and vision insurance plans, generous PTO, adoption assistance, paid holidays, and a wide selection of other voluntary benefits.
Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E‑Verify participant.
#J-18808-Ljbffr