Clinical Operations Counsel at Jobot
Ontario, CA 91761
About the Job
Clinical Ops for a large healthcare system
This Jobot Job is hosted by: Sherwin Souzankari
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $200,000 - $250,000 per year
A bit about us:
We're a nationwide hospital system that owns and operates over 40 hospitals across the country. We're growing our legal team and are excited to talk about this expansion!
Why join us?
Job Details
Position Overview:
The Clinical Operations Counsel will provide legal counsel and support to our clinical operations teams, ensuring compliance with regulatory requirements and industry best practices. The ideal candidate will have a strong background in healthcare law, clinical trials, regulatory compliance, and a minimum of 6-7 years of relevant experience. Holding an RN (Registered Nurse) license is highly desired for this role. This position offers the opportunity to work closely with cross-functional teams to navigate complex legal issues and drive the success of our clinical initiatives.
Key Responsibilities:
1. Legal Support for Clinical Trials:
- Provide expert legal guidance and support to clinical operations teams during the planning, execution, and management of clinical trials.
- Draft, review, and negotiate contracts and agreements related to clinical research, including investigator agreements, site agreements, and vendor contracts.
2. Regulatory Compliance:
- Stay informed about evolving regulations and industry standards related to clinical research and healthcare.
- Ensure strict compliance with FDA and other regulatory agency requirements, including the development of compliant processes and policies.
3. Risk Assessment and Mitigation:
- Conduct thorough risk assessments and identify legal and regulatory risks associated with clinical operations.
- Develop and implement comprehensive strategies to mitigate those risks.
4. Contract Management:
- Oversee the management of a repository of clinical research contracts and agreements.
- Monitor contract milestones, renewals, and terminations to ensure compliance.
5. Investigator Relationships:
- Cultivate and maintain positive relationships with clinical trial investigators, research sites, and other external partners.
6. Legal Documentation:
- Prepare and review legal documentation, including informed consent forms, data use agreements, and confidentiality agreements.
Qualifications:
1. Juris Doctor (JD) degree from an accredited law school.
2. Active membership in good standing with the state bar association.
3. Minimum of 6-7 years of legal experience, with a strong focus on healthcare law, clinical operations, and regulatory compliance.
4. Exceptional understanding of FDA regulations and clinical research compliance.
5. RN (Registered Nurse) license is highly desired.
6. Excellent written and oral communication skills.
7. Ability to work collaboratively in a cross-functional team environment.
8. Detail-oriented with strong analytical and problem-solving abilities.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Sherwin Souzankari
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $200,000 - $250,000 per year
A bit about us:
We're a nationwide hospital system that owns and operates over 40 hospitals across the country. We're growing our legal team and are excited to talk about this expansion!
Why join us?
- Competitve comp
- Great team
- Growth Environment
Job Details
Position Overview:
The Clinical Operations Counsel will provide legal counsel and support to our clinical operations teams, ensuring compliance with regulatory requirements and industry best practices. The ideal candidate will have a strong background in healthcare law, clinical trials, regulatory compliance, and a minimum of 6-7 years of relevant experience. Holding an RN (Registered Nurse) license is highly desired for this role. This position offers the opportunity to work closely with cross-functional teams to navigate complex legal issues and drive the success of our clinical initiatives.
Key Responsibilities:
1. Legal Support for Clinical Trials:
- Provide expert legal guidance and support to clinical operations teams during the planning, execution, and management of clinical trials.
- Draft, review, and negotiate contracts and agreements related to clinical research, including investigator agreements, site agreements, and vendor contracts.
2. Regulatory Compliance:
- Stay informed about evolving regulations and industry standards related to clinical research and healthcare.
- Ensure strict compliance with FDA and other regulatory agency requirements, including the development of compliant processes and policies.
3. Risk Assessment and Mitigation:
- Conduct thorough risk assessments and identify legal and regulatory risks associated with clinical operations.
- Develop and implement comprehensive strategies to mitigate those risks.
4. Contract Management:
- Oversee the management of a repository of clinical research contracts and agreements.
- Monitor contract milestones, renewals, and terminations to ensure compliance.
5. Investigator Relationships:
- Cultivate and maintain positive relationships with clinical trial investigators, research sites, and other external partners.
6. Legal Documentation:
- Prepare and review legal documentation, including informed consent forms, data use agreements, and confidentiality agreements.
Qualifications:
1. Juris Doctor (JD) degree from an accredited law school.
2. Active membership in good standing with the state bar association.
3. Minimum of 6-7 years of legal experience, with a strong focus on healthcare law, clinical operations, and regulatory compliance.
4. Exceptional understanding of FDA regulations and clinical research compliance.
5. RN (Registered Nurse) license is highly desired.
6. Excellent written and oral communication skills.
7. Ability to work collaboratively in a cross-functional team environment.
8. Detail-oriented with strong analytical and problem-solving abilities.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
200,000 - 250,000 /year