Regulatory Administrator, Bogota
Bogotá, Bogota, Colombia
Posted on Tuesday, August 29, 2023
As a physician-founded and led organization, ensuring everyone has access to quality healthcare is what inspires us. That’s why we hire people who genuinely care about patients, solving healthcare challenges, and making a positive impact every day. Join us and help change the future of healthcare for the better.
• 120+ locations and growing, along with vast virtual coverage
• 1 million+ patients to-date
• 2,000+ caring clinicians and support staff serving their communities
• Backed by investors such as CVS Health Ventures and Blackstone Horizon
As we expand our clinical operations from running 3-4 studies to 12-15 studies at a time, the Carbon for Research team needs assistance with maintaining regulatory site files including training documents, credentials, and protocol documents. Files are maintained in a system called Clinically. The Regulatory Assistant will be given materials and assignments by the Central Research Team coordinators.
What You'll Do:
- Staff Training Maintenance: Developing and maintaining a master file of all research staff and their regulatory documents to ensure that their CVs, MLs, GCP, and IATA training are up to date. Assign new and re-training as needed based on expiry.
- Regulatory document maintenance:
- Training Log maintenance: Preparing training logs based on central research team guidance, sending out for signatures, and ensuring signatures are obtained
- Delegation Log maintenance: Preparing delegation logs based on central research team guidance and sending them out for signatures and ensuring signatures are obtained
- IRB and new protocol documents: Any new regulatory documents that are generated - ensure that they are filed in the appropriate study folder - including consent forms
- Building Regulatory folders in Clinical.ly: At the start of a study, build regulatory folders and populate them with information based on the sponsor-provided table of contents.
- System Access Maintenance: Making sure appropriate parties have access to study systems depending on the scope of work/study delegations
- Other remote administrative duties as assigned including but not limited to Patient recruiting, Patient comms/study day management, and various other financial and administrative
- Undergraduate degree required (health-related field is a plus)
- Bilingual English (B2-C1) Level in English
- Great communication skills for building strong relationships
- Minimum of 1 years related experience with clinical research is a plus
- Ability to work within a team and fast space environment
- Very detail oriented
- You are a very motivated and self-initiative collaborator
- Tech Savvy- Ability to learn and manage new tools like Google Suite and other clinical research software.
• Forward-thinking, transparent, and inclusive company culture
• Competitive salary, generous paid time off, learning time off, and paid holidays
• Comprehensive benefits package including medical, dental & vision insurance
• 401k employee contributions, FSA, HSA, and dependent care options
• Employee referral bonus program, employee resource groups, and professional development
• All benefits dependent on role and eligibility
Carbon Health is a leading national healthcare provider with a mission to make high-quality healthcare accessible to everyone. We offer primary and urgent care to nearly two-thirds of the U.S. Leveraging our unique technology platform, we meet patients where they are by delivering care across a variety of access points, including in-person clinics and virtual care. Carbon Health also focuses on value-based care and other value-add services to employers, health plans, health systems and other ecosystem partners.
We recognize that the key to success lies in valuing the minds, experiences and perspectives of people from all walks of life. Carbon Health is proud to value diversity and be an equal opportunity employer. Pursuant to the San Francisco Fair Chance Ordinance and the Los Angeles Fair Chance Initiative for Hiring, we will consider for employment qualified applicants with arrest and conviction records. Carbon Health is an E-Verify employer.