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Study Start-up & Operations Associate

Employer
Formation Bio
Location
New York
Start date
Mar 22, 2023

View more

Discipline
Manufacturing & Production, Operations
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country

Job Details

About TrialSpark

On a mission to bring new treatments to patients faster and more efficiently 

Founded in 2016, TrialSpark is a tech-driven Pharma company differentiated by radically more efficient drug development. TrialSpark has built a technology platform that optimizes all aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data. 

The company acquires clinical-stage drugs from pharmaceutical and biotech companies and develops them faster, unlocking greater value per program and accelerating access to new treatments for patients. TrialSpark's current therapeutic areas of focus include rheumatology, dermatology, CNS, and cardiometabolic diseases.

About the Position

The Study Start-up & Operations Associate will manage regulatory activity for clinical research trials TrialSpark is engaged in. They will work with the Principal Investigators (PIs) and their site teams to ensure the sites meet federal and state regulatory requirements ensure our studies meet, including supporting study and site startup, reporting, and closeout submissions to Institutional Review Boards (IRB) and relevant regulatory agencies and sponsors. This person will ensure the essential documents for a site are complete, compliant, and accurate and that the essential documents are appropriately tracked and filed in the TS eTMF at start-up and throughout the study.

Given the importance of sound regulatory execution in ensuring patient safety, quality, and compliance, this team member must have impeccable judgment, high attention to detail, a strong work ethic, and high ethical standards. 

Responsibilities

  • Maintain a working understanding of Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and Good Clinical Practice (GCP) policies and guidelines as they relate to the conduct of human clinical trials.
  • Understanding of the research protocols and the ability to translate research requirements into appropriate regulatory actions.
  • Preparation and maintenance of all regulatory matters, including site-level essential documents (, CVs, licenses, etc.), IRB submissions, and governmental regulatory documents (e.g., FDA 1572s). 
  • Partner closely with Clinical Operations, QA, and other functions to weave regulatory excellence into our organization.
  • Support of study and site start-up regulatory activities, ongoing IRB continuing reviews, modifications, and study closeout regulatory documents. 
  • Supporting Training team in education for Clinical Research staff on regulatory standards.
  • Managing archiving of clinical trial documents and records per government and sponsor standards. 
  • Preparation for internal and external inspections, audits and monitoring visits, including partnering with the QA team and clinical research associates.

About You 

  • Bachelor’s degree (B.S. preferred).
  • Minimum of 3 years experience in clinical research space, as a regulatory specialist, eTMF administrator, CRC, CRA, or related role; prior regulatory-focused experience preferred.
  • Hard-working self-starter that can thrive in an ambiguous environment. 
  • Preferred experience managing regulatory across a multi-site environment, including experience with digital ISF / CTMS / eTMF solutions.

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at TrialSpark. The target salary range for this role is $69,000 - $79,000.

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

If this range doesn’t match your expectations, please still apply because we may have something else for you.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Company

Formation Bio is a tech-driven pharma company differentiated by radically more efficient drug development. Formation Bio has built a technology platform that optimizes all aspects of drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data capture.

Formation Bio acquires clinical-stage drugs from pharma and biotech and develops them faster and more efficiently, unlocking greater value per program and accelerating access to new treatments for patients.

Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

Company info
Website
Phone
+1 510-545-3803
Location
16 East 34th Street floor 10
New York
NY
10016
US

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