Clinical Trial Associate

| Greater NYC Area | Remote | Hybrid
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About TrialSpark

TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.

The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.

TrialSpark recently raised their Series C, and is putting the capital to work by  in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.

Position Overview

TrialSpark is seeking a Clinical Trial Associate to play a key role on a highly dynamic cross-functional team. You will be responsible for administrative support in the advancement of clinical trials as part of TrialSpark’s Clinical Operations team from study start-up to study closure.

We need you to have awareness of applicable clinical research regulatory requirements - ICH GCP. You should be able to demonstrate a willingness to work in a fast-paced environment juggling workload with time pressures. The ability to establish and maintain effective working relationships with coworkers, managers, and clients is key and you should have good written and verbal communication skills as well as working knowledge of computer applications such as Word, Excel, and PowerPoint.

Duties and Responsibilities

Duties include but are not limited to: 

  • In collaboration with Clinical Project Managers, support the study operational strategies.
  • Process clinical study documentation in accordance with SOPs, FDA, and ICH GCP guidelines.
  • Develop meeting agendas, minutes and track follow-up actions
  • Maintain a vendor and site contact list
  • Maintain study operational data in the CTMS
  • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
  • Prepare, handle, distribute, file, and archive clinical documentation and reports
  • Assembles and prepares distribution of site binders
  • Perform administrative tasks to support team members with clinical trial execution as needed
  • With oversight from the Director, Clinical Project Management, provide support to the multifunctional team on special initiatives as needed.
  • Create and improve upon business processes that ensure TrialSpark’s successful growth

About you

Skills, abilities, and knowledge

  • Understanding of clinical trial operations and management of clinical trials at investigator sites
  • Multitasking ability to oversee a large number of projects and reach milestones on time
  • Exceptional academic and professional accomplishments, indicating critical thinking ability
  • Strong written and oral communication skills with incredible attention to detail
  • Willingness to roll up your sleeves and get in the weeds of projects as a jack of all trades
  • Ability to think outside of the box and challenge the status quo
  • Desire to work in a fast-paced, innovative environment
  • Natural collaborator who enjoys working on a cross-functional team

Required education and experience

  • BA/BS in a clinical or scientific discipline; at least 2 years of experience with clinical trials; working with a sponsor company (biotech/pharmaceutical company)
  • Additional experience in other related fields or positions, some phase 2/3 and global clinical trial experience is a plus.
  • Understanding of FDA, EMEA, ICH and GCP guidelines, as well as cross-functional clinical processes including clinical supply, data management, and drug safety.
  • Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent.

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.

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Technology we use

  • Engineering
  • Product
  • People Operations
    • JavascriptLanguages
    • PythonLanguages
    • ReactLibraries
    • ReduxLibraries
    • FlaskFrameworks
    • PostgreSQLDatabases
    • LookerAnalytics
    • FigmaDesign
    • MiroDesign
    • ConfluenceManagement
    • Google DriveManagement
    • Google DocsManagement
    • JIRAManagement
    • SlackCollaboration
    • ZoomCollaboration

Location

Our office is located in Manhattan, near the Empire State Building. The area is lively and has great food and transportation options!

An Insider's view of Formation Bio

What’s the vibe like in the office?

The space is very open which makes it easy to collaborate and engage with different teams across the organization. People are very welcoming, supportive, and friendly. There is always a variety of different food and drinks available in the kitchen, in addition to foods that co-workers bring in for everyone to taste!

Joseph Frappaolo

IT Support Technician

What projects are you most excited about?

The project that excites me most is our new hire onboarding program because of the impact it will have on our company. Though we have a robust onboarding program in place already, we have the opportunity to think creatively about how to make the experience even better for our new hires, from the moment they accept our offer.

Erin Siegel

Senior People Operations Manager

How has your career grown since starting at the company?

I started working at Formation Bio in July of 2018. I joined the company as a Clinical Research Coordinator and was allowed to grow and adapt into new roles as the company's business model shifted. I transitioned into working as a Clinical Trial Associate after a couple of years, and now have over a year of experience as a Clinical Project Manager!

Gurpreet Singh

Clinical Project Manager

How has your career grown since starting at the company?

Formation Bio has given me the opportunity to take ownership over big projects and work streams, allowing me to have an impact on key functional business areas.

Maya Dongier

Senior Accounting Manager

What are Formation Bio Perks + Benefits

Formation Bio Benefits Overview

Formation Bio is nothing without its employees, so they are well taken care of! We offer comprehensive benefits that span from insurance to 401ks, with added perks like a pet-friendly office. Come meet our office dog, Rosie!

Culture
Open door policy
Open office floor plan
Employee resource groups
Hybrid work model
Flexible work schedule
Diversity
Mandated unconscious bias training
Diversity employee resource groups
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental insurance
Vision insurance
Health insurance
Life insurance
Financial & Retirement
401(K)
Company equity
Pay transparency
Child Care & Parental Leave Benefits
Generous parental leave
Vacation & Time Off Benefits
Unlimited vacation policy
Paid holidays
Paid sick days
Office Perks
Company-sponsored outings
Yearly retreat and holiday party, regular team events and outings!
Free snacks and drinks
Company-sponsored happy hours
Fitness stipend
Home-office stipend for remote employees
Mother's room
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Continuing education stipend
Virtual coaching services

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