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.
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
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.