Nimbus has an outstanding opportunity for an exceptional Clinical Trial Associate to join our team. The person in this role will assist and support the Clinical Operations Lead/Study Manager and the study conduct team in the execution of clinical study(ies) conduct to support project team goals and objectives. The scope of this position may support multiple studies.
In this role, you will:
- Support the day-to-day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines and other regulatory requirements.
- Activities may include: tracking of appropriate subject and site activity/metrics, performing quality check activities across components of the clinical study, etc.
- Proactively identify and escalate issues that arise related to support functional deliverables.
- Assist in study set-up including but not limited to protocol/synopsis preparation, informed consent form preparation and review, systems (i.e., CTMS, IRT, etc.), study operational manuals, training manuals, investigator document review, various study plans (i.e., visit logs, drug inventory, monitoring plans, etc), and other study-related requests.
- Collaborate with CRO on the timely collection and archiving of TMF documents for assigned studies/programs. Coordinate with regulatory on the ongoing submission of essential documents to regulatory authorities.
- Assist in the management of study completion activities with the CRO and the sites including TMF reconciliation, drug reconciliation, ensure that all documents are available for the CSR.
- Effectively communicate with study team members and work closely with Clinical Operations Lead/Study Manager.
- May participate in process improvement and quality-related initiatives associated with study execution and deliverables.
- Other duties as assigned.
These Qualifications Will Help This Role Be Successful:
- Associate degree with at least 2 years of experience in the healthcare field or at least 5 years of direct clinical trial-related experience
- Strong Organizational Skills
- Must have excellent interpersonal, written, verbal communication, computer, and administrative skills
- Computer ability
- Minimal travel required (0 to 5%)
- General knowledge of drug development and ICH/GCP
- Pharmaceutical/Biotechnology Industry Experience
A Snapshot of Nimbus
At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success, we’ve built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.
Nimbus is a close-knit company (our employees are Nimbi, if you are curious!) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.
Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Cambridge, Massachusetts. Learn more about us by going to www.nimbustx.com
Join Nimbus. We are making a difference and you can too.
Nimbus is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.