Senior Clinical Trial Associate

Crinetics Pharmaceuticals•Headquarters, KY

2d•Onsite

About The Position

The Senior Clinical Trial Associate (CTA) is a highly skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and helping lead the study team across all investigator sites. Based on experience, the Senior CTA assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the Senior CTA independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities. The Senior CTA may act as a Clinical Research Associate with limited monitoring responsibilities.

Requirements

Bachelor’s degree biological sciences or related discipline with a minimum of 2 years of clinical experience (an equivalent combination of experience and education may be considered)
Excellent written and verbal communication skills
Strong PC skills (MS Word, MS Excel, MS Project)
Sound analytical and problem-solving skills
Act with consistent sense of urgency with acute attention to detail.
Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
Exceptional organizational and time management skills

Nice To Haves

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed.

Responsibilities

Execute study activities independently according to study protocol, regulatory guidelines and operational plan
Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
Contribute to study start-up, conduct, and close-out activities including, but not limited to, create patient facing materials, draft newsletters and site memos, track study metrics and escalate issues to study team
Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
Participate in vendor management activities by tracking performance and quality
Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
Assemble and distribute regulatory binders to clinical sites
Draft trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers
Assist with preparation and distribution of investigator site contracts and budgets
Schedule, set up, and minute study team and vendor meetings, as applicable
Maintain metrics on results of study documentation reviews
Support the review of invoices from vendors/consultants as needed
Support the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT
Support the planning of Investigator Meetings and/or Site and CRA trainings
Manage the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples)
Lead the Trial Master File activities to ensure quality and completeness for clinical projects
Manage and perform periodic reviews and QC of the Trial Master File
Travel as required to carry out responsibilities
Other duties as assigned