Clinical Trial Associate ()

The Clinical Trial Associate (CTA) is a skilled specialist responsible for assisting and supporting the study team across investigator sites, contributing to the development of study concepts, techniques, and processes. With experience, the CTA takes on more complex tasks and applies effective solutions as needed. This role requires independent identification of tasks/issues and the ability to manage multiple responsibilities while adjusting to project or corporate priorities. The CTA may also perform limited monitoring responsibilities akin to those of a Clinical Research Associate.
 

• Execute study activities in line with study protocols, regulatory guidelines, and operational plans.

• Review study documents (IDB, protocols, CRFs, ICFs) to ensure thorough understanding of study drug and procedures.

• Maintain knowledge of SOPs, GCP, ICH guidelines, and regulatory standards.

• Participate in study start-up, conduct, and closeout activities.

• Coordinate and track activities from study inception through database lock, ensuring protocol and SOP compliance.

• Collaborate with functional areas and external providers to maintain high-quality study outcomes.

• Collect and review site regulatory documents (e.g., 1572, Financial Disclosures, CLIA waivers).

• Assemble and distribute regulatory binders to clinical sites.

• Assist in the preparation of trial-related documents, tools, and templates (e.g., start-up forms, screening scripts, source documents).

• Support project management activities by taking meeting minutes, preparing agendas, tracking enrollment, and maintaining study-status trackers.

• Help with preparation and distribution of investigator site contracts and budgets.

• Schedule and document study team and vendor meetings as needed.

• Track study documentation metrics and support invoice reviews from vendors/consultants.

• Assist in reviewing CRFs, study guides, reference binders, and forms, participating in EDC and IxRS specification processes.

• Support the planning of investigator meetings and/or site and CRA trainings.

• Oversee sample collection activities (e.g., tissue samples, lab samples, scans).

• Maintain and perform quality control of the Trial Master File for all clinical projects.

• Travel as needed to fulfill responsibilities and support study sites.
   

• Bachelor’s degree in biological sciences or related field (or equivalent experience).

• Excellent written and verbal communication skills.

• Proficiency in MS Word, Excel, and Project, with strong analytical and problem-solving abilities.

• Detail-oriented, with strong organizational and time management skills.

• Experience with Electronic Data Capture (EDC) systems and CTMS preferred.

Department: Direct Clients
This is a full time position