Clinical Trial Associate
About The Position
The Clinical Trial Associate (CTA) will perform activities related to the planning, execution, and delivery of single and multi-site clinical trials in ProSciento’s CRO division, under the direction of the Clinical Team Manager (CTM) and the Study Startup Manager (SSUM). The CTA will also function as a subject matter expert for the electronic Trial Master File (eTMF) and Clinical Trial Management (CTMS) system. This position will require an understanding of the basic skills necessary for the application of regulatory requirements, ICH/GCP guidelines, and CRO level methodologies. The CTA performs duties in accordance with company’s values, policies, and procedures.
Requirements
- Familiarity with Good Clinical Practices (GCP), ICH guidelines and FDA regulations is preferred.
- Bachelor’s degree in health, biological science, or other related field and 1-year related experience in clinical research or other comparable combination of education, training, and experience.
- Basic knowledge and understanding of CRO clinical systems and procedures.
- Basic knowledge and understanding of applicable regulatory regulations.
- Working knowledge of clinical research; ICF review; IRB submissions; regulatory review/submissions; clinical site oversight; protocol review; and use of clinical systems.
- Good communication skills, both verbal and written.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Knowledge of MS Office software.
Nice To Haves
- Technical skill in clinical software such as CTMS is preferred.
- Experience with clinical systems such as CTMS and eTMF preferred.
Responsibilities
- Manages the CDA execution process with sites and coordinate the Feasibility Questionnaire process
- Assists with the selection of investigators
- Provides study-specific details for the CTMS system set-up
- Delivers Regulatory Packet and trial-specific documentation
- Collects site essential documents for activation
- Compiles the package of documents for IEC/IRB and forwards to either the investigator or IEC/IRB as directed (throughout the entire study)
- Performs the first review of the Essential Document Packet and completes the SIV Authorization Form
- Populates and updates the Contact List in CTMS
- Prepares and ships Regulatory Binders to sites
- Coordinate initial shipment of lab kits, IP, and supplies to sites
- Ensures all documents for eTMF upload are in correct location, named and labeled appropriately upon site activation
- Participates in the SSU-to-Clinical Operations handover process
- Responsible for collection of site-specific documents, including filing of documents in accordance with ProSciento’s SOPs
- Performs central monitoring activities in collaboration with the site CRAs
- Reviews, maintains, and monitors lab kit supplies/inventory at the sites
- Tracks IP shipments and ensures adequate delivery timelines
- Contacts sites and vendors to facilitate the resolution of queries and data discrepancies
- Performs other Clinical or Site Management activities at the direction of the study CTM/PM
- Ensures all site trial eTMF documentation is collected
- Performs the final site contact list reconciliation for trial
- Assists in the reconciliation of study supplies and document collection
- Assists in protocol deviation and vendor query reconciliation
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
