Note: The job is a remote job and is open to candidates in USA. ProSciento, Inc. operates a CRO division supporting clinical trials. The Clinical Trial Associate performs planning, execution, maintenance, and close-out activities for single- and multi-site clinical trials while supporting eTMF and CTMS systems under the direction of clinical management.
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
Skills
- 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
- Technical skill in clinical software such as CTMS is preferred
- Experience with clinical systems such as CTMS and eTMF preferred
Benefits
- Work remotely or in a hybrid arrangement based on approval from the department manager/supervisor
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