Galderma Laboratories, LP
Clinical Trial Administrator (R&D)
The Clinical Trial Administrator (CTA) administers, maintains and coordinates the logistical aspect of clinical trials, according to GCP (good clinical practice) guidelines and relevant SOP's (standard operating procedures). The CTA acts as a main point of contact for the clinical trial team and the study site staff and coordinates the overall management of clinical trial documentation within a clinical program. Ensures proper collection, filing, tracking and storage of clinical trial documentation in support and at the direction of the Clinical Project Manager (CPM) Transfers clinical documentation to regulatory for regulatory filings Collaborates with the Clinical Research Associates (CRAs) and Clinical Project Manager (CPM) during clinical research hard copy and e-documentation process Calculates investigator fees in accordance with contractual agreements Overall responsibility of Trial Master File (TMF): set up, maintenance & archiving for in-sourced or outsourced studies - Controls administrative work ensuring CRO maintains a complete trial master file & organized shipment to Galderma in the appropriate format at the end of the study - For in-sourced studies assures filing on an ongoing basis of a complete TMF (including insurance, translations, approvals, etc.) - Completes TMF Quality Control and subsequent Quality Assurance audit resolution including drug reconciliation documentation in collaboration with clinical team; Assures administrative archiving of the TMF - E-filing of essential documents in Documentum - E-filing of internal metric in appropriate tool - Assists in study start-up: Regulatory binders, investigator recruitment tasks, investigator meetings, presentations, etc. Collects, controls and submits initial and subsequent regulatory documents to IECs (including protocol and amendments) and, collaborate with Regulatory group Obtains signatures necessary for the conduct of the trial, from drug release through final archive Serves as the contact and/or liaison for the CRO and Investigative sites for regulatory documents, clinical supplies, CRFs, study agreement (financial contract), and other pertinent administrative matters under the supervision of the CPM Follow the study budget closely and keep the CPM informed. Process invoices and Investigator payments after appropriate approval obtained Assembles final report appendices and ensure final report completeness in collaboration with clinical team Organizes and conduct formal presentations at meetings and training sessions, as applicable On an as needed basis, may help the team with writing of some clinical documents Assists with training and mentoring new CTAs a. Identification of needs b. Provide training c. Provide clear feedback to Manager on progress Performs other duties assigned by Management Travel & Residency Fort Worth, TX
-Minimum of 2 - 5 years of relevant clinical trial administration experience is required. Drug/device combination and biologics experience preferred - Good command of MS Office applications and ability to learn and to adapt to work with IT systems - High degree of analytical thinking, the ability to critical reasoning, effective planning and organizational skills with result oriented approach