Clinical Trial Assistant

Job Title: Clinical Trial Administrator Location: Boston Job Description The CTA (Clinical Trial Assistant) is an experienced or associate level (junior level) position responsible for performing a variety of research, database, and clerical duties of a complex and technical nature in support of multiple clinical trials. This position also provides administrative support to clinical teams by reviewing vendor invoices for accuracy against budget, tracking vendor payments in compliance with federal regulations and taking meeting minutes during project team meetings. Key Responsibilities Overall responsibility of Trial Master File (TMF): set up, maintenance and archiving for in-sourced or outsourced studies For outsourced studies, controls administrative work ensuring CRO maintains a complete trial master file and 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 Ensures consistency and setup between all outsourced studies to our TMF structure Assist in study set‑up activities (regulatory binders, investigator meetings, presentations, CDAs, agreements, insurance, etc.) Serve 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 or delegated CRA Process invoices and investigator payments after appropriate approval obtained by Clinical Project Manager Assemble final report appendices; ensure final report completeness in collaboration with Clinical team Work on a Global Project Team and interface with Europe and Global counterparts, as needed Responsible for setup of public registries and maintenance Other duties as assigned Preferred Skills And Qualifications Bachelor’s Degree in a related field, or equivalent combination of training, education and work experience, required Three (3) or more years of experience in a clinical administrative or regulatory role in a pharmaceutical or CRO environment One or more years of experience in a Clinical Trial Assistant role Previous administrative work experience, preferably in an international clinical research setting Knowledge of FDA GCP‑ICH Guidelines and local regulatory requirements Ability to demonstrate a high level of competency relating to administrative and clerical responsibilities, procedures, and systems Ability to handle confidential information and materials in an appropriate manner, and in accordance with organizational policy, proper business practice, and/or appropriate external regulation/governance Ability to work within a team environment and to clearly communicate with others (internal and external customers) Excellent communication (verbal/ written), interpersonal, and organizational/time‑management skills Self‑motivated, quick to learn, proactive and flexible What We Offer In Return You will be working for an organization that embraces diversity & inclusion and believes we will deliver better outcomes by reflecting the perspectives of our diverse customer base. Employer’s Rights This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. #J-18808-Ljbffr