Clinical Trial Associate

Overview

Reporting to the Clinical Program/Trial Lead, the Clinical Trial Associate will provide clinical operational support to Clinical Trial Teams throughout the lifecycle of clinical trials. Responsibilities include assisting with the start-up, execution, and close-out phases. Success in this position relies on attention to detail, strategic planning, and meticulous follow-through.

Acts as a central point of contact for the clinical trial team for designated project communications, correspondence, and associated documentation.

• Ownership and maintenance of trial SharePoint site.
• Ownership of electronic Trial Master File (eTMF) and maintenance of eTMF set up, organize, and maintain clinical study documentation (e.g. Trial Master File documents, email correspondence, training materials, etc.) including preparation for internal/external audits, periodic and final quality review and archival.
• Coordinate internal and external meeting agendas and minutes, as applicable. Responsible for preparing and distributing Clinical Trial Team (CTT) meeting agenda and capturing CTT meeting minutes.
• Assists the clinical trial team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the standard operating procedures.
• Assists with the maintenance of trial‑specific tracking reports (e.g. patient enrollment, regulatory documents, site visits, Adverse Event (AE/SAE), Protocol deviations).
• Supports the clinical trial team(s) in updating reports and management plans.
• Assists in the resolution of issues, questions, and process requests for additional study supplies.
• May participate and support responses to Quality Assurance and/or regulatory authority inspection audits and always maintain inspection readiness.
• Maintains trial specific training records, including preparation of the trial team list. Collaborates with Quality Assurance to ensure all appropriate team members are trained on trial specific plans and documents.
• Coordinates with trial vendors throughout the clinical trial lifecycle and maintains vendor list.
• Participates in company improvement initiatives.
• Assists in coordinating Investigator and third‑party payments.
• Act as a backup for other Clinical Trial Associates (CTAs) as needed.
• Can serve as a Clinical Operations Representative.
• Provides updates on clinical trial status on Clinical Trials.gov.
• Supports preparation of Clinical Study Report and appendices as needed.

• Minimum 2 years in a clinical research environment.
• Experience in oncology is required.
• B.A./B.S. in life sciences or equivalent experience.
• Knowledge of clinical trial regulations, guidelines, and best practices, including ICH‑GCP and FDA requirements.
• Experience utilizing various eTMF platforms.
• Possess strong interpersonal, organizational, written and oral communication skills, and must be detail‑oriented.
• Work independently to prioritize tasks and manage multiple projects while operating under tight deadlines.
• Capable of developing complex reports and meticulously tracking administrative documents, including correspondence.
• Handle sensitive and confidential information with the utmost discretion.
• Collaborate across different organizations and work as part of a team to support departmental initiatives
• Proficient in Microsoft Suite/Office, Adobe Acrobat, and Smartsheet.

Please note: this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Base Salary Range of $115,000-$155,000. Menarini Stemline offers generous compensation and benefits packages, including Short-Term Incentive Programs, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre‑tax FSA/HSA programs.

Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation,…