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.

• Act 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.
• Assist the clinical trial team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the standard operating procedures.
• Assist with the maintenance of trial-specific tracking reports (e.g. patient enrollment, regulatory documents, site visits, Adverse Event (AE/SAE), Protocol deviations).
• Support the clinical trial team(s) in updating reports and management plans.
• Assist 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.
• Maintain trial specific training records, including preparation of the trial team list. Collaborate with Quality Assurance to ensure all appropriate team members are trained on trial specific plans and documents.
• Coordinate with trial vendors throughout the clinical trial lifecycle and maintain vendor list.
• Participate in company improvement initiatives.
• Assist 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.
• Provide updates on clinical trial status on Clinical Trials.gov.
• Support 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, gender identity, national origin, disability, or status as a protected veteran.

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to…