Job Information
Stemline Therapeutics, Inc. Clinical Trial Associate in NEW YORK, New York
- 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 of 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 ClinicalTrials.gov. * Supports preparation of Clinical Study Report and appendices as needed.## Qualifications * 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.