New York, NY
Industry: Hospitals & Medical Centers•
Less than 5 years
Posted 60 days ago
As the Clinical Research Manager of the GU Biorepository program, you will coordinate and manage multiple clinical trial projects and protocols, including federally funded studies, investigator-initiated studies, and/or those from pharmaceutical companies. The manager will instructs and trains staff regarding the requirements for all protocols; provides support for ongoing research projects and provides administrative oversight and guidance regarding staff roles and regulatory submissions for each study. This position reports into the Executive Director of Clinical Research Administration within the Tisch Cancer Institute and the Medical Directors of the MPD Program. Duties and responsibilities:
Duties and Responsibilities:
1. Manages and coordinates clinical trial and related research studies conducted by the principal investigator(s) to ensure conformance with specified research objectives and protocols.
2. Coordinates and establishes clinical trial schedules, task assignments and allocation of staff.
3. Oversees the status of all subjects enrolled in clinical trials, including completion and tracking of all required regulatory documents, including the appropriate reporting of all SAEs.
4. Ensures clinical research studies are conducted according to good clinical practices, specified research protocols, and requirements of the Icahn School of Medicine at Mount Sinai, outside sponsors and all federal and/or state regulatory agencies.
5. Serves as the primary liaison with pharmaceutical companies for industry-sponsored clinical trials. Provides updates on status, adverse side effects and trends, evaluates patient enrollment and provides appropriate recommendations and/or conclusions.
6. May play a role in monitoring and reconciling budget and other financial items for clinical trials and tracking reimbursements from sponsoring parties.
7. Develops policies and procedures for administrative oversight of clinical trials; conducts regular meetings with staff to ensure compliance with established practices and to keep employees abreast of current standards and policies.
8. Organizes grant submissions and implements standard operating procedures for clinical monitoring. Manages and monitors all sites involved in multi-site clinical trials which the principal investigator is responsible for including recruitment and management of subject enrollment.
9. Assists with various personnel functions such as hiring, performance appraisals, coaching, disciplinary actions and terminations. Provides guidance and support to staff and orients and mentors new research team members.
10. Assist with the coordination of the MPD Consortium, a NCI-sponsored program of 35 institutions in the United States and Europe, of which Mount Sinai is the lead site. The consortium focuses on understanding the biological foundations of the myeloproliferative neoplasms and using that understanding to develop hypothesis-generated therapeutic trials to improve the therapy of patients.
11. Assist Investigator(s) with developing IITs multi-institutional consortium set up to coordinate, facilitate, and perform basic and clinical research.
12. Support the logical operations of the liquid tumor tissue bank(s).
13. Performs other related duties, as appropriate.
Bachelor's Degree in Biology, Public Health or related scientific/health field; Masters preferred
• 4 years of experience managing clinical trials
• At least 1 year experience in a management/leadership role
• Excellent written, oral and interpersonal skills
• Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance
• Proven ability to provide scientific and clinical expertise in all phases of clinical trials
• Excellent analytical and problem solving skills
• Strong management and leadership skills
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