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Regulatory Compliance Coordinator
Full/Part Time: Full Time
Location/Affiliates: Mount Sinai Medical Center (Manhattan)
Department: 821 - Cardiology
Requisition Number: 13-1584798
The Regulatory Coordinator is under the supervision of the Research Regulatory Compliance Manager. The Regulatory Coordinator will assist the Regulatory Manager and clinical study teams in the start-up and management of clinical studies including, but not limited to, regulatory document processing and database management. Duties include but are not limited to: maintaining central regulatory files, tracking systems, obtaining signatures and providing ad hoc reports.
1. Ability to verbally communicate effectively with physicians, pharmaceutical company representatives , IRB staff and other clinical research team members. Ability to communicate effectively by e-mail and letters.
2. Ability to analyze information and solve problems relating to information gleaned from Case Report Forms and written clinical reports. The regulatory coordinator will be involved in the initiating, implementation and assist with monitoring of the clinical trial process.
3. Strong focus on teamwork, attention to detail, excellent organizational and planning skills. Must have ability to prioritize, have excellent communication skills, and the ability to work in a busy office environment.
4. Maintains liaison with staff in other departments to coordinate research activities to accomplish program objectives and to ensure cooperative efforts are enhanced and available resources are utilized.
5. Assists in efforts to streamline work processes to increase the effectiveness and efficiency of the program.
6. Performs other related duties.
Bachelor's Degree and up to two years experience in the clinical research setting or equivalent in education, training and experience.
Excellent written and oral communication skills
Excellent organizational skills and the ability to prioritize multiple tasks, projects and assignments
Proficient with Microsoft Word, Excel.
Exceptional attention to detail and accuracy.
Training in GCP, and HIPAA regulations will be required.
Mount Sinai Medical Center is an equal opportunity/affirmative action employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds. Mount Sinai Medical Center--An EEO/AA-D/V Employer.