Clin Rsrch Implementation Spec
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POST DATE 8/14/2016
END DATE 11/12/2016
Hackensack University Medical Center
JOB DESCRIPTIONThe Clin Rsrch Implementation Spec serves a resource to the investigators on all matters relating to the design, conduct, and implementation of clinical research. This role serves as the local subject matter expert for the development of investigator initiated research. This includes offering assistance with participant safety and regulatory issues, recruitment and retention of subjects, data and safety monitoring plans, and ensuring the study design is in accordance with all applicable federal regulatory policies and guidelines. S/he works in accordance with the policies of Hackensack UMC Human Research Protection Program on compliance and achievement of the goals related to the expansion of the clinical research enterprise. This is a service position that will interface with both administration as well as principle investigators and their research teams. 1. Educates investigators regarding the requirements for Investigational New Drug Applications (INDs) and roles of IND-Sponsors and Investigators. 2. Assists with the development of investigator initiated protocols and other required documents. 3. Assists investigator-sponsors in the preparation and submission of IND related materials, as requested. 4. Identifies service improvement opportunities that will reduce or eliminate barriers to research as experienced or perceived by research community. 5. Serves as the institutional liaison to the FDA, other regulatory agencies and Sponsors to facilitate investigator-initiated research development. 6. Creates system to track IND milestones and generates reminders to aid in compliance with FDA reporting requirements. 7. Creates and supports web-based resources and guidance for investigators and Sponsor-Investigators of INDs. 8. Facilitates communication between investigators and the Office of Research Administration. 9. Provides consultation on implementation and management of investigator-initiated clinical trials. 10. Develops and applies quality assurance practices for domains of work in collaboration with the Manager. 11. Maintains strong lines of communication with Ancillary Departments and outside Vendors to facilitate the growth of the research enterprise. 12. Adheres to Standards identified in the Medical Center's Organizational Competencies. Working Conditions: Lifts a minimum of 5 lbs., push and pull a minimum of 10 lbs. and stand a minimum of 4 hours a day. Education, Knowledge, Skills and Abilities Required: 1. Bachelor's degree. 2. 0 - 2 years of experience in clinical research. 3. Advanced Microsoft Office Skills (Excel). 4. Ability to analyze complex situations, identify solutions, and make appropriate determinations. 5. Ability to work effectively as a member of a team. 6. Excellent written and verbal communication skills; excellent interpersonal skills; writing sample required. 7. Must possess strong analytical skills consistent with the development of clinical trials. Education, Knowledge, Skills and Abilities Preferred: 1. Prior experience with FDA preferred. 2. Familiarity with CTMS and electronic regulatory submissions. Licenses and Certifications Required: Licenses and Certifications Preferred:
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.