Research Protocol Specialist 9/16/2016
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Decypher is a leading integrator of professional, technology, and management solutions and services. We provide our services globally to Federal, Commercial, Local and State clients. Our employees are our most valuable asset and play an integral role in the success of Decypher and our clients. Working at Decypher is not a job, but a career where your talent and energy is respected and you can personally make a difference. Decypher invites you to join our professional team. Decypher is an equal opportunity/affirmative action employer committed to diversifying its workforce (M/F/D/V).
Decypher is seeking Research Protocol Specialist candidates to support Walter Reed National Military Medical Center, located at Bethesda Maryland.
* Orchestrates meetings and collaborates with principal investigators, physicians, scientists, nurses, and other professional disciplines to identify required support for research projects, working directly with researchers and study team members on the development, production, revision, and evaluation of clinical research protocols and Informed Consent Forms (ICFs) facilitating the activities of writing and regulatory review with bi-directional dialogue and feedback. Participates with the Principal Investigator in the scientific design of research protocols and makes recommendation on methodology.
* Analyzes the role and impact of other auxiliary departments on the proposed research and coordinates their input. Evaluates research protocols for compliance with applicable regulations governing human subject s protection. Assures the proper documentation of project/study, giving particular attention to any protocol modifications.
* Assists the research study team with Investigational New Drug (IND)/Investigational Device Exemption (IDE) status determinations and supports the research staff in navigating requirements for special circumstances (vulnerable populations, multisite projects, etc.). Coordinates with investigators and other designees to ensure Institutional Review Board (IRB) stipulations are appropriately addressed in a timely manner by providing expert knowledge and advice regarding regulatory requirements.
* Reviews protocols for completeness, accuracy and compliance with all DoD, FDA and DHHS regulatory requirements and guides protocols through various committees until approval is achieved. Review ensures that objectives of the proposed study are clear-cut, guiding the application of conventional methods and research techniques to new, unexplored topics.
* Provides consultation and assistance to complete research protocol lifecycle requirements e.g., continuing review applications, protocol amendments, applicable Data Safety Monitoring Board (DSMB) reviews. Works with IRB office to ensure submissions are complete and DSMB or other safety reviews are scheduled in a timely manner. Serves as a resource for and consultant to Principal Investigators, research coordinators, and other Research Review Service staff, as necessary. Independently prepares lectures and conducts on-the-job training on protocol review and coordination for new employees.
* Participates in staff development, in-service and professional continuing education programs.
* Facilitates access to services and the process to obtain required approvals to initiate research projects by coordinating the submission of additional regulatory and logistical requirements with applicable staff (e.g., ORTA, Radiation Safety Committee, IBC, etc.) and data management, if needed. Ensures that protocols explain how patients are monitored for adverse reactions to medications, medical/surgical procedures and any other outcomes which pose a threat to the subject.
* Four (4)-year college degree in Allied Health Care.
* Clearance: NACI
* Must be US Citizen
* Three (3) years of working experience.