Clinical Protocol Developer - NIH - Bethesda, MD
Kelly Government Solutions - Bethesda, MD

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Clinical Protocol Developer
** NIH ** Bethesda, MD

***Seeking candidates with a clinical research background in stroke, neurology, acute care, and/or emergency medicine***

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Clinical Protocol Developer to work with the National Institutes of Health in Bethesda, MD.

This is a long-term contract position which offers:
- Competitive salary with comprehensive benefit package
- Free training and tremendous growth opportunity
- Opportunity to work at NIH, world's foremost medical research center
- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com

TASKS/SERVICES: The contractor shall:

(1) Coordinate with clinical staff to plan, prepare, implement, monitor and manage clinical protocols with Internal Review Board IRB requirements

(2) Provide expert guidance and assistance to clinical investigators in the writing, preparation and submission of protocols to the Investigational Review Board IRB, including initial submission, continuing review, amendments, audits, and other administrative requirements the formatting, preparation, and regulatory preparation of all protocols; helping investigators with consent writing

(3) Work with staff on protocol assembly, development and review of trial documents

(4) Evaluate, maintain and ensure compliance with regulations established for human subjects research at NIH in accordance with 45 CFR 46, the NIH Federal Wide Assurance FWA, and other applicable NIH and Department of Health and Human Services DHHS policies and procedures

(5) Maintain current knowledge of all policies and procedures specific to the safety issues for patients involved in research protocols as well as the regulatory aspects of data safety monitoring from a broad range of clinical disciplines to indentify, evaluate and interpret resource requirements for the support of biomedical research within NINDS; assist clinical investigators in obtaining a Certificate of Confidentiality when appropriate

(6) Evaluate, maintain and ensure compliance with regulations established for the use of investigational new drugs, 21 CFR 312 including preparation of the IND Investigational New Drug/Device application and submission to the FDA; assist with the writing of Safety Reports and annual FDA IND reports

(7) Actively protect and ensure safety of patients on research protocols, expected and unexpected adverse events; maintain extensive knowledge of guidelines for Good Clinical Practice and Code of Federal Regulations

(8) Assist clinical researchers with the preparation of Clinical Trial Agreements and Material Transfer Agreements

(9) Communicate with Principal Investigators (PIs), Associate Investigators (AIs), and Research Coordinators about all protocols within the research section from a broad range of clinical disciplines to identify, evaluate and interpret resource requirements for the support of biomedical research

(10) Develop and maintain collaborative relationships with members of other health care disciplines such as physicians, nurses, laboratory, pharmacists and consultants

(11) Maintain accurate records of all protocols and IND applications, safety reports, annual reports, and correspondence

(12) Oversee the collection, distribution and filing of regulatory documents

(13) Create databases and coordinate data collection

(14) Assist in the preparation of adverse event files and reports; ensure timely and accurate evaluation and reporting of adverse events in accordance with IRB, FDA and DSMB policies

(15) Keep abreast of latest developments in human subjects research regulations and bioethics policies

REQUIREMENTS: The contractor must have:

(1) Minimum of BA or BS degree with preference for a Master's degree or Ph.D. in a related field

(2) CCRP or equivalent certification preferred

(3) Experience with clinical trials involving stroke, neurology, or emergency medicine preferred

(4) Minimum of six (6) years of experience in protocol development/coordination

(5) Expert knowledge of the rules and regulations concerning participation and protection of human subjects in research trials and/or acquisition of such through additional training

(6) Knowledge of study design methodology, data analysis and interpretation of results needed to carry out complex studies

(7) Experience with meeting IRB requirements

(8) Extensive knowledge of guidelines for Good Clinical Practice and Code of Federal Regulations

(9) Strong interpersonal skills in order to deal effectively and persuasively with a wide range of audiences, ranging from researchers to lay groups

(10) Excellent analytical and writing skills to prepare a variety of responses, meeting materials, technical, and administrative correspondence and reports

(11) Strong organizational skills and the ability to prioritize complex tasks

(12) Strong computer skills and experience with protocol management systems

PLEASE APPLY ONLINE

Please visit www.kellycareernetwork.com to apply for this position. Due to the volume of inquiries, we regret that we cannot accept phone calls. Please also note that the phone number for our NIH branch is not listed.

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