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| Research Officer, Regulatory Affairs |
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| About the Organization |
| Name: |
Elizabeth Glaser Pediatric AIDS Foundation |
| Department: |
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| Industry: |
Non-Profit/NGO |
| Description: |
The Elizabeth Glaser Pediatric AIDS Foundation is a worldwide leader in the fight to prevent pediatric HIV infection and eradicate pediatric AIDS through research, advocacy, and prevention and treatment programs. We currently support programs for children and families in 18 countries around the world. The Foundation’s longstanding commitment to pediatric HIV/AIDS research is at the heart of what we do. Elizabeth Glaser created the Foundation at a time when there was no research dedicated specifically to meet the unique needs of children with HIV. We now support innovative projects, bringing the best minds together in collaboration and bridging gaps within the medical and research communities to ensure that children will have access to the best medical treatments. Only by working together can we continue to bring real solutions to children and families around the world and make real our vision that every child deserves a lifetime. |
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| About the Position |
| Internal Ref.: |
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| Job Type: |
Full-Time |
| Related Areas: |
International Health
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| Openings: |
1 |
| Location: |
Washington, DC (United States) | Map It! |
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| Description: |
Roles and Responsibilities:
• Serve as a central resource for regulatory and human subject issues for Foundation personnel conducting clinical, basic, and operations research in the US and internationally.
• Maintain essential documents/regulatory binders that will serve to demonstrate compliance with good clinical practice (GCP), regulatory, Foundation, and sponsor specific policies and procedures for international collaborative studies related to HIV infection in women and children.
• Assist in the regulatory oversight and coordination of Foundation multi-center, multi-country studies.
• Prior to the start of a Foundation research study, ensure all proper regulatory documents have been approved and that all documents, CRF, databases, monitoring/auditing requirements have been completed.
• Maintain detailed knowledge of all assigned protocols and ensure that the study personnel adhere to all protocol requirements to ensure the validity of the research data.
• Be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory file. Provide quality assurance of all essential documents maintained by the local personnel on site (e.g. source documents in participant files, laboratory documentation, participant consent forms). This may be accomplished through periodic site visits for review of these documents, close communication by conference calls and email with onsite personnel, and facilitation of training of onsite regulatory.
• Develop standard operating procedures (SOPs) for Foundation research activities and assist with the development of site SOPs; ensure that SOPs are maintained and available to staff as appropriate; coordinate and ensure review of applicable SOPs by staff on a timely basis; oversee benchmarking of SOPs.
• Assist with the process for site communication with local IRBs, including coordination of activities between all IRBs involved in a given protocol. Communicate regularly with site study personnel to ensure timely submission of annual renewals, study approvals, adverse event reports, and other correspondence.
• Identify and coordinate training for US and international staff that meets regulatory requirements, including human subjects research training and GCP training.
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| Compensation: |
No Response |
| Qualifications: |
• Nursing or BA/BS degree in health-related field.
• Minimum three years experience in clinical/operational research, regulatory affairs, and/or study monitoring. Experience with research in developing countries is a plus.
• In depth knowledge of Good Clinical Practices, ICH Guidelines, NIH, CDC, OHRP, and federal regulations for human subject participation in clinical research
Knowledge/Skills:
• French and/or Portuguese language skills preferred
• Must have excellent organizational skills, initiative, and be capable of functioning independently with minimal supervision.
• Excellent attention to detail and follow through.
• Knowledge of medical terminology and ability to follow multiple, detailed activities across a variety of protocols.
• Excellent interpersonal, oral, and written communication skills.
• Proven ability to work effectively as member of dynamic team in fast-paced environment
• Willingness and ability to travel internationally.
• Proficiency in computer software applications such as Word, Excel, and Powerpoint.
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| Start Date: |
ASAP |
| Other: |
No Response |
Posting available until Monday,
November 03, 2008
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| For more information, contact: |
| Name: |
Shelly Ammons
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| Address: |
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| E-mail: |
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| Web: |
http://www.pedaids.org |
| How to Apply: |
Please apply online at www.pedaids.org |
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