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| JOB TITLE: |
Attorney/Clinical Trials Agreement Advisor |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Draft and negotiate Clinical Trial Agreements and other research agreements between the government client (National Institutes of Health) and industry collaborators (biologic and drug product manufacturers) and provide counsel on FDA laws and regulations, contracts, intellectual property, access to data, ownership of data and specimens, safety reporting, patient privacy, liability, indemnification, confidentiality, and human subject protection. The main focus of the position will be on government sponsored HIV/AIDS clinical research.
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| REQUIREMENTS: |
JD from accredited law school with excellent academics, member of the Bar of any state, a minimum of two years of relevant experience, excellent verbal and written communication skills, precise drafting and accurate legal research skills, and knowledge of the regulations and statute impacting clinical trials research.
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| JOB TITLE: |
HSP Specialist II |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Responsible for conducting reviews of domestic and international sample and site-specific informed consent documents for compliance with applicable federal regulations and policies; providing expertise on the implementation of relevant Human Subjects Protection regulations.
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| REQUIREMENTS: |
Requirements include a relevant Master’s Degree or PhD with 2 to 3 years experience in bioethics or a clinical research environment, and excellent writing and interpersonal skills. The ideal candidate will have a working knowledge of the Common Rule and other regulations/policies relevant to the protection of human subjects. Bioethics, CRA, infectious disease, experience working with HIV patients, and/or regulatory experience a plus.
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| JOB TITLE: |
Quality Assurance Specialist I |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Promotes Quality by preparing Standard Operating Procedures, providing training to staff and supporting the Quality Management System. Provides administrative support within TrackWise by maintaining staff within the system. Responsibilities may also include assisting in client audits, conducting external audits and vendor sites, as well as reviewing CAPA, deviations, and clinical quality management plans.
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| REQUIREMENTS: |
1-3 years of QA experience preferably in a CRO environment. A good understanding and working knowledge of GCP. Experience working with Quality Management Systems. Proficiency in MS Office. Travel up to 5-10%.
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| JOB TITLE: |
Regulatory Specialist |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Prepares scientific and regulatory documents (e.g. clinical protocols, investigator’s brochures, informed consent forms, annual reports, investigational new drug applications, regulatory correspondence, and clinical summary reports). Prepares investigator/pharmaceutical company meeting minutes, analyzes preclinical and clinical data, prepares reports, performs literature searches and extracts information to support regulatory documents.
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| REQUIREMENTS: |
M.S. degree or equivalent with 5 or more years of relevant work experience or a Ph.D. with 1 or more years of relevant work experience in pharmacology, toxicology, biochemistry, molecular biology, immunology, or a related field.
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| JOB TITLE: |
Safety & Pharmacovigilance Associate |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Tracks and amends adverse event reports; abstracts key adverse events into databases; prepares and reviews investigator safety reports and notifications for non-IND adverse event reports; maintain electronic files for the department; and query SAE databases.
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| REQUIREMENTS: |
Requirements include a B.A./B.S. degree in a relevant field, 0-5 years of pharmaceutical, biologics, and/or diagnostic experience, as well as excellent oral, written, and computer skills including database experience. Experience with medical terminology is preferred.
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| JOB TITLE: |
Safety & Pharmacovigilance Specialist |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Perform various tasks in support of cancer clinical research including monitoring the clinical site phone and email hotlines, reviewing/triaging adverse events, preparation of safety reports, safety analyses, and clinical site support.
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| REQUIREMENTS: |
MD, RN, or PharmD, 1-2 years of related work experience, knowledge of CTC and/or MedDRA coding, and Good Clinical Practices. Must have excellent oral, written, presentation and computer skills. Experience with Serious Adverse Events.
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