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| JOB TITLE: |
Clinical Information Specialist II |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Primary responsibilities include the receipt and abstraction of protocol and/or contact information into the appropriate databases for use by the client and their collaborators in support of clinical trials; respond to phone or email queries regarding standard processes associated with the abstractions; assist in the preparation of contract required reports; participate in the revision of SOPs and work instructions as necessary and appropriate; Handle special client requests as assigned; Other duties as assigned.
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| REQUIREMENTS: |
B.S. or B.A. degree (with 3+ years' work experience) or MS in health/science field. Relevant work experience such as regulatory affairs or clinical trials experience a plus. Excellent oral, written, interpersonal and organizational skills, Solid computer skills including database experience; experience using Microsoft Office; Scientific or medical background preferred. Exposure to GCPs and clinical trials a plus.
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| JOB TITLE: |
Human Subject Protection 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: |
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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| JOB TITLE: |
Regulatory Specialist II |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Prepare, distribute and track Investigational New Drug Applications (INDs); Prepare FDA required IND sponsor’s annual reports; Prepare scientific and other regulatory documents for submission to the Food and Drug Administration (FDA); Attend scientific meetings and reviews the literature to stay current with new developments in the infectious disease field (in particular, human immunodeficiency virus (HIV) and tuberculosis (TB)) and therapeutic clinical research; Preparation of investigator/pharmaceutical company meeting minutes; Perform literature searched and extraction of information to support regulatory documents; Participate in the revisions of SOPs and Work Instructions as necessary; Handle special client requests as assigned; Conduct high level quality control review of INDs and other regulatory documents to assure compliance with Food and Drug Administration requirements and guidelines; Train new staff on Regulatory processes; Other duties as assigned. |
| REQUIREMENTS: |
M.S. or Ph.D. or equivalent related experience in pharmacology, toxicology, biochemistry, molecular biology, immunology; 2-5 years regulatory or related work; Working knowledge of 21 CFR 312, Investigational New Drug Applications and other applicable FDA requirements and guidelines; Exposure to GCPs and clinical trials a plus; Excellent oral, written and interpersonal skills; Ability to analyze medical research data and review experimental protocols; Working knowledge of word processing, spreadsheet and database management programs. |
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| JOB TITLE: |
In-House CRA - ERDG |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Review and process essential regulatory documents received from clinical trial sites; request additional information when necessary; respond to protocol and process-related queries; maintain trail master files; and track the process in a centralized Web-based system and/or other databases. |
| REQUIREMENTS: |
Bachelor’s degree in life sciences or other health-related field; 0 - 2 years of experience in the clinical research arena; and proficiency with Microsoft Office. Experience with essential regulatory document review/collection and knowledge of applicable FDA ICH/GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO setting (i.e., CRA, Study Coordinator, IRB Coordinator, and Regulatory Coordinator/Associate/Specialist). BS degree in health-related field or Licensed Practical Nurse. Experience with IRB submissions (OHRP regulations) is a plus. |
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| JOB TITLE: |
HSP Team Lead |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Prepare and maintain Informed Consent Templates used to prepare Sample Informed Consents; Perform regulatory review of the protocol sample informed consent and the informed consent submitted by clinical sites; Prepare, update, and maintain lists of risks associated with study agents and with patient management guidelines for adverse events; Plan and conduct training sessions at national and international meetings on informed consents; Respond to international requests for implementation of non-US regulations for overseeing the IC process; Manage high level quality control review of informed consent to assure compliance with Food and Drug Administration requirements and guidelines; Manage the revisions of SOPs and Work Instructions as necessary; Manage special client requests as assigned; Train new staff on IC process; Other duties as assigned. |
| REQUIREMENTS: |
B.S. or M.S. degree or equivalent related work experience; Minimum of 5-8 years regulatory or related work experience; Ability to review clinical protocols; Working knowledge of 21 CFR 50, Protection of Human Subjects, 21 CFR 56, Institutional Review Boards, and 45 CFR 46, Protection of Human Subjects; Excellent oral, written, and interpersonal skills; Working knowledge of word processing, spreadsheet, and database management programs. |
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| JOB TITLE: |
Quality Assurance Compliance Specialist |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
Responsible for reviewing software validation and verification documentation to ensure compliance to applicable Standard Operating Procedures (SOPs) and regulations (21 CFR Part 11). They will also be responsible for verifying discrepancies are resolved and validation documentation is complete. Responsibilities may also include preparing standard operating procedures, training staff, assisting in client audits, assisting in external audits at vendor sites, and assisting in investigations. |
| REQUIREMENTS: |
BS/BA, Masters Degree desired but not required. 5-7 years of progressive QA validation experience. A solid understanding and working knowledge of GXP (minimum 5 years). Proficiency in MS Office. Travel ~ 5-10%. |
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| JOB TITLE: |
Regulatory Associate - RSC |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
This position will coordinate and attend Scientific Review Committee meetings, draft and distribute Scientific Review Committee Consensus memos and/or meeting minutes/action items and respond to process related queries via phone and email. Also, this individual will prepare or assist in the preparation of SOP's and contract reports. This position is part of a team supporting government sponsored clinical trials. |
| REQUIREMENTS: |
BS degree in a health related field with 1-2 years of experience (such as supporting IRB meetings) or a Master's Degree in Healthcare with 0-2 years of experience; proficiency in MS Office. Exposure to clinical trials a plus and medical background preferred. |
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| JOB TITLE: |
Safety & Pharmacovigilance Associate |
| STATUS: |
Full Time |
| DIVISION: |
Health |
| JOB DESCRIPTION: |
This position will manage and process SAEs; assist in the preparation of reports; generate specified data reports from the database; process and review investigator safety reports and notifications for non-IND adverse event reports; process and review safety narratives for IND and non-IND Adverse Event cases as required; maintain electronic files for the department; and query SAE databases. |
| REQUIREMENTS: |
Requirements include a B.A./B.S. degree in a relevant field, MS degree in related field a plus, 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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