Attachment G - Labor Categories Minimum Qualifications Sample Task Order.docx
DOCX document 26 KB Posted
- Attached to
- Post-Market Bioequivalence (BE) Studies
- Solicitation number
- FDAFO121683-Amendment
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This document is an Attachment containing Labor Categories and Minimum Qualifications for a clinical research task order. The attachment specifies three critical labor categories with detailed qualification requirements: Principle Investigator (PI), Bioanalytical Scientist, and Study Coordinator. Each role has specific educational, certification, licensure, and experience prerequisites, focusing on clinical trial and pharmaceutical research expertise.
The labor categories are tailored for conducting Investigational New Drug (IND) and pharmacokinetic studies, with an emphasis on Phase I clinical trials and bioequivalence/bioavailability research. Key requirements include advanced degrees (MD, DO, Master's, or Ph.D.), fluency in English, strong communication skills, and substantial professional experience ranging from three to five years in clinical research, bioanalytical methods, and study coordination. The document is related to a Food and Drug Administration (FDA) solicitation for Post-Market Bioequivalence Studies, suggesting it is part of a comprehensive research contract opportunity.
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Other files
| File | Type | Posted |
|---|---|---|
| Attachment 1-Price Worksheet.docx | DOCX document | |
| Attachment H - Past Performance Questionnaire.doc | DOC document | |
| Attachment F - Sample Task Order Statement of Work.docx | DOCX document | |
| Attachment E - Labor Categories Minimum Qualifications.docx | DOCX document | |
| Questions.docx | DOCX document |
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Attachment No: G Labor Categories & Minimum Qualifications for Sample Task Order
Labor Categories
| Name |
| Description |
| Principle Investigator (PI) |
| · Assumes responsibility as the PI for all clinical research activities including, but not limited to eligibility evaluation, safety assessment and documentation. |
· Ensures that it is run in accordance with applicable regulations, guidance, and policies to provide assurance that the rights, welfare, and safety of participants are protected and that the trial data are credible and accurate.
· Delegate authorities to qualified and trained personnel.
· Experience with in developing study protocols, protecting subject’s right, safety and welfare, supervising staff, clinical data management, and overseeing the conduct of in vivo human study of oral drug products are preferred.
· Follow requirements depicted in FDA form 1572.
· Reads, writes, and speaks fluent English.
· Excellent verbal and written communication skills.
· Experience with overseeing Phase I type clinical trials.
· Bioequivalence/bioavailability study oversight experience is preferred.
· Education: a M.D. or D.O. degree from an accredited medical school
· Certifications: CCRP (SoCRA) certifications preferred.
· Licensure: Active medical license in appropriate jurisdiction.
· Experience: Minimum five years of serving as a PI of clinical trials including IND studies required.
| Bioanalytical Scientist |
| · Oversees all processes relating to the bioanalysis of small molecules. |
· Develop and validate the bioanalytical methods suitable for detection of various small molecule analytes including, but not limited to parent drugs, metabolites, and isomers in accordance with applicable regulations, guidance, and policies.
· Experience working with LC-MS/MS for development/validation of method and analysis of small molecules required.
· Reads, writes, and speaks fluent English.
· Excellent verbal and written communication skills.
· Education: Master’s Degree or Ph.D. in bioanalytical, chemistry or related field relevant to LC-MS/MS work.
· Certifications: Not required
· Licensure: Not required
· Experience: Minimum three years of development and validation of LC-MS/MS method for pharmaceutical compounds in support of clinical trials required.
| Study Coordinator |
| · Has minimum of five years of experience in coordinating the studies conducted under Investigational New Drugs (INDs) and/or pharmacokinetic (PK) studies. |
· Has good working knowledge of Good Clinical Practices (GCP), Good Documentation Practices (GDP), and applicable regulations, policies, and guidance.
· Performs and coordinates a variety of tasks described in the protocol or related site standard operating procedures (SOPs)/manuals of operations (MOPs).
· Assists in creating the various documents as needed, completes and organizes study documents per GDP and site SOPs.
· Creates and maintains the study-related logs in discussion with FDA.
· Completes and finalizes sponsor-required documents.
· Anticipates and reports the subject and/or study needs in a timely manner.
· Has Phase I and/or PK study experience.
· Experience and knowledge with drug of abuse studies preferred.
· In-depth, up-to-date knowledge of essential documents (Investigator Site File and Trial Master File) preferred.
· Reads, writes, and speaks fluent English
· Excellent verbal and written communication skills
· Education: Bachelor’s Degree in life science, health care or related field.
· Certifications: CCRP (SoCRA) or CCRC (ACRP) certifications preferred.
· Licensure: Not required
· Experience: Minimum five years of coordinating experience of IND or PK studies as a study coordinator required.
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