Attachment G - Labor Categories Minimum Qualifications Sample Task Order.docx
DOCX document 26 KB Posted
- Solicitation number
- 75F40124R00023
About this file
This document provides labor categories and minimum qualifications for a sample task order. It defines four key labor categories: Principal Investigator, Bioanalytical Scientist, Study Coordinator, and Data Manager. Requirements are outlined for each role, including descriptions of responsibilities, education and certification requirements, and minimum years of relevant experience. The Principal Investigator would assume responsibility for all clinical research activities and ensure compliance with regulations. The Bioanalytical Scientist would oversee bioanalysis of small molecules using LC-MS/MS methods. The Study Coordinator would coordinate studies conducted under Investigational New Drugs and perform a variety of protocol-specified tasks. The related federal contract opportunity is for post-market bioequivalence studies of generic drug products through the Department of Health and Human Services Food and Drug Administration.
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Other files
| File | Type | Posted |
|---|---|---|
| QA response.xlsx | XLSX spreadsheet | |
| 75F40124R00023.pdf | ||
| Attachment F - Sample Task Order Statement of Work.docx | DOCX document | |
| Attachment B - FAR 52.212-5-Contract-Terms-and-Conditions (SEP 2023) (Updated).docx | DOCX document | |
| RFP.pdf | ||
| Attachment A - Pricing for Sample Task Order.xlsx | XLSX spreadsheet | |
| Attachment H - Past Performance Questionnaire.doc | DOC document | |
| Attachment E - Labor Categories Minimum Qualifications.docx | DOCX document | |
| Attachment D - HHS Class Deviation 2020-02 - Accelerated Payments.pdf | ||
| Attachment C - FAR Deviation 18-01 (Whistleblower Protection-Commercial).pdf |
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Text version
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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