Attachment No. 2 - Labor Categories Minimum Qualifications.docx
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Attachment No: 2_Revised as of Amendment #2 Labor Categories & Minimum Qualification
Labor Categories
| Name |
| Description |
| Manager |
| · Leads and performs project area work including drafting the site monitoring plan for each TO. |
· Works as a liaison between FDA and monitor to coordinate all required activities.
· Proposes and implements creative methods to track and complete work effectively and efficiently.
· Meets or communicates with client monthly or as needed, if not daily, to ensure work meets/exceeds client objectives.
· Has two or more years of clinical operations experience in project plans and timeline management, quality standards and risk mitigation;
· Reads, writes, and speaks fluent English; excellent verbal and written communication skills.
· Experience managing Phase I clinical trials, preferably at a sponsor or CRO is preferred, but not required
· Education: Bachelor’s Degree in related field.
· Certifications: CCRP (SoCRA) or CCRA (ACRP) certifications preferred.
· Licensure: Not required
· Experience: Minimum five years of managing experience of monitors/CRAs and/or sites required.
| Principal Investigator (if needed; can be combined with Manager tasks) |
| · Supervises all task orders by effectively managing, providing direction and guidance to the team, and submitting he required reports. |
· Has significant experience conducting clinical research and managing the IND studies.
· Education: Bachelor’s Degree in related field.
· Certifications: CCRP (SoCRA) or CCRA (ACRP) certifications preferred.
· Licensure: Not required
· Experience: Minimum ten years of managing experience of IND studies required.
| CRA/monitor |
| · Has more than five years of experience in on-site monitoring and/or auditing the studies conducted under Investigational New Drugs (INDs) |
· Has Phase I and/or pharmacokinetic study experience and knowledge with drug of abuse studies required.
· Has in-depth, up-to-date knowledge of essential documents (Investigator Site File and Trial Master File)
· Is willing to travel domestically and/or internationally
· Reads, writes, and speaks fluent English; excellent verbal and written communication skills
· Another language skill (Spanish, German, etc) is a plus
· Education: Bachelor’s Degree in related field.
· Certifications: CCRP (SoCRA) or CCRA (ACRP) certifications preferred.
· Licensure: Not required
| Administrative Coordinator (if needed) |
| · Performs administrative activities including scheduling monthly meetings and other tasks to support all task orders as needed. |
· Has knowledge and skills of commonly used concepts, practices, and procedures as an administrative coordinator.
· Relies on instructions and pre-established SOPs to perform the functions of the job.
· Education: high school diploma.
· Certifications: Not required
· Licensure: Not required
· Experience: Minimum twelve months experience.
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