Clinical Trials Associate Project Manager
New
R
Rochester Regional HealthClinical research
Remote, United StatesFull-TimeManager
Salary65,000 - 85,000 USD per year
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Job Details
- Experience
- Minimum of 1 year of experience working in a clinical trials, laboratory or health care setting required
- Required Skills
- Problem Solving
Requirements
- Have at least 1 year of experience working in a clinical trials, laboratory, or health care setting.
- An associate’s degree is strongly preferred.
- Have a general working knowledge of FDA, NYSDOH, GCP, ICH, and other pertinent regulations as they relate to central laboratory functions.
- Demonstrate problem-solving skills.
- Demonstrate communication skills.
- Follow company policies and procedures and maintain patient and client confidentiality.
Responsibilities
- Represent ACM as the client’s primary point of contact and maintain customer service and satisfaction.
- Manage low-complexity studies with varying numbers of protocols.
- Review clinical protocols and assist with protocol setup.
- Develop or support the Global Laboratory Specification Document, Investigator Manual, and protocol-specific Global Work Practice Instructions.
- Support quality audits and inspections of clinical trials.
- Evaluate and communicate monthly project metrics and review trial budgets.
- Oversee study conduct, help meet client goals and timelines, and troubleshoot issues.
- Handle assigned on-call coverage and regulatory study documentation, including collection, maintenance, and archiving.
- Develop protocol-specific procedures as needed and provide project management administrative support.
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