[Hiring] Clinical Trials Associate Project Manager @Rochester Regional Health

Role Description

The primary role of the Clinical Trials (CT) Associate Project Manager is to liaise with ACM Global Central Laboratory clients, representing the laboratory aspects of conducting the clinical trial. The CT Associate Project Manager is responsible for all aspects of their assigned clinical trials, from the set up stage, throughout the maintenance period and to study close out, facilitating and coordinating the required functions.

Responsibilities

• Represent ACM as the client's primary point of contact, maintaining a high level of customer service and satisfaction.
• Manage low complexity studies per the ACM study assessment tool with a varying number of protocols.
• Review clinical protocols and assist with protocol set-up functions as required.
• Develop and/or support the Global Laboratory Specification Document, Investigator Manual, and protocol specific Global Work Practice Instructions.
• Participate in and support Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agencies.
• Evaluate and communicate monthly project metrics and analyze all activity related to the trial, including monthly budget review.
• Assume full responsibility for study conduct on behalf of ACM, ensuring client’s goals and timelines are met.
• Perform troubleshooting and problem solving functions as the need arises.
• Responsible for On-Call coverage duties as assigned.
• Assume responsibility for regulatory required study documentation and comply with standard procedures for collecting, maintaining, and archiving materials.
• Develop protocol specific procedures as needed.
• Perform duties with a general working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations.
• Understand and follow company policies and procedures while maintaining patient and client confidentiality.
• Provide support for Project Management administrative functions as needed.
• Perform other duties as assigned.

Qualifications

• Minimum of 1 year of experience working in a clinical trials, laboratory or health care setting required.

Preferred Qualifications

• Associate’s degree strongly preferred.
• Experience working in a clinical trial, laboratory or healthcare setting.
• Excellent problem solving and communication skills.

Physical Requirements

• Sedentary - primarily office-based and require prolonged sitting (67–100% of the workday).
• Minimal physical effort and lifting limited to under 10 lbs.
• Fine motor skills necessary for computer work, writing, and telephone use.
• High cognitive and emotional demands due to extended concentration, frequent interruptions, and independent decision-making.
• Low physical exposure, but may involve contact with infectious agents in healthcare environments.
• Some roles may require flexible hours, TB screening, or a valid driver’s license.

Pay Range

$65,000.00 - $85,000.00

Company Description

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any characteristic protected by federal, state, or local law.