Research Associate, Clinical Research

Overview

Job Title:

Research Associate
Department:
Study Support

Location:

Hybrid | Onsite Location Rochester, NY
Hours Per Week: 40 hours

Schedule:

Monday – Friday

As a member of the Clinic Trials Study Management (CTSM) team, the Research Associate works with clinical trial site and client contacts to fully document and resolve data reconciliation queries pertaining to patient visit results. Ensures patient reports are provided to study contacts in a timely manner by monitoring ACM’s internal Clinical Trials Management System and addressing any data queries that may delay a report from being issued.

• Guarantee client satisfaction by providing exceptional service through a consistent customer‑centric approach, focus on precision delivery and flexibility to meet customer expectations.
• Maintain positive working relationships with CT clients, Business Development Directors, Clinical Trials Study Management and key stakeholders.
• Oversee site support by performing set‑up duties for investigator sites at the start of a clinical trial. As a backup, support site day‑to‑day activities by answering incoming phone calls and emails, issuing on‑demand patient reports and managing alert notifications as required by the study.
• Maintain regulatory requirement by managing documents associated with project set‑up and validation activities.
• Support the Clinical Trials Study Management team in print compiling and archiving.
• Track reference laboratory results and entry into CTMS according to agreed time frames. Ensure that appropriate laboratory staff are informed of received reference laboratory results so that they can authorize the results in a timely manner. File reference laboratory results.
• CTMS data entry / accessioning data entry.
• Report release from CTMS, depending on experience. Distribute hard copy reports as required. Re‑issue reports following request from sites or Sponsors.
• All aspects of data cleaning (including action items/CTAs), site contact, escalation to ACM Project Manager (PM) according to SOP, resolution and sample release from the CTMS system, and filing of associated documentation.
• Facilitate logistics for incoming and outbound materials and mail for CT.
• Maintain a general working knowledge of FDA, MHRA, NYSDOH, GCP, ICH and other pertinent regulations.
• Assist in process improvement within the Clinical Trials Project Management team by developing methods to improve productivity, service, quality, cost savings, policies and procedures.
• Participate in Clinical Trial meetings and task forces to develop standardization in the set‑up process across protocols and departments.
• Participate in training to maintain relevant working knowledge of Clinical Trials.
• Perform other duties as assigned.

• BS Degree preferred.
• 1 year working in clinical trials or health care setting.
• Strong interpersonal and communication skills.
• Strong time management and organizational skills.
• Ability to work independently and in a team setting.
• Proficient in Microsoft Office.

S
- Sedentary Work
- Exerting up to 10 pounds of force occasionally. Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

$21.00 - $24.00 per hour.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.