Clinical Data Assistant

Job Title: Clinical Data Assistant

Department: Study Support

Location: Hybrid, Rochester NY

Hours Per Week: 40

Schedule: Days; Monday – Friday

SUMMARY

The Clinical Data Assistant works with clinical trial sites and client contacts to fully document and resolve 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 items that may delay a report from being sent. Acts as quality control during the requisition accession entry process.

RESPONSIBILITIES

• 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 with answering incoming phone calls and emails, issue on-demand patient reports and manage 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.
• Tracking of reference laboratory results and entry into CTMS according to the agreed time frames. Ensure that appropriate laboratory staffs are informed of received reference laboratory results, so that they can authorize the results in a timely manner. Filing of reference laboratory results.
• CTMS data entry / accessioning data entry.
• Report release from CTMS, depending on experience. Distribution of hard copy reports as required. Re-issue of reports following request from sites or Sponsors.
• All aspects of data (to include action items/CTAs) cleaning including site contact, escalation to ACM Project Manager (PM) according to the appropriate Standard Operating Procedure (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 Food & Drug Administration (FDA), Medical & Healthcare Regulatory Agency (MHRA), New York State Department of Health (NYSDOH), Good Clinical Practice (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 & procedures.
• Participates 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.

PREFERRED QUALIFICATIONS

• Bachelor’s degree in life science preferred
• 1 yr in specimen management, or laboratory preferred
• Ability to multi-task and prioritize workload.
• Critical thinking and ability to problem-solve
• Strong attention to detail

PHYSICAL REQUIREMENTS: 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.

PAY RANGE: $20.00 - $24.00

Salary : $20 - $24