In-house CRA Monitor
Our client, a pharmaceutical sponsor company focused on ophthalmologic device research, is seeking CRA Monitors to directly join their team! Please email Mike Rooney at firstname.lastname@example.org for more information.
As a key member of the clinical affairs team, this individual will develop and
maintain professional working relationships with clinical investigative sites, and study Site Management Start‐up activities, while serving as the primary contact for site personnel.
This person will conduct Site Initiation Visits that include protocol specific training, Interim
Monitor Visits, Close‐Out Visits, and the reconciliation of study documents for discussion with the Principal Investigator and Site personnel. Key initiatives will include developing and revising clinical SOPs, monitoring tools, source documents, and other study related documents.
Our client is increasing the number of Monitors they are hiring to reduce amount of travel required - 30% all domestic
Reviewing clinical data for accuracy (e.g. tables, listings, figures, clinical study reports)
Reporting significant deviations, discrepancies with study data, and other significant issues noted during monitoring visits in the monitor reports, escalating issues to the
appropriate personnel as needed
Monitoring clinical and/or laboratory data to verify its authenticity to ensure accuracy,
thoroughness, and regulatory compliance, while verifying documentation and timely
reporting of Adverse Events and Serious Adverse Events
Providing technical assistance to study sites regarding the conduct of clinical research
Tracking data forms, reports, and documents necessary for completion of clinical study,
both in‐house and from participating study sites
Performing drug and device accountability, reconciliation, and return of drug/device
Conducting informed consent review, compliance, and verification
Qualified candidates will have:
2+years independent monitoring experience
ophthalmology/complex therapeutic experience
Minimum Bachelor's degree