Senior Clinical Research Associate - Early Development - Central/NE Region - FSP

Parexel•United States-Ohio-Remote, OH

12d

About The Position

The Senior Clinical Research Associate (SrCRA) supports monitoring and site management activities for client-sponsored studies. Activities are conducted in accordance with ICH GCP, applicable country and local regulations, and client SOPs. Site interactions take place both on-site and off-site, with documented interactions recorded in CTMS. The role collaborates with cross-functional clinical study teams and investigator site personnel to ensure study deliverables are met efficiently and effectively. It also oversees investigator-site activities that may be supported by a CRO partner, through review of operational data and metrics.

Requirements

Bachelor's degree or equivalent.
At least 5 years of related experience for a Senior CRA.
Strong analytical problem-solving skills and critical thinking abilities.
Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements, such as FDA, EMA, and PMDA requirements.
Effective communication and interpersonal skills to build internal and external relationships.
Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories.
Ability to deliver clear and concise written reports.
Effective prioritization and time-management skills.

Responsibilities

Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs.
Conduct site qualification, initiation, interim, and close-out visits on-site and remotely.
Partner with the Clinical Trial Liaison and other client functions, including Study Start-Up, Global Partnerships, and Trial Optimization, to support site activation and deliverables.
Establish and maintain productive professional relationships with investigator site staff, communicating effectively and solving problems throughout study conduct.
Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance with storage and shipment requirements.
Prepare and maintain the Oversight Monitoring Plan.
Review study metrics, assess CRO CRA and investigator site performance, and identify sites for oversight monitoring visits.
Conduct oversight monitoring visits at sites, independently or alongside a CRO CRA.
Review site source documentation and verify accurate data capture in accordance with ALCOA principles.
Review and report on the status of study conduct at investigator sites and follow up on identified issues and action items.
Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting.
Write and submit accurate monitoring visit reports, oversight monitoring visit reports, and study correspondence in a timely manner.
Periodically verify the completeness of site documentation, such as investigator site files and regulatory binders.
Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as needed.
Track, trend, and report issues, escalating them to appropriate teams when required.
Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.
Participate in team meetings and process improvement initiatives to enhance study outcomes.
Support inspection readiness activities and ensure sites maintain data integrity and protocol deliverables.