Senior Clinical Research Associate

Parexel

22h•Remote

About The Position

At Parexel, the Senior Clinical Research Associate (Sr CRA) is responsible for supporting monitoring and site management activities for client-sponsored studies. These activities are conducted in accordance with ICH GCP, applicable country/local regulations, and client SOPs. Interactions with sites occur both on-site and off-site, with all interactions documented in CTMS. The role requires collaboration with cross-functional clinical study teams and investigator site personnel to ensure efficient and effective study deliverables. The Sr CRA also oversees activities performed at investigator sites where monitoring may be supported by a CRO partner, through the review of operational data and metrics. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. They leverage deep local knowledge and a global breadth of clinical, regulatory, and therapeutic expertise, working in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind. Their proven track record spans over 40 years, advancing clinical research in complex areas and harnessing innovation to drive efficiencies across all phases of the clinical development process.

Requirements

Bachelor's degree (or equivalent)
Minimum of 5 years of related experience for Snr 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 (e.g., FDA, EMA, PMDA).
Effective communication and interpersonal skills to build relationships internally and externally.
Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories.
Demonstrated ability to deliver clear and concise written reports.
Effective prioritisation 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, both on-site and remotely.
Partner with Clinical Trial Liaison (CTL) and other client functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) to support site activation and deliverables.
Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct.
Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements.
Prepare and maintain Oversight Monitoring Plan.
Perform review of study metrics, assess CRO Clinical Research Associate (CRA) and Investigator Site performance and identify sites for oversight monitoring visits.
Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA.
Review site source documentation and verify accurate data capture (ALCOA principles).
Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/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 completeness of site documentation (e.g., investigator site file/regulatory binder contents).
Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary.
Track, trend, and report issues, escalating them to the appropriate teams when required.
Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.
Actively participate in team meetings and process improvement initiatives to enhance study outcomes.