Senior Clinical Research Associate

Senior CRA -$130,000-150,000 - mid-sized CRO

Our CRO Partner

Our client is a well-established global Contract Research Organisation (CRO) that partners with biotechnology, pharmaceutical, and medical device companies to support the successful development of innovative therapies from early-phase research through to commercialisation. With operations spanning North America, Europe, and Asia, they have built a reputation for delivering high-quality clinical development services, regulatory expertise, and tailored solutions that help sponsors navigate increasingly complex development programmes.

The organisation offers expertise across a broad range of therapeutic areas, with particular strength in oncology, neurology and psychiatry, immunology, vaccines, endocrinology and metabolic disorders. They also have significant experience supporting rare disease, paediatric, and biosimilar development programmes, making them a trusted partner for sponsors developing therapies in both common and highly specialised indications.

Combining global reach with a collaborative, customer-focused approach, they provide employees with the opportunity to work on cutting-edge clinical research programmes that have a meaningful impact on patient outcomes worldwide.

The Role

The Senior CRA is responsible for the selection, initiation, monitoring, and close-out of investigative sites. Major responsibilities include ensuring the safety and well-being of study participants at assigned site(s); ensuring site compliance with Good Clinical Practice (GCPs), applicable regulations, the protocol and study plans; ensuring data integrity through source data verification and monitoring process; and ensuring site compliance with all Investigational Product (IP) storage, inventory, dispensing, dosing, and disposition requirements.

A Senior CRA provides mentoring to other CRAs and study support staff and contributes to department training and process improvement initiatives. A Senior CRA performs duties with minimal direction and oversight. A Senior CRA may be assigned to supervise the work performed by other CRAs and act as a backup to the study Clinical Trial Manager.

All CRAs report to the Senior Director of Monitoring in the US.

To be considered for the Senior CRA position you must have at least 4 years of independent on-site clinical monitoring experience. This role is exclusively open to candidates in states on PST, MST & CST time zones - excluding California.

Key Responsibilities

• Participates in the identification of potential investigative sites, conducts site qualification visits, collects, and reviews site regulatory documents, and prepares site qualification visit reports and associated documentation; participates in the final selection of investigative sites.
• Conducts site initiation visits; trains site personnel on Client and regulatory requirements for study conduct; participates in and/or conducts site meetings and investigator meetings, and prepares site initiation visit reports and associated documentation.
• Conducts site monitoring visits and follow-up to identify significant problems and issues, and to ensure that all clinical aspects of studies are being carried out in accordance with study plans, GCPs, and applicable regulations; prepares monitoring visit reports and associated documentation.
• Reviews on-site files and records, Case Report Forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies; initiates corrective action as required.
• Assists in submissions to the Independent Ethics Committees (central and local) and to Competent / Regulatory Authorities.
• Arranges site payments and facilitates site budgets and contracts as requested.
• Ensures training is performed within a reasonable period and is current and appropriately documented.
• Ensures protocol deviations are appropriately documented, and action items are followed through to completion.
• Manages site monitoring visit schedule, and the follow-up of issues between visits, along with ongoing regular communication with the sites and the clinical study team.
• Maintains close contact with the site staff, to be aware of patient enrolment, enrolled issues Ensures essential documents are filed in the Trial Master File (TMF) according to the project guidelines.
• Ensures appropriate and timely transmission of clinical data to data management; reviews data queries, and clarifies and/or obtains changes to data as appropriate.
• Conducts site close-out visits to include final IP reconciliation and disposition, review of completeness and accuracy of files, and retrieval of documents for the TMF; prepares site close-out visit reports and associated documentation.
• Senior CRA assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in development of participant tracking systems; conducts monitoring assessment visits for the purpose of rescuing a troubled site or performing audit preparation at the direction of the CTM
• Senior CRA oversees work for assigned CRAs on a designated project; reviews and approves monitoring visit reports; manages the visit schedule; provides feedback during the annual review process regarding performance of assigned CRAs

If this role sounds interesting to you then please hit apply and RBW Consulting will be in touch to discuss your application further.