Senior CRA - (remote-based)
- Permanent
- Clinical Development, Drug Development Project Manager
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Hobson Prior are looking for a Senior CRA to join a collaborative culture at a world-wide, full-service Clinical Research Organisation where you will be required to work remotely within the US. If you are interested in this role and feel you'd be a great fit, then please get in touch now!
Please note that to be considered for this role you must have the right to work in this location.
Key Responsibilities:
- Possesses detailed and current knowledge of the study protocol, site monitoring plan, study manuals, Good Clinical Practices and Code of Federal Regulations and local country regulatory requirements.
- Schedules and conducts site visits, including site qualification, initiation, interim, for cause, pharmacy and close out monitoring visits. Prepares and obtains required project approvals and ensures distribution of site visit reports within timelines, and tracks outstanding action items or tasks.
- Collects, reviews, maintains and/or provides required regulatory documents to designated sponsor or project representative. Review includes assessment of completeness, accuracy and compliance with regulatory and local agency requirements.
- Communicates and coordinates effectively with internal project staff members, site staff, sponsors, clients and other external colleagues.
- Coordinates with project team and other study personnel to determine data collection requirements based on the protocol, and may test electronic (or paper) case report forms, or the Monitoring Status Report (MSR) as required.
- Reviews, coordinates, contributes to and processes project documents and required reports, such as study protocol documents and consent forms, SAE, project and protocol deviation reports, accrual and other study status and/or study website reports.
- Reviews and contributes to the development and/or modification of study and project materials, such as Manual of Operating Procedures (MOPs), Monitoring Plans, User Guides and Data Management Handbooks.
- Works with sites during site monitoring visits to resolve protocol monitoring module discrepancies, as well as data discrepancies resulting from queries and Missing Forms & Values Reports.
- Attends and participates in sponsor, project and functional group meetings.
- Schedules and completes training in accordance with project needs and the travel policies.
Requirements:
- Bachelor's degree in a scientific discipline or equivalent experience; combination of training and experience will be taken under consideration.
- Ability to travel domestically and internationally up to 75%.
- Minimum of 4-6 years of clinical research/monitoring experience, specifically in oncology.
- Demonstrated understanding of regulatory obligations for a Clinical Research Associate and relevant ICH guidelines.
- Successful completion of ACRP CCRA or equivalent certification within one year of hire/transfer date.
- Skilled in prioritization, problem-solving, organization, critical thinking, decision-making, time management and planning activities.
- Self-motivated and high attention detail required.
- Ability to collaborate with internal and external colleagues and work well in team-oriented setting.
- Excellent oral and written communication; exceptional interpersonal skills.
- Ability to work remotely with a high degree of independence.
- Skilled in data management/computer proficient in Microsoft Office.
Apply now:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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