Senior Clinical Research Associate (remote-based)

Hobson Prior are currently seeking for a Senior Clinical Research Associate to join a fantastic CRO on a permanent basis where you will be home-based. Our client is focused on supplying clinical research services to global pharmaceutical organisations.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• In this role, you will be working closely with project functional leads as needed.
• You will contribute to site identification and feasibility activities.
• Responsible for preparing accurate and timely visit reports in accordance with the monitoring plan and/or SOPs.
• You will be facilitating site audits and will audit finding resolutions.
• Responsible for providing feedback to management and cross-functional study team on any current or potential risks or problems affecting the conduct of the clinical trial.
• You will be responsible for gathering and assessing essential documents and performing reconciliation of the Investigator Site File.
• You will attend internal and external project calls as requested and per budget to proactively provide required site updates.
• Responsible for all aspects of study site management. (e.g. Training site staff, ensure supply of study material, IMP and trial documents, recruitment updates, etc...).
• Conduct pre-study visits, site initiation visits site monitoring visits and site closeout visits per SOPs/WPDs.
• Assesses IP accountability, dispensation, and compliance at the investigative sites.
• Demonstrates working knowledge of applications and Systems (e.g. CTMS, eTMF, IVRS/IWRS and EDC).
• May supervise work of, or mentor, less experienced CRAs, based on Mentoring program.
• Serve as an observational visit leader.
• Feedback on any areas requiring improvement within the department and involvement in initiatives such as updating SOPs, Work instructions and Processes.
• Can be involved in other tasks as assigned by Management, CTMs and PMs.
• Escalate in timely manner any issue related to Quality or Data integrity.

Key Skills:

• Excellent communication skills.
• Strong presentation skills.
• Strong problem-solving skills / ability to make decisions independently.
• Highly developed mentoring and motivational skills.
• Ability to establish/maintain good relationships with sites/colleagues/clients.

Requirements:

• The ideal candidate for this role will have a Bachelor's degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required.
• Proficiency in written and spoken English; fluent in host country language.
• Previous CRO experience is required.
• You will have previous experience as a Clinical Research Associate with strong demonstration of Clinical Research fundamentals.
• Strong experience in CTMS, eTMF IXRS and EDC systems.
• Excellent knowledge of regional clinical research regulations and ICH-GCP.
• Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge.
• An advanced degree (Masters, MD, PhD) would be desirable.
• Competent in clinical trial planning and metrics management also desirable.

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.