Senior CRA (remote-based)

Hobson Prior are currently in search for a Senior CRA to join a fast-paced biopharmaceutical organisation who are creating ground-breaking products that have never been made before. The role will be on a permanent basis and to be able to work remotely anywhere across the East Coast USA.

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

Key Responsibilities:

• You will confirm monitors have suitable training to perform their role. Including Site qualification visits, Initiation, Interim monitoring and site close-out visits.
• To supervise site activation process for each study.
• You will develop and monitor metrics to assess the monitor and site performance. In the event of performance concerns, evaluate the cause and risk mitigation of a study.
• You will review data to recognise potential issues or inconsistencies that could signal problems with data collection or monitoring.
• Informed Consent Forms, study-specific plans, manuals, Case Report Forms, training materials, CRF completion guideline as well as User Acceptance Test of the EDC system for each study Review workload requirements and provides resources for all clinical field activities.
• Ensure the direct reports perform their duties in line with the code of Federal Regulations of Food and Drug Administration and the ICH guidelines, SOP.
• You will develop a Monitoring Plan for each clinical trial.
• Support in the preparation of clinical study documentation such as study protocols.
• Train monitors and other clinical trial support staff.
• You will track patient enrolment and recommend solutions to monitoring staff to increase appropriate enrolment of qualified subjects.
• You will offer support for the processing of data queries.
• Review and approve monitoring visit reports, confirmation letters and follow-up letters.
• Support in review of protocols.
• Review site-level ICF and site-related material.
• Co-Monitor as required to provide coaching and manage the performance of CRAs.
• May be required to generate study documents such as monitoring report templates, monitoring manual, study operations manual, source data verification plan, laboratory manual, ICF.

Skills:

• Excellent communication, interpersonal and organizational skills.
• Effective problem-solving skills.
• Attention to detail and meet specified timelines.
• Computer literacy, proficiency in Microsoft Office.

Requirements:

• At least 5-8 years' monitoring experience, working as a CRA.
• You can create and sustain effective working relationships with co-workers, managers, investigator site personnel and service providers.
• Excellent knowledge of ICH Guidelines and GCP including a basic knowledge of regulatory requirements.
• Previous experience in early phase immuno-oncology and cell studies.
• Experience in small pharmaceutical/biotech experience preferred.

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.