Proclinical is currently recruiting for a Regional CRA for our client located remotely. Successful candidate will collaborate with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.
- Compliance with applicable Corporate and Divisional policies and procedures, guidelines, standards and regulations.
- Serving as primary contact for investigative site communication for each assigned site.
- Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
- Training investigative site personnel to ensure compliance with study requirements and GCP, including, but not limited to the protocol, IRB/EC instructions, industry guidelines, international standards and local and national regulations.
- Evaluating actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets.
- Assessing case report forms (CRFs) for trends in safety, effectiveness, and adherence to protocol.
- Performing on-site monitoring activities for assigned investigative sites in compliance with the approved monitoring plan and SOPs, with specific tasks to include:
- Ensuring that final CRFs are accurate and complete by verifying against source documentation, as assigned.
- Ensuring that all clinical trial documentation is properly reviewed, approved and filed within the Trial Master File and is accessible to investigative site personnel.
- Ensuring investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
- Preparing, submitting and filing of quality monitoring visit reports and associated follow-up letters in a timely manner.
- Providing regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance
- Monitoring overall progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, Study Managers, Lead CRAs, CRAs and other clinical trial team members.
- Maintaining audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
- Supporting study payment activities or accruals, as assigned.
- Ensuring all equipment/supplies provided to investigative sites is appropriately reported to Study Manager and/or Lead CRA.
- Interacts with internal and external personnel involved in clinical research, including investigators and investigative site personnel.
- Accountable for performance and compliance of assigned investigative sites.
Skills and Responsibilities:
- BA/BS or equivalent years of experience required.
- 3+ years of clinical research experience with independent field monitoring experience.
- Medical Device industry experience required.
- Knowledge of ophthalmology required.
- Knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials.
- Ability to successfully manage competing priorities and adapt quickly to changing priorities.
- Ability to problem-solve.
- Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external meetings desired.
- Proficiency with MS Word, Excel and Powerpoint.
- Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate.
- Ability to travel up to approximately 50-75%.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Samantha Reader at (+1) 267-983-0134 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.