Home-based CRA (East Coast / Central US) Preferred
Regional CRA Job Description
Primary Job Function
ProClinical is recruiting for the new position of a Regional CRA on a contracted basis. The right applicant will develop, plan, guide and report on the conduct of human clinical research studies. Additionally, they will be required to enter new products into the marketplace or to expand product claims, in compliance with state and federal regulations, industry standards and corporate policies, and will effectively manage multiple clinical sites (up to 12) to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials.
- Comply with applicable Corporate and Divisional policies and procedures, guidelines, standards and regulations.
- Serve as primary contact for investigative site communication for each assigned site.
- Collaborate with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.
- Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
- Train 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.
- Evaluate actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets.
- Assess case report forms (CRFs) for trends in safety, effectiveness, and adherence to protocol.
- Perform 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.
- Prepare, submit and file high quality monitoring visit reports and associated follow-up letters in a timely manner.
- Provide regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance
- Monitor 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 and clinical trial team members.
- Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
- Support study payment activities or accruals, as assigned.
- Ensure all equipment/supplies provided to investigative sites is appropriately reported to Study Manager and/or Lead CRA.
- Interact with internal and external personnel involved in clinical research, including investigators and investigative site personnel.
- Contribute to the successful planning and execution of assigned studies within budget and in conformance with global regulations and internal policies and procedures.
- Accountable for performance and compliance of assigned investigative sites.
- Work with relative autonomy and some supervision.
Skills And Requirements
- BA/BS required.
- Minimum 3 years of independent field monitoring experience for clinical trials
- Ophthalmic and/or medical device monitoring experience.
- Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials.
- Ability to successfully manage multiple 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 in Microsoft Office.
- Proficiency with electronic data capture and electronic Trial Master File preferred.
- Proven ability to operate in a home office environment, with flexibility to travel and report to corporate offices, as appropriate.
- Close proximity to major airport required.
- 80% travel, primarily in Midwest and East (3 weeks per month).
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 Christopher Frank on (+1) 2674056996 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.