Clinical Research Associate
Proclinical is currently recruiting for a REMOTE Clinical Research Associate with a pharmaceutical company.
- 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.
- Collaborating with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.
- 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.
Skills and Requirements:
- 5+ years of independent field monitoring experience for clinical trials.
- Risk Based and Remote Monitoring experience required.
- Ophthalmic medical device industry experience required (e.g. intraocular lens (IOL) - Must have refractive surgical trial monitoring experience
If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.
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.