Remote - Senior Clinical Research Associate - Level 3

A highly reputable medical device corporation is currently hiring a qualified Remote - Senior Clinical Research Associate - Level 3 to work remotely in the United States.

Description:

• Support execution of clinical studies to support product development and validation while building strong relationships with clinical trial sites.
• Tasks include
• Monitoring including data review for sense/completeness, SDV as required
• Using electronic data systems such as EDC, CTMS, monitoring listings, eTMF, eReg, etc
• Ensure site provides accurate, complete, timely data
• Ensure site supplies remain adequate for study
• Confirm correct data file naming for download files from study instrumentation
• Monitoring visit reports
• Data cleaning, DB lock and COV support,
• Database UAT testing & documentation
• Meet all monitoring metrics
• May be involved in site management at any phase from initial study invitation to COV
• Communicating, tracking & delivering milestones
• Providing regular formal updates to Clinical Trial Lead, Clinical Program Manager, and to line manager
• This role will be responsible for monitoring clinical study sites per SOPs, in conjunction with the site lead CRA and other in-house CRAs.
• Must be knowledgeable and experienced in good clinical practices regulations and maintains a high level of professionalism.
• Must be familiar with remote monitoring, EDC, and electronic study files (ISF, TMF); familiarity with Medrio, SimpleTrials, and Veeva eReg/eSolutions a plus.
• Will participate in project team meetings at site and study levels.
• Will require travel and in person visits to sites.
• Requires outstanding communication and relationship building skills.

Essential Duties & Responsibilities:

• Conducts ongoing remote or on-site monitoring, performs regulatory document reviews, 100% source data verification, assesses protocol adherence of assigned clinical sites.
• Predominantly remote monitoring: SDV, reg doc review, etc. On-site monitoring, dependent on site’s capability and study need
• Monitoring activities/shifts may be required outside standard shift hours.
• Generates a weekly monitoring report which may include gathering input from other team members involved in monitoring and supporting the clinical study site
• Contributes to weekly site progress report
• Ensures collection of all regulatory documents, submits to TMF per sponsor’s procedures, and confirms proper entry into TMF
• Reviews site ISF and ensures completeness and consistency w sponsor TMF
• Works independently to manage assigned clinical tasks and deliverables to meet clinical timelines.
• Collaborates effectively with peers and leadership across departments and across clinical study sites.

Experience and Education Requirements:

• Bachelor's Degree required
• Candidates will have extensive prior experience in similar role with proven track records of successful clinical study completion with adherence to timelines, GCP, and milestones
• 5 plus years minimum previous experience with medical device trials

Preferred Qualifications:

• Professional certification (e.g. CCRA, CCRP, PMP, ACRP, SoCRA, RAPS)
• Experienced with clinical trials in the therapeutic area of Diabetes
• Clinical Trial Management System (CTMS) experience
• Minimum 2 plus years of on-site monitoring experience
• Manage multiple, diversified tasks concurrently and to prioritize projects and tasks effectively.
• Current GCP (Good Clinical Practice) Training

Travel Required:

• Minimal to no travel expected

Scope:

• Demonstrates technical proficiency.
• Works on moderately complex problems where analysis of situations or data requires evaluation.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Interprets data and draws conclusions regarding results used in presented material.

Judgement:

• Exercises judgment within defined procedures and practices to determine appropriate action.
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.