Senior Clinical Research Associate – Field Based
Location
Florida
Posted
8 days ago
Salary
$108.5K - $201.5K / year
Seniority
Senior
Job Description
Senior Clinical Research Associate – Field Based
Kerr Dental
• Manage trusted site relationships and perform on-site and remote monitoring activities to support the initiation, conduct, and timely completion of Phase I – IV trials • Build strong relationships to ensure site performance, quality, and milestone achievement • Manage Phase I to Phase IV trials per monitoring plans and company procedures • Conduct site initiation visits and deliver ongoing training for site personnel • Identify risks, resolve issues, and escalate concerns as needed • Collaborate with cross-functional teams to drive efficient study execution • Support timely data query resolution and ensure data accuracy
Job Requirements
- Minimum of three years of clinical site monitoring experience
- Minimum of Bachelor’s degree in science, healthcare, or a related field
- Strong understanding of clinical research and drug development processes
- Knowledge of ICH/GCP and 21 CFR regulatory requirements
- Ability to manage multiple priorities and work independently
- Strong site management, communication, and problem-solving skills
- Fluency in English, written and spoken, Spanish highly desired
- Ability to drive and travel extensively, up to 80%, in a company vehicle
Benefits
- Health insurance
- Life and disability benefits
- 401(k) with company contribution and match
- Generous time off package including vacation, personal days, holidays, and other leaves
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• Performs and coordinates all aspects of the clinical monitoring and site management process • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation • Manages procedures and guidelines from different sponsors and/or supervising environments • Ensures that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs • Develops collaborative relationships with investigational sites • Ensures data accuracy through SDR, SDV and CRF review • Documents observations in reports and letters in a timely manner • Escalates observed deficiencies and issues to clinical management expeditiously • Ensures study systems are updated per agreed study conventions • Participates in investigator meetings • Initiates clinical trial sites according to relevant procedures • Ensures trial close out and retrieval of trial materials • Contributes to the project team by assisting in preparation of project publications/tools
Senior Clinical Research Associate – Field Based
NovartisNovartis is a leading global pharmaceutical and healthcare research and solutions company dedicated to improving patient lives by uncovering solutions to curren
• Lead assigned sites as the primary point of contact throughout study delivery • Build strong relationships to ensure site performance, quality, and milestone achievement • Manage Phase I to Phase IV trials per monitoring plans and company procedures • Conduct site initiation visits and deliver ongoing training for site personnel • Perform remote and on-site monitoring to ensure compliance and patient safety • Maintain accurate documentation and update all clinical systems in a timely manner • Identify risks, resolve issues, and escalate concerns as needed • Collaborate with cross-functional teams to drive efficient study execution • Support timely data query resolution and ensure data accuracy • Act as a subject matter expert across study activities when required
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Business Analyst
Navtech, Inc.NAVTECH INC 1600 Golf Road. Suite 1200, Rolling Meadows, IL 60008 Ph: (224) 348-1340 Email: alex@navtechusa.com Website: www.navtechusa.com E-Verified Company
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