Senior Clinical Research Associate
Iovance Biotherapeutics, Inc.
Google Cloud Platform
Clinical Research Associate
Praxis
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $103,000 - $122,000 per year
Job Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, ICH-GCP, and regulatory requirements.
- Verify source data and ensure accuracy, completeness, and consistency with case report forms (CRFs) and study databases.
- Review monitoring reports and follow-up letters to ensure timely resolution of issues.
- Assist CTMs in site activation activities and provide ongoing site management support.
- Collaborate with cross-functional teams (Data Management, Medical, Regulatory, Quality) to maintain high-quality trial conduct.
- Identify and escalate protocol deviations, data integrity issues, and safety concerns.
- Maintain study files and documentation, ensuring compliance with SOPs and trial master file (TMF) requirements.
- Support investigators and site staff with training and guidance on study procedures.
- Perform direct site management, monitoring visits, and close collaboration with site staff and cross-functional teams to support the successful execution of studies.
Requirements
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus).
- 3+ years of clinical research experience, including site monitoring responsibilities.
- Strong knowledge of ICH-GCP, FDA regulations, and international trial standards.
- Excellent organizational, communication, and problem-solving skills.
- Ability to manage multiple priorities and work independently as well as in a team.
- Willingness to travel as needed for monitoring visits (up to 50–75%).
- Previous experience in CNS or rare disease clinical trials (preferred).
- Familiarity with registrational trial requirements (preferred).
- Comfort with screen work, basic hand coordination, and focus; reasonable accommodations may be made.
Benefits
- At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
- Dollar-for-dollar 401(k) match up to 6% on eligible contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Extremely flexible wellness benefit.
- Generous PTO, paid holidays and company-wide shutdowns.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
site qualificationsite monitoringdata verificationprotocol adherencestudy documentationtrial master file (TMF) managementclinical researchICH-GCPFDA regulationsCNS clinical trials
Soft skills
organizational skillscommunication skillsproblem-solving skillsteam collaborationindependent workmulti-priority managementtraining and guidance
