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Clinical Research Associate/Senior Clinical Research Associate- FSP

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Parexel

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Location:
United States

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas.

Job Responsibility:

  • Contributes to the selection of potential investigators
  • As required, accountable for study start-up and regulatory maintenance
  • Trains, supports, and advises Investigators and site staff in study related matters
  • Confirms that site staff have completed and documented the required training appropriately
  • Actively participates in Local Study Team (LST) meetings
  • Contributes to National Investigators meetings
  • Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
  • Drives performance at the sites
  • Updates CTMS and other systems with data from study sites
  • Manages study supplies, drug supplies and drug accountability at study site
  • Performs monitoring visits (remote and onsite), as well as remote data checks
  • Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV)
  • Performs regular Site Quality Risk Assessments
  • Ensures data query resolution in a timely manner
  • Ensures accurate and timely reporting of Serious Adverse Events and their follow ups
  • Prepares and finalizes monitoring visit reports
  • Follows up on outstanding actions with study sites
  • Follows quality issue processes
  • Assists site in maintaining inspection ready ISF
  • Prepares for and collaborates with the activities associated with audits and regulatory inspections
  • Ensures timely collection/uploading of essential documents into the eTMF
  • Ensures that all study documents under their responsibility are available and ready for final archiving
  • Provides feedback on any research related information
  • Collaborates with local Medical Science Liaisons (MSLs) as directed
  • Ensures compliance with the Client’s Code of Ethics and company policies
  • Ensures compliance with local, national, and regional legislation
  • Completes timesheets accurately as required
  • Submits expense reports as required
  • Updates CV as required
  • Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements

Requirements:

  • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
  • Good knowledge of relevant local regulations
  • Good medical knowledge and ability to learn relevant Client Therapeutic Areas
  • Basic understanding of the drug development process
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management
  • Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
  • Excellent attention to detail
  • Good written and verbal communication skills
  • Good collaboration and interpersonal skills
  • Good negotiation skills
  • Proficient in written and spoken English language required
  • Fluency in local language(s) required
  • Ability to travel nationally/internationally as Required
  • Valid driving license per country requirements, as applicable
  • Oncology Experience required
  • Cell therapy experience is strongly preferred

Nice to have:

  • Ability to work in an environment of remote collaborators
  • Manages change with a positive approach for self, team, and the business
  • Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials
  • Good analytical and problem-solving skills
  • Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
  • Ability to understand the impact of technology on projects and to use and develop computer skills
  • Team oriented and flexible
  • Familiar with risk-based monitoring approach including remote monitoring
  • Good cultural awareness
What we offer:
  • Flexible work arrangements
  • Career growth and development
  • Supportive and inclusive environment
  • Diverse therapeutic areas and project exposure
  • Advanced Technology

Additional Information:

Job Posted:
January 24, 2026

Work Type:
Remote work
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