PPD-Pharmaceutical Product Development

Senior Clinical Research Associate (CRA)

PPD-Pharmaceutical Product Development

Remote
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to PPD-Pharmaceutical Product Development, a global contract research organization dedicated to helping our clients bring life-changing therapies to patients around the world. We are currently seeking a highly experienced Senior Clinical Research Associate (CRA) to join our dynamic and passionate team. As a Senior CRA at PPD, you will play a crucial role in the development and execution of clinical trials, working closely with cross-functional teams to ensure the highest standards of quality and compliance. This is an exciting opportunity for a driven and detail-oriented individual with a strong background in clinical research. If you are looking to take the next step in your career and make a meaningful impact in the pharmaceutical industry, we encourage you to apply for our Senior CRA position.

  1. Conduct and manage site qualification, initiation, monitoring, and close-out visits for assigned clinical trials according to protocol, study timelines, and applicable regulations.
  2. Collaborate with cross-functional teams, including project managers, study coordinators, and data managers, to ensure successful execution of clinical trials.
  3. Review and verify clinical trial data and ensure accuracy and completeness of data collection.
  4. Communicate effectively with study sites, investigators, and sponsors to build and maintain strong relationships and ensure compliance with study protocols and regulations.
  5. Identify and promptly report any study-related issues or concerns to the project team, and provide solutions and recommendations to resolve them.
  6. Assist in the development and review of study documents, including protocols, informed consent forms, case report forms, and study manuals.
  7. Train and mentor junior CRAs on study procedures, regulations, and company standards.
  8. Conduct site audits to ensure compliance with protocol, SOPs, and regulatory requirements.
  9. Proactively identify and escalate any potential risks or issues that may impact study timelines or quality.
  10. Collaborate with study team members to ensure timely resolution of data queries and discrepancies.
  11. Maintain accurate and up-to-date study documentation, including site visit reports, trackers, and study files.
  12. Ensure compliance with Good Clinical Practice (GCP) guidelines, company standard operating procedures (SOPs), and applicable regulations.
  13. Participate in study meetings and provide updates on study progress, issues, and resolutions.
  14. Contribute to continuous improvement initiatives within the clinical operations department.
  15. Keep updated on industry trends and developments, and apply this knowledge to improve study processes and procedures.
Where is this job?
This job opening is listed as 100% remote
Job Qualifications
  • Bachelor's Or Master's Degree In A Relevant Field (Such As Life Sciences, Pharmacy, Or Nursing).

  • Minimum Of 5 Years Of Experience As A Clinical Research Associate, Preferably In A Leadership Or Senior Role.

  • Thorough Knowledge Of Fda Regulations, Ich-Gcp Guidelines, And Other Relevant Industry Standards.

  • Strong Communication And Interpersonal Skills, With The Ability To Effectively Lead And Mentor A Team.

  • Proven Track Record Of Successful Project Management And Execution Of Clinical Trials, Including Experience With Various Phases And Therapeutic Areas.

Required Skills
  • Vendor Management

  • Data Management

  • Quality Control

  • Risk assessment

  • Medical Writing

  • Regulatory Submissions

  • Study Coordination

  • Site Monitoring

  • Protocol Compliance

  • Investigator Training

  • Gcp Knowledge

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Networking

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Senior Clinical Research Associate (CRA) is between $85,000 to $125,000 per year. This can vary depending on factors such as location, experience, and the specific company or organization. Entry-level CRAs may make around $60,000 to $80,000 per year, while more experienced CRAs with advanced degrees and certifications can potentially earn upwards of $150,000 or more. It is important to note that these

Additional Information
PPD-Pharmaceutical Product Development is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedJuly 22nd, 2024
Apply BeforeMay 22nd, 2025
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About PPD-Pharmaceutical Product Development

PPD, Inc. is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

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