Senior Clinical Research Associate
5 days ago
Piper Companies is seeking a skilled Clinical Research Associate to join their team and contribute to the success of their clinical research organization.
Key Responsibilities:
- Develop and maintain strong relationships with investigative sites and client personnel to ensure seamless trial execution.
- Monitor sites for accuracy and validity of patient records and clinical notes, ensuring compliance with regulatory requirements.
- Provide regular trial status and progress reports to the trial manager and client, ensuring transparency and open communication.
- Manage and maintain data and documents required by local and ICH regulatory authorities, ensuring compliance and accuracy.
- Ensure that Standard Operating Procedures (SOPs) are followed and assist with client audits and regulatory inspections, maintaining a high level of quality and integrity.
Requirements:
- 5+ years of clinical monitoring experience, with a preference for experience in a Contract Research Organization (CRO) environment.
- Strong knowledge of FDA, ICH GCP, and local regulations, with prior experience in therapeutic areas such as Oncology, CNS, Infectious Disease, or Vaccines.
- Excellent communication, interpersonal, and organizational skills, with a strong ability to work independently and as part of a team.
- Bachelor's degree or equivalent experience, with a strong foundation in clinical research and a passion for delivering high-quality results.
Compensation and Benefits:
- Salary Range: $130,000-$150,000 based on experience, with a competitive comprehensive benefits package included.
Keywords:
- Clinical Research Associate, CRA, Registered Nurse, RN, Neuro, Infectious Disease, Vaccines, Rare Disease, Site Management, FDA, Regulatory, Regulatory Affairs, Clinical Operations, Clinical Research, Clinical Trials, CRO, Clinical Research Organization, Clinical Team, ICH, GCP, Contract, Biopharmaceutical, Biopharma, Pharmaceutical, Pharma, Medical Device, Therapeutics, Monitoring, Clinical, Management, Biological, Scientific, Patient Recruitment, Health, Dental, Vision, Retirement, Benefits, Remote, Northeast
#LI-PB2 #LI-REMOTE
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