Clinical Research Associate

3 weeks ago

Clarksville, Tennessee, United States Medix™ Full time
Job Overview:

The position of Clinical Research Coordinator at Medix`` is a key role in managing and overseeing clinical trials and research studies. This involves collaborating with healthcare professionals, regulatory bodies, and study sponsors to ensure the integrity and compliance of research.

Key Responsibilities:

  • Study Management: Plan, initiate, and monitor clinical trials from start to finish, ensuring timely completion and data quality.
  • Site Selection and Training: Identify and recruit study sites, providing comprehensive training and support to site staff to ensure seamless execution.
  • Regulatory Compliance: Ensure adherence to Good Clinical Practice (GCP), regulatory requirements, and study protocols, maintaining accurate documentation and records.
  • Data Collection and Analysis: Oversee data collection processes, ensuring data integrity and accuracy, and analyze data to inform study decisions.
  • Patient Interaction: Engage with study participants, including informed consent processes and follow-ups, maintaining a high level of patient satisfaction and safety.
  • Documentation: Maintain thorough and accurate study documentation, including trial master files and regulatory submissions, ensuring easy access and retrieval.
  • Collaboration: Work closely with cross-functional teams, including Principal Investigators, medical writers, and regulatory affairs, to ensure effective communication and study success.
  • Reporting: Prepare and present study progress reports and findings to stakeholders, highlighting key results and recommendations.

Qualifications:

  • Education: Bachelor's degree in life sciences, nursing, or related field (advanced degrees preferred).
  • Experience: Prior experience in clinical research or related field (1-3 years required).
  • Skills: Strong analytical, organizational, and communication skills; proficiency in clinical trial management software and data analysis tools.

Additional Requirements:

  • Certification: Certification (e.g., ACRP or SOCRA) preferred but not required.
  • Knowledge: Knowledge of the clinical trial process and regulatory guidelines.
  • Ability: Ability to work independently and as part of a team, prioritizing tasks and managing competing demands.

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