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Clinical Trial Operations Specialist

2 months ago

Bellaire, Texas, United States Pinnacle Clinical Research Full time
Overview:
At Pinnacle Clinical Research, we are dedicated to pioneering advancements in medical science through exceptional clinical trials. Our mission is to foster innovation and enhance healthcare through meticulous research studies that aim to unveil breakthroughs capable of revolutionizing patient treatment and enhancing quality of life. We emphasize the significance of clinical research in shaping the future of healthcare.

Position Summary:
Pinnacle Clinical Research is seeking a Clinical Research Coordinator I who will oversee the daily functions of assigned clinical trials, assist in project development, and ensure adherence to established protocols and regulatory standards. This role involves engaging in meetings and events to promote studies, recruit and screen participants, and meticulously document the progress of studies and participant status. The ideal candidate will possess the ability to prioritize clinical trial tasks and establish an efficient workflow to meet all necessary deadlines. This position entails handling a variety of responsibilities involving sensitive information.

Key Responsibilities:
  • Manage daily operations of clinical trials while adhering to protocols and regulatory guidelines.
  • Maintain confidentiality of subjects and documents, ensuring compliance with sponsor requirements and regulations.
  • Conduct patient assessments, including informed consent and health evaluations.
  • Prepare and manage study-related documentation and liaise with pharmaceutical sponsors.
  • Coordinate study monitor visits and respond to information requests promptly.
  • Facilitate subject recruitment and screening processes.
  • Contribute to data management and identify opportunities for enhancing patient care.
  • Conduct patient interactions with empathy and thoroughness.
  • Ensure timely transcription of source documents to electronic data capture systems.
  • Engage with internal and external stakeholders, including medical professionals and study participants.

Administrative Duties:
  • Complete electronic case report forms and maintain study documentation.
  • Prepare reports and ensure timely entry of patient data into management systems.
  • Understand and comply with regulatory and institutional review board requirements.
  • Assist in quality assurance processes and corrective action plans as necessary.

Qualifications:
  • High school diploma or GED required; Bachelor's degree in a scientific field preferred.
  • Proficiency in Microsoft Office and clinical trial management systems.
  • Strong understanding of ICH/GCP guidelines.
  • Must complete necessary training and certifications prior to participant interaction.
  • Excellent organizational skills and attention to detail.
  • Strong written and verbal communication abilities.
  • Fluency in both Spanish and English is required.

Work Environment:
The work environment may include clinical and laboratory settings, with exposure to biological materials. Personal protective equipment is required, and the role may involve occasional travel. The position requires the ability to work in a stationary position for extended periods and perform light to moderate lifting.

Benefits:
  • Comprehensive health insurance options.
  • Retirement savings plan.
  • Paid time off and holidays.
  • Access to wellness facilities.

Pinnacle Clinical Research is an equal opportunity employer, committed to diversity and inclusion in the workplace.