Job Overview:
The role involves overseeing and managing clinical trials and research studies to evaluate new drugs, treatments, or medical devices. This position requires collaboration with healthcare professionals, regulatory bodies, and study sponsors to ensure compliance and integrity in research.
Key Responsibilities:
- Study Management: Plan, initiate, and monitor clinical trials from start to finish.
- Site Selection and Training: Identify and recruit study sites; provide training and support to site staff.
- Regulatory Compliance: Ensure adherence to Good Clinical Practice (GCP), regulatory requirements, and study protocols.
- Data Collection and Analysis: Oversee data collection processes and ensure data integrity and accuracy.
- Patient Interaction: Engage with study participants, including informed consent processes and follow-ups.
- Documentation: Maintain thorough and accurate study documentation, including trial master files and regulatory submissions.
- Collaboration: Work with cross-functional teams, including PIs, medical writers, and regulatory affairs.
- Reporting: Prepare and present study progress reports and findings to stakeholders.
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 (e.g., ACRP or SOCRA) preferred but not required.
- Knowledge of the clinical trial process and regulatory guidelines.
- Ability to work independently and as part of a team.
