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Lead Clinical Research Specialist
hace 3 meses
Join IQVIA Biotech as a Lead Clinical Research Specialist. We are seeking a dedicated professional with diverse therapeutic expertise who is eager to engage in various therapeutic areas such as Oncology, Cardiovascular, Internal Medicine, and Ophthalmology. This position is designed to be home-based.
KEY RESPONSIBILITIES:
The Lead Clinical Research Specialist will:
- Participate in the planning and execution of clinical trials across Phases I-IV.
- Oversee the advancement of clinical studies by conducting site evaluations, initiating studies, and performing interim close-out visits.
- Ensure compliance with Good Clinical Practices and IQVIA Biotech protocols during monitoring activities.
- Collaborate closely with the Clinical Trial Manager (CTM) and/or Lead CRA to guarantee all monitoring tasks align with study specifications.
- Act as a mentor for junior CRAs and new team members, providing guidance and support.
ESSENTIAL FUNCTIONS:
- Engage in the investigator recruitment process and assess the capabilities of potential study sites.
- Work with the ISS department to facilitate the initiation of studies, ensuring all regulatory documentation is in place.
- Conduct study initiation activities, including protocol reviews and training site personnel on study procedures.
- Verify site compliance with Good Clinical Practices through regular monitoring visits and audits.
- Prepare comprehensive monitoring reports and ensure all clinical data is accurate and complete.
- Manage the accountability and storage of clinical trial materials, ensuring proper inventory practices.
- Facilitate communication between IQVIA Biotech and study sites, ensuring timely and effective data transmission.
- Participate in study close-out activities, including final reconciliations and resolution of outstanding issues.
QUALIFICATIONS:
- A degree in life sciences or a related field, with a minimum of four years of experience in clinical monitoring or site management.
- Strong understanding of clinical research processes and regulatory requirements.
- Excellent communication skills, both written and verbal, with the ability to convey complex information clearly.
- Proficiency in Microsoft Office Suite and familiarity with electronic data capture systems.
- Willingness to travel as required for site visits and meetings.
At IQVIA, we are committed to advancing human health through innovative research and data solutions. We value the contributions of our team members and strive to create a collaborative and supportive work environment.
