Job Title: Clinical Research Coordinator

Work Set-Up: On-site
Schedule: 24 hours per week

About IQVIA

IQVIA is a global leader in advanced analytics technology solutions and clinical research services dedicated to driving healthcare forward. We partner with the worlds leading pharmaceutical biotechnology and medical device companies to improve patient outcomes and accelerate innovation. Our team combines deep scientific expertise with cutting-edge technology to deliver high-quality data and insights that shape the future of clinical trials.

Responsibilities:

• Perform a variety of complex clinical procedures on subjects including but not limited to ECG sample collection (including spirometry) and vital signs.
• Phlebotomy is required; pediatric experience is preferred.
• Participate in community outreach as part of recruitment efforts.
• Coordinate clinical research studies conducted by a supervising Principal Investigator.
• Maintain and update skills training and knowledge of current best nursing practices and clinical research topics.
• Safeguard the well-being of subjects and uphold high standards:
  • Maintain a safe environment in accordance with Health and Safety policies.
  • Act as a volunteer advocate and address concerns proactively.
  • Assist staff in clinical coordinator practices and care delivery.
  • Report any deviation from normal practice to senior staff.

Support Study Conduct By:

• Reviewing study protocols CRFs and electronic data capture systems.
• Participating in project meetings as needed.
• Performing clinical set-up and preparation for studies including labeling specimen tubes setting up equipment and preparing documents.
• Planning logistical activities for procedures per protocol.
• Generating volunteer instructions and preparing study-specific training materials.
• Troubleshooting study issues and participating in daily huddles to ensure task execution.
• Assisting with data quality checks and query resolution to ensure protocol adherence.
• Recruiting and screening volunteers based on pre-determined criteria.
• Orienting volunteers to the study and site including timelines and procedures.
• Administering and maintaining custody of study drugs per SOPs.
• Collecting recording and reporting clinical data accurately in CRFs.
• Collaborating with investigators on adverse events and serious adverse events reporting.
• Cooperating with study monitors and following ICH GCP guidelines for all activities.

Qualifications:

• High School Diploma and at least 1 year of relevant clinical research experience (or equivalent education and experience).
• At least 1 year in a clinical research setting preferred.
• Applicable certifications and licenses as required by company country state and/or regulatory bodies.
• Working knowledge of clinical trials and Good Clinical Practices (GCP).
• In-depth knowledge of protocol-specific procedures consent forms and study schedules.
• Skill in performing required clinical procedures and familiarity with medical terminology.
• Strong attention to detail and ability to maintain effective working relationships with coworkers managers patients physicians and clients.

Additional Qualification:

• Recruitment: Experience in prescreening (chart review referral management and community outreach) scheduling appointments visit/activity reminder calls supporting patient education and check-ins pre-visit education and set-up (including lab kits and equipment) documentation for visits collection of concomitant medications/adverse events/serious adverse events PI reminders for trial-level activities calibration certificates for equipment data entry for recruitment Investigator Site File maintenance (document support prior to trial consent).

Please note: This position is not eligible for sponsorship.

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