Job Overview
Conduct monitoring and site management tasks across various protocols, sites, and therapeutic areas.
Key Responsibilities
- Site Monitoring Visits: Carry out site monitoring visits (selection, initiation, monitoring, and close-out) in line with the contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Subject Recruitment: Collaborate with sites to adapt, drive, and track subject recruitment plans to meet project needs and improve predictability.
- Protocol Administration: Provide protocol and study-related training to assigned sites and maintain regular communication to manage ongoing project expectations and issues.
- Quality Evaluation: Assess the quality and integrity of study site practices related to protocol adherence and regulatory compliance. Escalate quality issues as necessary.
- Study Progress Management: Oversee the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query resolution. May assist with the start-up phase.
- Document Management: Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained according to GCP/ICH and local regulatory requirements.
- Documentation: Create and maintain documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation.
- Mentorship: Act as a mentor for clinical staff, including conducting co-monitoring and training visits.
- Collaboration: Work with study team members to support project execution as needed.
- Recruitment Plan Development: If applicable, support the development of project subject recruitment plans on a per-site basis.
- Financial Management: If applicable, manage site financials according to the clinical trial agreement and retrieve invoices as required by local regulations.
Qualifications
- Education: Bachelor's degree in a scientific discipline or healthcare preferred.
- Experience: At least 1.5 years of on-site monitoring experience required. Equivalent combinations of education, training, and experience may be considered.
- Regulatory Knowledge: In-depth knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
- Therapeutic and Protocol Knowledge: Strong understanding of therapeutic areas and protocols as provided in company training.
- Technical Skills: Proficiency in Microsoft Word, Excel, and PowerPoint, and the use of a laptop computer and iPhone/iPad (where applicable).
- Communication Skills: Strong written and verbal communication skills, with a good command of the English language.
- Organizational Skills: Effective organizational and problem-solving abilities.
- Time and Financial Management: Strong time and financial management skills.
- Interpersonal Skills: Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.