Clinical Research Associate - Sponsor Dedicated

IQVIA; Tampa (FL); Vor Ort; USD 75.000 - 198.000; Vollzeit

Zusammenfassung

IQVIA is actively seeking experienced Clinical Research Associates II (CRA II) and Senior Clinical Research Associates (Sr. CRA) to support a range of clinical studies across multiple therapeutic areas nationwide.

In this role, you will oversee clinical trial sites to ensure studies are conducted in compliance with study protocols, regulatory requirements, GCP and ICH guidelines, and sponsor expectations. Strong site management and communication skills are essential.

Qualifikationen

• Bachelor’s degree in Life Sciences, Healthcare, Nursing, or a related field preferred; related experience may be considered.
• Minimum of 2 years of independent on-site monitoring experience in pharma/biotech/CRO.
• Strong knowledge of GCP and ICH guidelines; proficient in Microsoft Office and EDC tools.

Aufgaben

• Conduct site monitoring visits across all study phases, including initiation, routine monitoring, and close-out.
• Evaluate site performance for protocol adherence, GCP, ICH, and regulatory compliance.
• Develop and track patient recruitment/retention strategies to support enrollment goals.
• Provide protocol-specific training and maintain clear communication with site staff.
• Identify and document quality or compliance concerns and support timely resolutions.
• Monitor regulatory submissions, approvals, enrollment metrics, CRF completion, and data queries.
• Ensure study documents are complete and filed in TMF/ISF.
• Prepare monitoring reports and required study documentation per standards.
• Collaborate with project teams to support study execution and milestones.
• Possible participation in study start-up, site budgeting, and payments depending on assignment.

Kenntnisse

Site monitoring

GCP/ICH knowledge

Communication skills

Ausbildung

Bachelor’s degree in Life Sciences or related field

Jobbeschreibung

Clinical Research Associate II & Senior Clinical Research Associate (CRA II/Sr. CRA) Multiple Therapeutic Areas | Nationwide Opportunities IQVIA is actively seeking experienced Clinical Research Associates II (CRA II) and Senior Clinical Research Associates (Sr. CRA) to support a range of clinical studies across multiple therapeutic areas nationwide. This is an exciting opportunity to join a global leader in clinical research and play a vital role in advancing innovative therapies that improve patient outcomes.

In this role, you will be responsible for overseeing clinical trial sites to ensure studies are conducted in compliance with study protocols, regulatory requirements, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and sponsor expectations. Successful candidates will possess strong site management skills, a commitment to quality, and the ability to build productive relationships with investigators and site personnel.

Key Responsibilities

• Conduct all phases of site monitoring activities, including site selection, initiation, routine monitoring, and close-out visits.
• Evaluate site performance and ensure adherence to study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
• Partner with investigative sites to develop, implement, and track patient recruitment and retention strategies that support enrollment goals.
• Deliver protocol-specific training and maintain ongoing communication with site staff to ensure alignment on study expectations and timelines.
• Identify, document, and elevate quality or compliance concerns while supporting timely resolution of issues.
• Monitor study progress by tracking regulatory submissions, approvals, enrollment metrics, CRF completion, and data query resolution.
• Ensure essential study documentation is complete, accurate, and maintained within the Trial Master File (TMF) and Investigator Site File (ISF).
• Prepare comprehensive monitoring reports, follow-up letters, and other required study documentation in accordance with company and sponsor standards.
• Collaborate cross-functionally with project teams to support study execution and achievement of project milestones.
• May participate in study start-up activities, site budget tracking, financial management, and site payment processes, depending on assignment.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, Nursing, or a related field preferred. Relevant education and professional experience may be considered in lieu of a degree.
• Minimum of 2 years of independent on-site monitoring experience within the pharmaceutical, biotechnology, or CRO industry.
• Strong understanding of clinical research processes and regulatory requirements, including GCP and ICH guidelines.
• Knowledge of therapeutic areas and clinical trial protocols gained through industry experience and training.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint, as well as mobile and electronic data capture technologies.
• Excellent verbal and written communication skills with the ability to effectively interact with investigators, site personnel, sponsors, and internal stakeholders.
• Strong organizational, problem-solving, and time management skills with the ability to manage multiple priorities in a fast-paced environment.
• Demonstrated ability to work independently while maintaining strong collaborative relationships with colleagues, clients, and study teams.

Join IQVIA and contribute to groundbreaking research while advancing your career with a global leader in healthcare and clinical development. Qualified candidates with experience across a variety of therapeutic areas are encouraged to apply.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $74,500.00 - $197,500.00. 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.