Clinical Research Associate, Sponsor Dedicated

Clinical Research Associate, Sponsor Dedicated

Akron, United States of America | Full time | Field-based | R1541733

To be eligible for this position, you must reside in the same country where the job is located.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close‑out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution; may support start‑up phase.
• Ensure copies/originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• 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.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per‑site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree in a scientific discipline or health care preferred.
• At least 2 years of on‑site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of a degree.
• Good knowledge of and skill in applying applicable clinical research regulatory requirements, including GCP and ICH guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in Microsoft Word, Excel and PowerPoint and use of a laptop computer, iPhone and iPad (where applicable).
• Written and verbal communication skills, good command of English language.
• Organizational and problem‑solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Potential base pay range: $71,900.00 – $189,000.00 annualized. Compensation may vary based on qualifications, location, schedule and may include incentive plans, bonuses and other benefits.

Equal Opportunity Employment

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.