Clinical Research Associate, Sponsor Dedicated

đź•’ April 7

🏄 California, Kansas, +1 more states – Remote

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đź’µ $71.9k - $182k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

đź§Ş Clinical Research

🦅 H1B Visa Sponsor

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đź‘» Ghost score 45%

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Logo of IQVIA

IQVIA

10,000+ employees

đź’Ľ Consulting

🏭 Manufacturing

📣 Marketing

đź’° $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

đź“‹ Description

• Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits • Work with sites to adapt, drive, and track subject recruitment plans • Administer protocol and related study training to assigned sites • Establish regular communication with sites to manage project expectations and issues • Evaluate study-site practices for protocol quality, integrity, and regulatory adherence • Escalate quality issues as appropriate • Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution • Support the study start-up phase as needed • Ensure site documents are available for Trial Master File filing • Verify Investigator's Site File maintenance according to GCP/ICH and local requirements • Create and maintain site-management documentation, monitoring visit findings, and action plans • Submit visit reports and generate follow-up letters and required study documentation • Collaborate with study team members to support project execution • Support development of per-site subject recruitment plans when applicable • Support site financial management and retrieve invoices according to local requirements when applicable

🎯 Requirements

• 1-2 years of onsite monitoring experience • Expertise in Cardiovascular/Renal/Metabolic, Oncology, and/or Neurology • Bachelor's Degree in scientific discipline or health care preferred; marked as required in the posting • Equivalent combination of education, training and experience may be accepted in lieu of degree • Completion of CRA training program or prior monitoring experience may be required by some organizations • Basic knowledge of applicable clinical research regulatory requirements, including GCP and ICH guidelines • Good therapeutic and protocol knowledge as provided in company training • Proficiency in Microsoft Word, Excel, and PowerPoint • Experience using a laptop computer and iPhone/iPad where applicable • Good command of English language • Written and verbal communication skills • Organizational and problem-solving skills • Effective time and financial management skills • Ability to establish and maintain effective working relationships with coworkers, managers, and clients

🏖️ Benefits

• Health and welfare benefits • Incentive plans, bonuses, and/or other forms of compensation may be offered

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