Clinical Research Associate, Sponsor Dedicated

IQVIA Argentina; Carlsbad (CA); Remote; USD 71,000 - 189,000; Full time

Job summary

An established industry player is seeking Clinical Research Associates to join their dynamic team. This role involves monitoring and managing clinical trials, ensuring compliance with regulatory standards, and supporting site recruitment efforts. Ideal candidates will possess a strong background in clinical research, excellent communication skills, and the ability to work collaboratively with various stakeholders. This position offers the opportunity to contribute to innovative medical treatments that enhance patient outcomes and health worldwide. If you are passionate about making a difference in the healthcare sector, this role is perfect for you.

Qualifications

• Bachelor's degree in a scientific discipline or healthcare preferred.
• Minimum of on-site monitoring experience required.
• Strong knowledge of clinical research regulatory requirements.

Responsibilities

• Perform site monitoring visits and ensure compliance with protocols.
• Evaluate quality and integrity of site practices and escalate issues.
• Manage study progress and maintain documentation for site management.

Skills

Clinical Research Monitoring

Regulatory Compliance (GCP, ICH)

Microsoft Office Suite

Communication Skills

Organizational Skills

Problem-Solving Skills

Time Management

Education

Bachelor's Degree in Scientific Discipline or Healthcare

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

iPhone

iPad

Job description

Our team is looking for Clinical Research Associates to join our Sponsor Dedicated team. Ideal candidates can be located anywhere in the US near a major airport hub. Oncology experience preferred.

Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

1. Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
2. Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
3. Administer protocol and related study training to assigned sites and establish regular communication with sites to manage ongoing project expectations and issues.
4. 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.
5. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution. Support start-up phase if applicable.
6. 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 and local regulatory requirements.
7. Create and maintain documentation regarding site management, monitoring visit findings, and action plans by submitting reports, follow-up letters, and other documentation.
8. Collaborate with study team members for project execution support as appropriate.
9. If applicable, support development of project subject recruitment plans and site financial management according to clinical trial agreements.

Qualifications

• Bachelor's Degree in a scientific discipline or healthcare preferred.
• At least months of on-site monitoring experience required.
• Equivalent combination of education, training, and experience may be accepted in lieu of degree.
• Good 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, PowerPoint, and familiarity with using a laptop, iPhone, and iPad (where applicable).
• Strong written and verbal communication skills in English.
• Organizational and problem-solving skills.
• Effective time and financial management 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, veteran status, or any other protected status.

The potential base pay range for this role, when annualized, is $71,900 - $189,000. Actual offers may vary based on qualifications, location, schedule, and other factors. Additional incentives, bonuses, and benefits may be offered.