(Senior) Clinical Research Associate - Sponsor Dedicated

IQVIA; Carlsbad (CA); On-site; USD 71,000 - 189,000; Full time

Job summary

An established industry player is seeking a dedicated Clinical Research Associate to ensure the integrity of clinical studies. In this pivotal role, you will perform site monitoring visits, manage study progress, and ensure compliance with regulatory requirements. You'll collaborate with study teams and mentor clinical staff, all while contributing to the advancement of innovative medical treatments. This is an exciting opportunity to join a forward-thinking company committed to improving patient outcomes and population health. If you are passionate about clinical research and thrive in a dynamic environment, we invite you to apply and make a significant impact.

Qualifications

• 4+ years of on-site monitoring experience required.
• Knowledge of GCP and ICH guidelines is essential.
• Strong communication and organizational skills are crucial.

Responsibilities

• Conduct site monitoring visits and ensure compliance with study protocols.
• Manage study progress and track regulatory submissions.
• Mentor clinical staff and maintain effective communication with sites.

Skills

On-site monitoring experience

Good Clinical Practice (GCP)

International Conference on Harmonization (ICH)

Organizational skills

Problem-solving skills

Communication skills

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Laptop

iPhone

iPad

Job description

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

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• 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 the 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 (as required) 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 / ICH and local regulatory requirements.

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

• Act as a mentor for clinical staff including conducting co-monitoring and training visits.

• 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 Degree in scientific discipline or health care preferred. Req

• Requires at least 4 years of year of on-site monitoring experience.

• Equivalent combination of education, training and experience may be accepted in lieu of degree.

• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Strong therapeutic and protocol knowledge as provided in company training.

• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).

• Written and verbal communication skills including 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.

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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled