Clinical Research Associate, Sponsor Dedicated

IQVIA; Crystal Lake (IL); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a Clinical Research Site Monitor to perform on-site monitoring, training, and data quality assurance across US sites. You will coordinate with sites, manage regulatory submissions, and maintain TMF/ISF in compliance with GCP and regulations.

Ideal candidates hold a Bachelor's degree in a scientific field or health care and have at least two years of on-site monitoring experience, with strong English communication and MS Office proficiency. Travel may be required.

Qualifications

• Bachelor's degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Excellent written and verbal English communication.
• Proficiency with MS Word, Excel and PowerPoint.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP.
• Coordinate with sites to adapt and track subject recruitment plans to improve predictability.
• Provide protocol training and establish regular communication with sites to manage expectations and issues.
• Assess site practices for protocol conduct and regulatory adherence; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion/submission, and data queries; may support start-up.
• Maintain TMF/ISF documentation per GCP and regulatory requirements.
• Document site management, visit findings and action plans; submit reports and follow-up letters.
• Collaborate with study teams to support project execution.
• Support development of site-specific recruitment plans.
• Assist site financial management and invoicing per contract.

Skills

On-site monitoring

GCP/ICH knowledge

English language

MS Word / PowerPoint

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Durham, North Carolina, United States of America

Aurora, Illinois, United States

San Fernando, California, United States

Clinton, Missouri, United States

Mansfield, Ohio, United States

Santa Cruz, California, United States

Santa Fe, New Mexico, United States

South Shore, Illinois, United States

Elk Grove, California, United States

Hudson, Ohio, United States

Englewood, Colorado, United States

Bellingham, Washington, United States

Marysville, Washington, United States

Overland Park, KS, United States of America

Evanston, Wyoming, United States

La Habra, California, United States

Prescott, Arizona, United States

Westchester, New York, United States

Mount Vernon, Illinois, United States

Warren, Ohio, United States of America

Linden, New Jersey, United States

Fremont, California, United States

Del Mar, California, United States

Lake Tahoe, California, United States

Northfield, New Jersey, United States

Fort Pierce, Florida, United States

Wilkes Barre, Pennsylvania, United States

Camden, New Jersey, United States

Lancaster, California, United States

Clarksville, Tennessee, United States

Adair, Iowa, United States

Fort Collins, Colorado, United States

Breckenridge, Colorado, United States

Littleton, Colorado, United States

Liverpool, New York, United States

Ft Lauderdale, Florida, United States

Springfield, Ohio, United States

Long Island, New York, United States

Gloucester, Virginia, United States

West Point, Virginia, United States

O'Fallon, Illinois, United States

Cheyenne, Wyoming, United States

Manhattan, New York, United States

New City, New York, United States

Parsippany, New Jersey, United States of America

Queens, New York, United States

New York City, New York, United States

Escondido, California, United States

Oak Brook, Illinois, United States

Merritt Island, Florida, United States

El Cajon, California, United States

Ontario, California, United States

Afton, Wyoming, United States

Abilene, Texas, United States

Orangevale, California, United States

Abingdon, Virginia, United States

Orland Park, Illinois, United States

Shenandoah, Texas, United States

Akron, Ohio, United States

Paradise Valley, Arizona, United States

Newark, Delaware, United States

Hollywood, Florida, United States

Port Saint Lucie, Florida, United States

Lawton, Oklahoma, United States

Portland, Oregon, United States

Chino Hills, California, United States

Belmar, New Jersey, United States

Sonora, California, United States

Berkley, California, United States

Springfield, Massachusetts, United States

Springfield, Missouri, United States

San Jose, California, United States

Beverly Hills, California, United States

Melbourne, Florida, United States

Colorado Springs, Colorado, United States

St. Petersburg, Florida, United States

Panama City, Florida, United States

Redondo Beach, California, United States

Crystal Lake, Illinois, United States

Rochester, New York, United States

Ada, Oklahoma, United States

Kansas City, Missouri, United States

Ainsworth, Nebraska, United States

Carlsbad, CA, United States of America

Denver , Colorado, United States

Full time

R1541733

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

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 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 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 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.
• 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.
• Requires at least 2 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good 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

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 $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.

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