Clinical Research Associate, Sponsor Dedicated

IQVIA; Springfield (MA); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services and healthcare insights. This role focuses on on-site monitoring to ensure protocol adherence, data integrity, and regulatory compliance across study sites in the United States.

Qualified candidates have a science-related Bachelor's degree and at least 2 years of on-site monitoring experience, with strong English communication skills and proficiency in MS Word, Excel and PowerPoint.

Qualifications

• Bachelor's Degree in a scientific discipline or health care.
• Minimum 2 years of on-site monitoring experience.
• Knowledge of GCP and ICH guidelines.
• Proficiency with MS Word, Excel and PowerPoint; laptop/iPhone/iPad usage.
• Strong written and verbal English communication.
• Excellent organizational and time-management skills.
• Ability to collaborate with cross-functional teams.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP.
• Collaborate with sites to drive recruitment plans and improve predictability.
• Administer protocol training and maintain communication with sites.
• Assess site practices for protocol compliance and escalate issues.
• Track regulatory submissions, recruitment, CRFs, data queries; may support start-up.
• Maintain TMF/ISF documentation and file site materials per requirements.
• Prepare visit reports and follow-up letters; coordinate with study team.

Skills

On-site monitoring

GCP knowledge

English proficiency

Time management

Organizational skills

Regulatory compliance

Education

Bachelor's degree

Tools

MS Word

MS Excel

MS PowerPoint

Mobile device usage (iPhone/iPad)

Job description

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 athttps://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.