Clinical Research Associate, Sponsor Dedicated

IQVIA; Ainsworth (NE); Sur place; USD 75 000 - 198 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Research Associate to perform monitoring and site management to ensure compliant conduct of studies and timely data reporting.

The role involves site initiations, monitoring visits, recruitment tracking, training delivery, and maintaining TMF/ISF per GCP and regulatory standards. Strong English, regulatory knowledge, and experience with EDC/CTMS are required.

Qualifications

• Bachelor's degree in a scientific discipline or healthcare preferred.
• Minimum 2 years of independent on-site monitoring experience as a CRA in a CRO, sponsor, or similar setting.
• Knowledge of GCP/ICH guidelines and applicable regulatory requirements.
• Proficiency with Microsoft Word, Excel and PowerPoint.
• Experience using EDC, CTMS, eTMF, IVRS/IWRS in monitoring activities.
• Excellent written and verbal English communication.
• Strong organizational, problem-solving and time-management skills.

Responsabilités

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) per scope of work and GCP.
• Collaborate with sites to drive and track subject recruitment plans to meet project needs.
• Administer protocol training to sites and maintain regular communication to manage expectations and issues.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion, data queries; may support startup.
• Maintain trial master file and ISF per regulatory requirements.
• Document site management activities and generate reports and follow-up letters.

Connaissances

English proficiency

Communication skills

Organizational skills

Problem-solving

Time management

Financial management

Client relationship

Team collaboration

Formation

Bachelor's degree in scientific discipline or healthcare

Equivalent combination of education, training and experience

Outils

EDC

CTMS

eTMF

IVRS/IWRS

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Description du poste

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 independent on-site monitoring experience as a Clinical Research Associate (CRA) in a CRO, sponsor, or similar setting.
• 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).
• Must have experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems in support of monitoring activities.
• 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 $74,500.00 - $197,500.00. 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.