CRA 2, Oncology, IQVIA

IQVIA; Wayne (PA); On-site; USD 87,200 - 145,300; Full time

Job summary

A leading healthcare data analytics firm in Pennsylvania is hiring a Clinical Research Associate. This role involves performing site monitoring visits, managing the progress of studies while ensuring adherence to regulatory requirements, and collaborating with study teams. Candidates should have a Bachelor’s degree in a scientific discipline or healthcare and 1.5 to 2 years of relevant CRA experience. The position offers a salary range from $87,200 to $145,300 annually depending on qualifications and experience.

Qualifications

• Bachelor’s Degree in a scientific discipline or healthcare preferred.
• 1.5 to 2 years of relevant CRA experience including on-site monitoring.

Responsibilities

• Perform site monitoring visits in accordance with GCP and ICH guidelines.
• Manage the progress of assigned studies by tracking regulatory submissions.
• Evaluate the quality and integrity of study site practices.

Skills

Site monitoring

Project management

GCP adherence

Data management

Education

Bachelor’s Degree in scientific or healthcare discipline

Job description

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 or originals (as required) of 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 requirements.

Education and Experience

• Bachelor’s Degree (degree in scientific discipline or health care preferred)
• 1.5 to 2 years of relevant CRA experience including on-site monitoring.

Compensation

The potential base pay range for this role, when annualized, is $87,200.00 - $145,300.00. 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.

Equal Opportunity Employment

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.