CRA 2, Oncology, IQVIA

IQVIA; Boston (MA); On-site; USD 87,200 - 145,300; Full time

Job summary

A leading clinical research organization is seeking a CRA 2 in Boston, MA, with at least 1.5 years of on-site oncology monitoring experience. The role includes monitoring site preparation, ensuring compliance with regulations, and managing documents required for study management. Candidates must hold a relevant Bachelor's degree and possess strong communication and project management skills. Competitive pay range between $87,200 and $145,300 based on experience and qualifications is offered.

Qualifications

• Minimum 1.5 years of on-site oncology monitoring experience.
• Experience with Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.

Responsibilities

• Perform site monitoring visits in accordance with regulatory requirements.
• Manage progress of assigned studies by tracking submissions and approvals.
• Evaluate site practices related to proper conduct of the protocol.

Skills

On-site oncology monitoring experience

Knowledge of GCP and ICH guidelines

Strong communication skills

Education

Bachelor’s Degree in scientific discipline or healthcare

Job description

IQVIA is seeking a CRA 2 with a minimum of 1.5 years of on‑site oncology monitoring experience:

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 Harmonisation (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 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.

Education

Bachelor’s Degree (Degree in scientific discipline or health care preferred)

Experience

1.5 to 2 years of relevant CRA experience including on‑site monitoring.

Pay & Benefits

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.

EEO Statement

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. EEO Minorities/Females/Protected Veterans/Disabled