Oncology Clinical Research Associate

About the Role

IQVIA is hiring Clinical Research Associates (CRA) at the 1 and 2 level. Candidates are required to have 6 months to 2 years of onsite monitoring experience within oncology. A preference for Cardiovascular/Renal/Metabolic, and/or Neurology experience is noted. Candidates can be located anywhere in the US.

Job Overview

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.

Key Responsibilities

• 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/originals (as required) site documents are available for filing in the Trial Master File (TMF). Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP/ICH 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.

Requirements & Tech Stack

• Onsite monitoring experience within oncology (6 months to 2 years).
• Preference for Cardiovascular/Renal/Metabolic, and/or Neurology experience.
• Good Clinical Practice (GCP) knowledge.
• International Conference on Harmonization (ICH) guidelines knowledge.
• Microsoft Word, Excel, and PowerPoint proficiency.
• Laptop computer, iPhone, and iPad usage.

Qualifications

• Bachelor's Degree in a scientific discipline or health care is preferred.
• Equivalent combination of education, training, and experience may be accepted in lieu of a degree.
• Some organizations require completion of CRA training program or prior monitoring experience.
• Basic knowledge of and skill in applying applicable clinical research regulatory requirements (GCP and ICH guidelines).
• Good therapeutic and protocol knowledge (as provided in company training).
• Written and verbal communication skills including good command of the 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.