IQVIA’s sponsor-dedicated (cFSP) team is seeking a Lead Clinical Research Associate to join us on our mission to help create a healthier world.
The Lead CRA’s responsibilities include assessing qualifications of potential clinical study sites, implementing clinical studies at participating sites, managing the conduct of clinical studies at sites, ensuring the quality of site performance and closing clinical studies.
The Lead CRA will ensure that clinical trials are conducted according to the approved protocol/protocol amendments and comply with Good Clinical Practice (GCP), Company SOPs, and all applicable regulatory requirements. They will contribute to the determination, development, and/or implementation of efficient and effective approaches to study site management.
Apply today and forge a career with greater purpose, make an impact, and never stop learning!
Key Responsibilities
* Evaluate, initiate, monitor, and close out clinical study sites. Document all activities in clear, comprehensive, and accurate Monitoring Visit Reports, Contact Reports, and follow-up letters within required timelines.
* Ensure that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements.
* Train/retrain site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial.
* Serve as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.
* Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.
* Ensure subjects’ rights, safety, and well-being are protected.
* Ensure compliance with the procedures to apply in the event of adverse events and serious adverse events.
* Evaluate the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion.
* Assist Data Management in development, review, and/or testing of eCRFs and eCRF Completion Guidelines. Support data validation and data cleaning procedures to ensure timelines are met.
* Identify, assess, and resolve site performance, quality, or compliance problems and develop an appropriate intervention plan for the avoidance of redundant errors and deviations.
* Communicate with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
* Maintain audit-ready clinical trial documentation. Collect, review, monitor, and file required regulatory documentation during study maintenance and at study closeout. Verify investigator study records are reconciled with the contents of Sponsor files (Trial Master File).
* Verify the receipt, handling, accounting, storage conditions, and availability of study medications under investigation.
* Ensure availability of non-clinical materials for sites.
* Demonstrate strong site relationships and ensure continuity of site relationships through all phases of the trial.
* Demonstrate an in-depth understanding of study protocols and related procedures.
* Contribute to CRA team knowledge by acting as process and/or system Subject Matter Expert (SME), sharing best practices; developing new processes, when needed; making recommendations for continuous improvement.
* Provide training/coaching/mentoring to other CRAs as needed.
* Assist in developing presentations for internal team and Investigator meetings.
* Assume responsibility for and independently complete special projects, if assigned, with minimal monitoring management guidance.
Requirements
* Minimum 5 years of experience in the pharmaceutical/biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock.
* Strong Oncology monitoring experience in phase 1-3 pharmaceutical/biotechnology clinical trials and demonstrated high level of monitoring skill with independent professional judgment.
* Ability to work highly independently across multiple studies, projects, and sites. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific, and medical information.
* Work with a high quality and compliance mindset.
* Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem-solving, attention to detail, and interpersonal skills.
* Demonstrated ability to mentor/lead.
* Possess excellent understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant local regulatory requirements.
* Strong knowledge of concepts of clinical research and drug development.
* Strong working knowledge of EDC, IVRS, and CTMS systems and proficient in the use of Microsoft Office.
* Must be willing to travel (8-10 days/month on site) and possess a valid UK driving license.
*Please note - this role is not eligible for UK visa sponsorship*
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