IQVIA’s sponsor-dedicated (cFSP) team are 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.
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Key Responsibilities
Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines.Ensures 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.Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial.Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.Ensures subjects’ rights, safety and well-being are protected.Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events.Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion.Assists Data Management in development, review and/or testing of eCRFs and eCRF Completion Guidelines. Also supports data validation and data cleaning procedures to ensure timelines are met.Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate intervention plan for the avoidance of redundant errors and deviations.Communicates 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.Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeout. Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File).Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation.Ensures availability of non-clinical materials for sites.Demonstrates strong site relationships and ensures continuity of site relationships through all phases of the trial.Demonstrates an in-depth understanding of study protocols and related procedures.Contributes to CRA team knowledge by acting as process and/or system Subject Matter Expert (SME), sharing best practices; developing new process(es), when needed; making recommendations for continuous improvement.Providing training/coaching/mentoring to other CRAs as needed.Assists in developing presentations for internal team and Investigator meetings.Assumes responsibility of and independently completes 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 judgmentAbility 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.Works with 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 on 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.#LI-ADAMTHOMPSON
*Please note - this role is not eligible for UK visa sponsorship*
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