Senior Clinical Research Associate
About The Position
The Senior Clinical Research Associate is a critical in-house role on Iovance’s clinical team. Working closely with the Clinical Trial Manager and/or Study Director, this position provides operational management and daily oversight of study timelines, deliverables, and the performance of CROs and study vendors. Site activity is overseen remotely, and occasionally on site, through CRO monitoring reports and metrics. The role partners with the Medical Monitor and internal and external constituents to ensure clinical trial activities and deliverables are completed on time and in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company SOPs. The Senior CRA supports and manages study start-up, monitoring oversight, vendor coordination, regulatory documentation, data review, and day-to-day study operations. The position also contributes to study plans and clinical operations processes, maintains Trial Master File quality and inspection readiness, and prepares status updates for clinical leadership and cross-functional teams. The role may include other duties as required by project and organizational needs.
Requirements
- BS/BA, RN, or equivalent.
- At least 4 years of clinical trial management, clinical operations, and vendor oversight experience in a sponsor or CRO setting, in accordance with CFR, GCP, and ICH guidelines.
- At least 8 years of clinical operations experience.
- Experience in solid tumors or cell therapy.
- Strong knowledge of ICH/GCP guidelines.
- Strong knowledge of protocols, clinical drug development processes, clinical study design, study planning and management, and monitoring.
- Strong experience managing early- to late-phase clinical studies and working with CROs and other study vendors.
- Excellent interpersonal, written and verbal communication, administrative, and computer skills; good command of written and spoken English.
- Excellent organizational, record-retention, time-management, decision-making, customer-service, and interpersonal skills.
- Excellent computer skills in MS Word, PowerPoint, Excel, and Project.
- Ability to contribute individually to a research and development effort.
- Ability to meet the described physical and mental demands, with reasonable accommodation available upon request.
Nice To Haves
- Prior on-site CRA monitoring experience is a plus but is not required.
- Experience with eTMF and CTMS systems is preferred.
- Experience tracking CRO/vendor budgets and invoices is preferred.
Responsibilities
- Independently manage start-up activities for multicenter U.S. and/or global studies.
- Review and track CRO monitoring visit reports, follow-up letters, and action items; assess site and CRA performance trends and escalate issues to the Clinical Trial Manager.
- Oversee monitoring by reviewing schedules, metrics, reports, KPIs and KRIs, enrollment and site activation tracking, protocol deviations, and issue resolution.
- Support clinical site and CRO training by reviewing materials and tracking completion; oversee adherence to protocol, applicable GCP/ICH guidelines, regulations, statutes, and SOPs through CRO reports and metrics.
- Lead or participate in day-to-day vendor management, including deliverable and timeline tracking, change orders, and invoice and budget reconciliation support.
- Perform routine in-house data listings review.
- Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and close-out.
- Serve as a Clinical Trial Manager delegate and coordinate study activities with cross-functional representatives on contracts, logistics, enrollment, safety, data management, and related matters.
- Contribute to study timelines, risk logs, meeting agendas, and minutes.
- Mentor and coach junior staff new to clinical research, such as Clinical Trial Assistants.
- Assist with developing protocols, informed consents, CRFs, monitoring conventions, tracking forms, and other study documents.
- Assist in managing and/or leading day-to-day operations of assigned studies to meet project team goals and objectives and comply with applicable GCP/ICH guidelines and other regulatory requirements.
- Maintain and perform quality review of the Trial Master File and support inspection readiness activities.
- Contribute to the development and maintenance of study-level plans, including monitoring, communication, and risk management plans, and to clinical operations process and SOP improvement.
- Prepare study status updates and presentations for clinical leadership and cross-functional study team meetings.
- Travel up to 25%.
- Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics; perform other assigned duties as required.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
