Senior Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Take charge of study start-up activities for multi-center US and/or global studies independently.

• Conduct on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as necessary to evaluate site and CRA performance.

• Provide oversight for monitoring by reviewing schedules, metrics, and reports.

• Facilitate clinical site training and ensure compliance with protocols, relevant GCP/ICH guidelines, regulations, statutes, and SOPs.

• Lead or engage in vendor management activities, including those involving Central Laboratory, Central Imaging, and CRO vendors.

• Perform routine data listings review in-house.

• Gather, review, and oversee regulatory documentation for study start-up, maintenance, and close-out processes.

• Assist CTM and cross-functional representatives with contracts, study logistics, patient enrollment, safety, and data management.

• Mentor and guide junior Clinical Research staff, including Clinical Trial Assistants.

• Aid in protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study documentation.

• Help manage and/or lead day-to-day operations of assigned studies in line with GCP/ICH and regulatory standards.

• Execute other tasks and assignments necessary for project success.

• Uphold Iovance Biotherapeutics’ core values, policies, procedures, and ethical standards.

• Undertake miscellaneous duties as assigned.

⛳️ Requirements

• Bachelor’s degree (BS/BA), RN, or equivalent with a minimum of 4 years in clinical trial monitoring/management and vendor experience in compliance with CFR, GCP, and ICH Guidelines.

• Over 8 years of experience in clinical operations.

• Background in Solid Tumor or Cell Therapy.

• Strong understanding of ICH/GCP guidelines.

• In-depth knowledge of protocol and clinical drug development processes, clinical study design, study planning, management, and monitoring.

• Significant experience managing clinical studies from early to late phases and collaborating with CROs and other study vendors.

• Exceptional interpersonal, written, and verbal communication skills, along with strong administrative and computer skills.

• Excellent organizational abilities, record retention, time management, decision-making, customer service, and interpersonal skills.

• Proficient command of writing and speaking in English.

• Advanced computer skills in MS Word, PowerPoint, Excel, and Project.

• Capability to remain in a stationary position (standing or sitting) for extended periods.

• Ability to navigate within an office and exert up to 10 pounds of force occasionally or negligible force frequently or consistently.

• Visual acuity for preparing and analyzing data and figures, viewing a computer screen, and extensive reading.

• Ability to perform repetitive motions involving the wrist, hands, and/or fingers.

• Skill in communicating with others to exchange information.

• Clear and conceptual thinking abilities; excellent judgment, troubleshooting, problem-solving, analytical skills, and discretion.

• Capability to manage work-related stress, multiple priorities, and deadlines.

• Willingness to travel up to 25%.

🏝️ Benefits

• Reasonable accommodations may be provided upon request.

• A diverse and inclusive work environment.

• Equal-opportunity employment.