Senior Clinical Research Associate
New
I
Iovance BiotherapeuticsBiotechnology
RemoteFull-TimeSenior
Salary130,000 - 150,000 USD per year
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Job Details
- Languages
- English
- Experience
- 8+ years of clinical operations experience
- Required Skills
- Project ManagementMicrosoft Office
Requirements
- BS/BA, RN, or equivalent degree.
- 8+ years of clinical operations experience.
- 4+ years of clinical trial monitoring/management and vendor experience.
- Experience in Solid Tumor or Cell Therapy trials.
- Strong knowledge of ICH/GCP guidelines.
- Expertise in protocol development, clinical drug development, study design, planning, and management.
- Experience working with CROs and study vendors.
- Strong proficiency in MS Word, PowerPoint, Excel, and Project.
- Excellent interpersonal, written, and verbal communication skills.
- Excellent organizational, time management, and problem-solving skills.
- Ability to travel up to 25%.
Responsibilities
- Manage study start-up activities for multi-center, US and/or global studies.
- Perform on-site visits including feasibility, SIV, IMV, and Close-Out to assess site and CRA performance.
- Provide monitoring oversight through review of schedules, metrics, and reports.
- Oversee clinical site training and ensure adherence to protocols, GCP/ICH guidelines, and SOPs.
- Lead or participate in vendor management activities for entities such as Central Laboratories, Central Imaging, and CROs.
- Perform in-house routine data listings review and manage regulatory documentation across study lifecycle.
- Support the Clinical Trial Manager (CTM) in relationship management, contracts, logistics, and data management.
- Mentor and coach junior staff such as Clinical Trial Assistants.
- Assist in the development of protocols, informed consent, CRFs, and other study-related documentation.
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