Job Description

JOB DESCRIPTION:

The in-house Clinical Research Associate will report to the Senior Clinical Project Manager and will be responsible for supporting clinical team initiatives, including activities associated with clinical trial startup and maintenance.

Volastra is a fast-paced biotech company of passionate employees, and there is ample opportunity for the ideal candidate to grow and develop with the organization. Individuals will from time to time have the opportunity to gain experience with projects outside their direct scope of work.

Job is based in NYC with a flexible option for hybrid work

RESPONSIBILITIES:

• Support all operational aspects of assigned clinical trial(s), including study start-up, enrollment, study conduct, and close-out
• Track metrics related to clinical trial milestones including, but not limited to investigational product release, site activation, site visit dates, subject visit milestones, etc.
• Review reports and maintain trackers related to investigational product accountability, study materials, subject sample management, etc.
• Assist with review and QC of essential clinical documents, including but not limited to study documents, training slides and subject-facing materials
• Coordinate distribution of study-specific communications to CROs, vendors and clinical sites
• Assist in planning and organizing external project-specific meetings including but not limited to vendor meetings, external CRA training, Investigator Meeting and PI meetings
• Assist in generating and distributing agendas and minutes for study team meetings
• Proactively identify and escalate issues to the Senior Clinical Project Manager
• Organize essential documents for the Trial Master File

REQUIREMENTS

• Bachelor’s degree in a relevant field
• At least 2 years of relevant clinical research experience
• Experience in oncology preferred
• Experience working with CTMS, EDC and eTMF systems
• Knowledge of applicable ICH/GCP/FDA guidelines/regulations
• Highly detail oriented and organized
• Ability to multitask and handle multiple responsibilities simultaneously
• Demonstrated strong work ethic and curiosity to learn and contribute
• Strong interpersonal skills, including verbal and written communication, are essential
• Ability to work in a collegial and collaborative manner
• Ability to work in a fast-paced and informal startup environment

SALARY RANGE:

$70,000 – $110,000, which may vary depending on qualifications, experience and ultimate leveling.

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