Nextrials, Inc. · 9 hours ago
Site & Study Start Up Specialist
Blue Bell, PA
Full-time
Onsite
Entry, Mid Level
2+ years expNextrials, Inc. is a leading healthcare intelligence and clinical research organization. They are currently seeking a Study Start Up Associate II to lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to innovative treatments and therapies.
Health CareMedicalSoftware
Responsibilities
Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency
Qualification
Required
Bachelor's degree in life sciences or a related field
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Benefits
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Company
Nextrials, Inc.
Founded by bio-pharmaceutical researchers in 1999, Nextrials offers today’s most advanced e-clinical tools and services for speeding the delivery of lifesaving drugs and medical devices to market.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2016-03-18Acquired
Leadership Team
J
Jim Rogers
Founder, President and CEO
L
Lecia Shaffer
Clinical Operations
Company data provided by crunchbase