CovarsaDx · 18 hours ago
Clinical Trials Associate
United States
Full-time
Onsite
Entry Level
$60K/yr - $75K/yr
2+ years expCovarsaDx is a company focused on clinical operations, and they are seeking a Clinical Trials Associate to support clinical trial operations. The role involves assisting with monitoring and supporting Clinical Research Associates with studies, requiring strong organizational skills and attention to detail.
BiotechnologyClinical TrialsConsultingHealth CareMedical DevicePharmaceuticalQuality Assurance
Responsibilities
Support lead study CRA in the management and execution of studies
Work with lead study CRA to perform remote site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. These tasks include:
Perform study monitoring to include site regulatory documents, consent forms and source data verification of data included on case report forms
Assist with document collection for trial master files
Order, track and manage investigational product at sites
Write site contact reports and monitoring reports for study communication and visits
Ensure compliance with SOPs and regulations including FDA, ICH and GCP guidelines
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
Collaborate and liaise with study team members for project execution support as appropriate
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements
Travel on a limited basis and at short notice to sites for monitoring visits
Provide clinical administrative support and other projects operating under CovarsaDx Canada and ZoaDx as directed
Qualification
Required
Bachelor's degree with relevant clinical research experience
Two (2) years of experience in clinical research or clinical trial management
Strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment
Ability to communicate effectively (written and verbal) with study teams, participants, and external stakeholders
Excellent attention to detail and the ability to keep detailed, accurate records and ensure all protocol requirements and regulations are strictly followed
Able to work with various groups to support documentation needs and ensure alignment across teams
Strong time management skills, able to use time productively to ensure high levels of operational efficiency and effectiveness
Able to maintain strict confidentiality in handling sensitive participant data and study-related information
Competence using common business software such as MSOffice (Word, Excel, PowerPoint, Outlook, Teams) and Adobe Acrobat and study-specific tools or software
Knowledge of laboratory procedures and equipment
Must possess analytical and creative thinking skills
Preferred
Two (2) years of experience in clinical research or clinical trial management is preferred
Benefits
Medical, Dental, Vision insurance
Life/Short- and Long-Term Disability
401K Plan and company match
PTO, Sick and Holiday Pay
Company
CovarsaDx
CovarsaDx provides clinical research, regulatory consulting, and trial management for in vitro diagnostics and medical devices.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Chermaen Wong-Lindberg
President and CEO, CovarsaDx
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