Remote Clinical Research Associate

Advanced Clinical; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Advanced Clinical is seeking a Senior Clinical Research Associate for a remote contract with very minimal travel (<10%). The role focuses on Oncology Diagnostics studies, including site start-up, SQVs, SIVs, and remote site monitoring.

Responsibilities include eTMF management, CTMS updates, EDC query follow-up, and data cleaning, with ongoing site support and communication with sites.

Qualifications

• 4 years of regional/site monitoring experience.
• Experience on oncology trials.
• Study Start-Up and SIV experience required.
• Ability to communicate with sites and provide updates and support.

Responsibilities

• Provide high level logistical support for study start up, monitoring, and close-out.
• Develop study-related documents with minimal guidance.
• Manage contracting, budgeting, invoicing, and payments for vendors and sites.
• Support data management with EDC design and testing.
• Handle filing, archiving, and SOP-compliant documentation.
• Oversee biospecimen logistics and tracking.
• Train CROs, vendors, and site staff on study requirements.
• Develop monitoring plans and identify protocol deviations or data issues.
• Coordinate participant consent, ethics submissions, and study tracking.

Skills

Site monitoring

Oncology trials

Study Start-Up

SIV visits

Remote monitoring

Tools

Google Workspace

Job description

We are seeking a Senior CRA (Remote Contract with VERY MINIMAL TRAVEL – Less than 10%) for a successful and stable Molecular Diagnostics Sponsor.

This Senior CRA to support Oncology Diagnostics studies.

You will perform site start-up activities and visits (such as SQVs and SIVs), Site Monitoring Visits/IMVs (mostly remote visits), and related pre- and post-monitoring activities.

This Senior CRA should be able to communicate with sites, deliver presentations, provide updates, and provide ongoing site management and support.

Also: Support eTMF management, document filing, CTMS updates, EDC query follow-up, and site data cleaning activities.

Requirements

• 4 years of Regional/Site Monitoring experience.
• Experience working on oncology trials
• Tech Savvy, ability to pick up new systems quickly, experience working in google workplace a plus.
• Recent Study Start-Up, SIV visit experience a hard requirement

Primary Responsibilities

• Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations
• Develop study-related documents with minimal Clinical Trial Manager guidance including protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
• Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight
• Support the Clinical Data Management team in the design and content of case report forms, completion guidelines, including support and testing of an EDC
• Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements
• Oversees clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information
• Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
• Develop new study monitoring plans, and monitor studies following study monitoring plans to identify protocol deviations or data discrepancies
• Perform study activities including consent participants for research studies, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies