In-house Clinical Research Associate II - CNS/Neurology

Worldwide Clinical Trials•Carolina, NC

3d•$50,000 - $99,000•Remote

About The Position

Worldwide Clinical Trials is a global, midsize CRO that focuses on innovation and pioneering approaches to find cures for diseases. They are a team of over 3,500 experts dedicated to improving lives. The In-house Clinical Research Associate II (IHCRA) is responsible for site management tasks in accordance with GCPs, regulations, and SOPs. This role supports Clinical Trial Managers (CTM) and field CRAs, collaborating with project teams to meet site management deliverables. The IHCRA also provides mentorship and training to in-house team members under COM oversight.

Requirements

A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science.
A minimum of two years of clinical research experience (e.g., study coordinator, research nurse, etc.).
Experience in CNS/Neurology.
Good oral and written communication skills.
Good planning and organizational skills with effective time management.
Good interpersonal skills.
Ability to work in an organized and methodical manner.
Good understanding of clinical research principles and process.
Good understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements as required (training provided by WCT).
Good understanding of standard operating procedures (training provided by Worldwide Clinical Trials).
Basic knowledge of Microsoft Office.
Familiarity with IVRS, eCRF systems (training provided by Worldwide Clinical Trials).

Responsibilities

Assist with feasibility questionnaires and CDA collection from potential sites.
Coordinate study material shipment and receipt by study sites.
Provide applicable updates for site-related documentation for filing in the Trial Master File (TMF) and review collected/received documents for quality.
Support field CRAs with Investigator Site File (ISF) maintenance, TMF reconciliation, and TMF Quality Control Checklist (QCCL).
Conduct pre-study, study initiation, interim, and remote monitoring, and close-out visits under guidance.
Discuss and assist field CRAs and/or site staff with IP inventory.
Maintain regular communication with sites per the Clinical Monitoring Plan and Site Management and Monitoring Plan.
Complete remote review of electronic data capture systems (EDC) CRFs for completion, logic checks, and compliance.
Assist sites in the resolution of DM issued EDC queries, vendor-issued queries, etc.
Pull reports from study-specific portals, EDC systems, create or maintain study-specific trackers, and provide information to CTM.
Provide visit preparation support for field CRAs.
Assist with site staff changes as needed or requested.
Assist with vendor access management for site staff.
Support sites with prescreening, screening, and recruitment.
Assist with Subject Eligibility Review tracking and provide support to the Medical Monitor.
May serve as the main point of contact for operational aspects of the clinical research trial.
Provide mentoring and training for In-house CRA I and II.
Attend and present (if required) updates during study meetings.
Perform other duties as assigned.