In-house Clinical Research Associate II - CNS/Oncology

Worldwide Clinical Trials•Carolina, NC

About The Position

The experienced In-house Clinical Research Associate II (IHCRA) is responsible for site management tasks for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). The In-House Clinical Research Associate II provides support to Clinical Trial Managers (CTM) and field Clinical Research Associates (CRA) and collaborates with project team members across a variety of roles and departments to ensure timely achievement of site management deliverables per contracted timelines. The role provides mentorship and training of in-house team members with COM oversight.

Requirements

A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science AND A minimum of two years of clinical research experience (e.g., study coordinator, research nurse, etc.)
Candidates must have experience in both Oncology and 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, and training provided by Worldwide Clinical Trials

Nice To Haves

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Responsibilities

Assist with feasibility questionnaires and CDA collection from potential sites, as requested
Coordinate study material (e.g., CRFs, manuals) shipment and receipt by study site
Provide applicable updates for site-related documentation for filing in the Trial Master File (TMF) and review collected/received documents for quality in accordance with GDP and WCT SOPs prior to submission to the TMF.
Support field CRA with maintenance of the Investigator Site File (ISF) by assisting with Trial Master File (TMF) reconciliation and providing support on TMF Quality Control Checklist (QCCL)
Conduct pre-study, study initiation, interim and remote monitoring, and close-out visits under the guidance of the field CRA or CTM/PM, as applicable and appropriate
Discuss and assist field CRA and/or site staff with IP inventory, as applicable and appropriate
Maintain regular communication with sites per the Clinical Monitoring Plan and Site Management and Monitoring Plan, as needed and applicable for the assigned study
Complete remote review of electronic data capture systems (EDC) CRFs for completion, logic checks, and compliance with data entry requirements/guidelines.
Assist sites in the resolution of DM issued EDC queries, vendor-issued queries, etc.
Pull reports from study-specific portals, EDC systems, etc., create or maintain study-specific trackers, and provide information to CTM for distribution to or use by the project team/sponsor.
Provide visit preparation support for field CRAs, including but not limited to routine summation/communication of (e.g., Action Items, Protocol Deviations, EDC queries, vendor queries, study supplies, and/or pending site staff training prior to scheduled onsite visits, etc.)
Assist with site staff changes as needed or as requested (e.g., CTMS updates, essential document collection, regulatory document collection, and review of site staff training, qualifications, and task delegation)
Assist with vendor access management for site staff (request/revoke access)
Support sites with prescreening, screening, and recruitment
Assist with Subject Eligibility Review tracking and provide support to the Medical Monitor, as applicable and budgeted
May serve as the main point of contact for operational aspects of the clinical research trial, as applicable and appropriate
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.