In-house Clinical Research Associate II

In-House Clinical Research Associate

Experienced In-house CRA 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). Provide support to Clinical Trial Managers (CTM) and field Clinical Research Associates (CRA) and collaborate with project team members across a variety of roles and departments to ensure timely achievement of site management deliverables per contracted timelines.

Provide mentorship and training of in-house team members with COM oversight.

What You Will Do:

• 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
• IHCRAs are not responsible for onsite review of IP receipt, accountability, return nor destruction except as part of the conduct of an onsite monitoring visit as described above.
• Maintain regular communication with sites per the Clinical Monitoring Plan and Site Management and Monitoring Plan, as needed and applicable for 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 resolution of DM issued EDC queries, vendor issued queries, etc.
• Pull reports from study-specific portals, EDC systems, etc., creates or maintains study-specific trackers, and provide information to CTM for distribution to or use by 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 provides support to Medical Monitor, as applicable and budgeted
• May serve as main point of contact for operational aspects for 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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

What You Will Bring To

The Role:

• 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 WCT
• Basic knowledge of Microsoft Office
• Familiarity of IVRS, eCRF systems, training provided by WCT

Your

Experience:

• 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.) OR one year of IHCRA experience OR other experience deemed relevant
• Two-year college curriculum or equivalent education/training ANDA minimum of three years of clinical research experience (e.g., study coordinator, research nurse, etc.) OR two years of IHCRA experience OR other experience deemed relevant
• Other relevant education/training (example: LPN certification and/or relevant work experience) and a minimum of four years of clinical research experience may be considered or two years of IHCRA experience
• Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The…