[Hiring] In-House Clinical Research Associate II @Worldwide Clinical Trials

Role Description

Responsible for site management tasks for clinical 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.

• 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 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.

Qualifications

• 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.
• Basic understanding of clinical research principles and process.
• Basic understanding of FDA and/or EU Directives and regulations, ICH Guidelines and local regulatory requirements, training provided by WCT.
• 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.

Requirements

• A minimum 2-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science preferred.
• Two-year college curriculum or equivalent education/training and one year of experience with clinical research (e.g., study coordinator, CTA, etc.) or other experience deemed relevant.
• Other relevant education/training and a minimum of two years of clinical research experience may be considered (example: LPN certification and/or relevant work experience).
• Fluent in the local languages of the countries under responsibility and proficient in both spoken and written English.
• 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.

Benefits

• Equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.