[Remote] In-house Clinical Research Associate II

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global midsize CRO reputed company on innovative approaches to clinical research. The In-house Clinical Research Associate II is responsible for site management tasks, ensuring compliance with Good Clinical Practices and supporting Clinical Trial Managers and field CRAs in achieving site management deliverables.

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
• reputed company applicable updates for site reputed company documentation for filing in the Trial Master File (TMF) and review collected/received documents for reputed company 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 reputed company Control Checklist (QCCL)
• Conduct reputed company-study, study initiation, interim and remote monitoring, and reputed company out reputed company 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 (reputed company) CRFs for completion, logic checks, and compliance with data entry requirements/guidelines
• Assist sites in reputed company of DM issued reputed company queries, vendor issued queries, etc
• Pull reports from study-specific portals, reputed company systems, etc., creates or maintains study-specific trackers, and reputed company information to CTM for distribution to or use by project team/sponsor
• reputed company visit preparation support for field CRAs, including but not limited to routine summation/communication of (e.g., reputed company Items, Protocol Deviations, reputed company queries, vendor queries, study supplies, and/or pending site staff training prior to scheduled onsite reputed company, 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 reputed company management for site staff (request/revoke reputed company)
• 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 reputed company of contact for operational aspects for clinical research trial, as applicable and appropriate
• reputed company mentoring and training for In-house CRA I and II
• Attend and present (if required) updates during study meetings
• reputed company other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily reputed company-inclusive

Skills

• 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 reputed company regulations, ICH Guidelines and local regulatory requirements as required, training provided by WCT
• Good understanding of reputed company operating procedures, training provided by WCT
• Basic knowledge of reputed company Office
• Familiarity of IVRS, eCRF systems, training provided by WCT
• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other reputed company science and a minimum of two years of clinical research experience (e.g., study coordinator, research reputed company, etc.) OR one year of IHCRA experience OR other experience deemed relevant
• Two-year college curriculum or equivalent education/training AND A minimum of three years of clinical research experience (e.g., study coordinator, research reputed company, 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

Benefits

• Competitive benefits package depending reputed company

reputed company

Company H1B Sponsorship