Assistant CRA – FSP

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Execute remote tasks on designated projects in collaboration with the CRA and Clinical Lead of the study.

• Facilitate site readiness and the monitoring process.

• Assist in site management and remote monitoring duties in alignment with SOPs and regulatory requirements.

• Carry out study and site management tasks as outlined in the task matrix.

• Complete and document training specific to the study and familiarize with study-specific systems.

• Provide internal support during pre-study evaluations and assessment waivers.

• Tailor site ICFs with the relevant site contact details as necessary.

• Conduct remote reviews of EMR/EHR checklists and assist with relevant assessments.

• Confirm document collection and RCR submission status; update site EDL and site information accordingly.

• Review materials intended for patients and their translations.

• Assist in vendor-related qualification processes for site personnel.

• Aid in managing system access requests, approvals, and revocations for site personnel.

• Follow up on training for site staff.

• Organize logistics for IM attendance.

• Maintain vendor tracking systems.

• Oversee study/site supply management.

• Support the collection, review, and updating of essential documents within the system.

• Follow up on outstanding vendor data, including ECGs, lab samples, and e-diaries.

• Assist with the ongoing remote evaluation of centralized monitoring tools.

• Help facilitate site payment processes, system updates, reconciliations, and invoice follow-ups.

• Carry out reconciliation tasks related to CRF and query status, deviations, SAEs, and safety reports.

• Verify document collection status and initiate actions on missing, incomplete, or outdated documents.

• Perform other designated site management responsibilities as instructed by the CRA and outlined in the task matrix.

• Complete administrative duties, such as expense reports and timesheets.

• Occasional travel to clinics or hospitals may be necessary.

⛳️ Requirements

• Bachelor's degree in a life science discipline or a related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualifications.

• Prior experience providing the necessary knowledge, skills, and abilities to perform the job, typically ranging from 0 to 2 years.

• Equivalency through a combination of relevant education, training, and/or directly related experience may be accepted.

• Previous experience in oncology clinical trial management is highly regarded.

• Basic understanding of medical/therapeutic areas and familiarity with medical terminology.

• Capability to acquire and maintain a thorough understanding of ICH GCP, relevant regulations, and company procedural documents.

• Strong oral and written communication skills.

• Excellent interpersonal abilities and customer service skills.

• Good organizational, time management skills, and keen attention to detail.

• Capacity to manage multiple tasks efficiently and effectively.

• Adaptability and flexibility.

• Ability to work independently or collaboratively within a team.

• Well-developed critical thinking, root cause analysis, and problem-solving capabilities.

• Proficient in computer skills and a solid understanding of MS Office.

• Ability to learn and utilize relevant software and modern technology.

• Capability to extract essential information from study documents, electronic study data systems, CTMS, and dashboards.

• Excellent proficiency in English language and grammar.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.