Assistant CRA – FSO

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

📋 Description

• Execute remote tasks related to assigned projects in collaboration with the CRA and Clinical Lead of the study.

• Aid in site readiness and facilitate the clinical trial monitoring process.

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

• Conduct limited site contact activities during study initiation, site management, recruitment, and closing phases.

• Fulfill study and site management responsibilities outlined in the task matrix.

• Complete and document study-specific training and provide orientation on study-specific systems.

• Offer in-house support during pre-study evaluations and assessment waivers.

• Tailor site informed consent documents with necessary site contact information.

• Conduct remote reviews of EMR/EHR checklists.

• Confirm document collection, RCR submission status, and site-related information.

• Review materials intended for patients and their translations.

• Assist with vendor qualification, system access, site staff training, and the maintenance of vendor trackers.

• Organize logistics for IM attendance and manage study/site supply distribution.

• Support the collection, review, and updates of essential documents in the system.

• Follow up on missing vendor information, which includes ECGs, lab samples, and e-diaries.

• Facilitate ongoing remote reviews of centralized monitoring tools.

• Aid in site payment processes, system updates, reconciliations, and follow-up on invoices.

• Conduct trial reconciliation tasks related to CRF and query status, deviations, SAEs, and safety reports.

• Verify the status of document collection and initiate action for any missing, incomplete, or expired documents.

• Perform additional assigned site management tasks and fulfill client-requested FSP role profiles.

• Complete administrative duties, including expense reports and timesheet submissions.

⛳️ Requirements

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

• Prior experience ranging from 0 to 2 years is preferred.

• A combination of relevant education, training, and/or directly related experience may be taken into account.

• Fundamental knowledge of medical/therapeutic areas and familiarity with medical terminology.

• Working understanding of ICH GCP, relevant regulations, and company procedural documents, or the ability to acquire and maintain such knowledge.

• Strong oral and written communication skills.

• Excellent interpersonal abilities and customer service skills.

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

• Demonstrated capacity to efficiently manage multiple tasks.

• Adaptability and flexibility in the work environment.

• Capability to work collaboratively in a team or independently.

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

• Proficient in computer skills with a good understanding of MS Office applications.

• Willingness to learn and utilize relevant software.

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

• Excellent command of the English language and grammar.

🏝️ Benefits

• Fully remote working arrangement.

• Occasional travel to clinics/hospitals may be necessary.

• Opportunity to collaborate with a global team.

• Potential for promotional opportunities on the CRA career track.