Assistant CRA

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

📋 Description

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

• Facilitate site readiness and assist in the monitoring process.

• Aid with site management and remote monitoring activities in line with SOPs and regulatory standards.

• Engage in limited site contact tasks during study initiation, management, recruitment, and closure phases.

• Execute and document study and site management responsibilities as outlined in the task matrix.

• Complete and record study-specific training while familiarizing with study-specific systems.

• Provide internal support for pre-study evaluations and waivers.

• Tailor Site ICFs with necessary site contact information.

• Conduct remote reviews of EMR/EHR checklists and support assessments.

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

• Evaluate patient-facing materials and translations.

• Assist with vendor qualification, system access, training for site staff, IM attendance, vendor trackers, and study/site supplies.

• Aid in the collection, review, and updating of Essential Documents within systems.

• Follow up on missing vendor data such as ECGs, lab samples, and e-diaries.

• Contribute to ongoing remote evaluations of centralized monitoring tools.

• Assist with site payment procedures, system updates, reconciliations, and invoice follow-ups.

• Conduct reconciliation activities for CRFs, queries, deviations, SAEs, and safety reports.

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

• Execute other assigned site management duties and client-requested FSP role profiles.

• Complete administrative responsibilities such as expense reports and timesheets.

⛳️ Requirements

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

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

• A combination of appropriate education, training, and/or directly related experience may also be considered.

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

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

• Strong oral and written communication skills.

• Exceptional interpersonal and customer service abilities.

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

• Capability to manage multiple tasks efficiently and effectively.

• Flexibility and adaptability in various situations.

• Ability to work independently as well as collaboratively in a team.

• Strong critical thinking, root cause analysis, and problem-solving skills.

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

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

• Competence in extracting relevant information from study documents, electronic study data systems, CTMS, and dashboards.

• Excellent command of the English language and grammar.

🏝️ Benefits

• Fully remote work environment.

• Standard work schedule from Monday to Friday.

• Home office setup.

• Occasional travel to clinics/hospitals may be necessary.

• Opportunity to engage in projects supporting leading pharmaceutical companies and biotechs.

• Potential for career-track promotional opportunities.