Assistant CRA

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

📋 Description

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

• Assist in site readiness and provide logistical support for the monitoring process.

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

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

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

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

• Tailor Site ICFs with necessary site contact information.

• Conduct remote reviews of EMR/EHR checklists and assist with assessment data collection.

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

• Review materials intended for patients and their translations.

• Assist with vendor qualification procedures and facilitate site staff system access.

• Monitor site staff training progress.

• Manage logistics for IM attendance and maintain vendor tracking systems.

• Organize study/site supply management.

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

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

• Support ongoing remote evaluations using centralized monitoring tools.

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

• Execute reconciliation tasks including status checks on CRFs, queries, deviations, SAEs, and safety reports.

• Validate document collection status and initiate action for missing, incomplete, or expired documents.

• Perform other assigned site management responsibilities and fulfill client-requested FSP role profiles.

• Carry out administrative duties such as preparing expense reports and timesheets.

⛳️ Requirements

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

• Equivalency that combines relevant education, training, and/or directly related experience may be accepted.

• Previous experience of 0 to 2 years in a comparable role.

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

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

• Strong oral and written communication skills.

• Excellent interpersonal abilities and customer service skills.

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

• Proven capacity to manage multiple tasks efficiently and effectively.

• Flexibility and adaptability to changing circumstances.

• Ability to work collaboratively in a team or independently as required.

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

• Competent computer skills with a solid understanding of MS Office; ability to learn and utilize relevant software.

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

• Excellent proficiency in the English language and grammar.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Office Hours (40 hours per week).

• Opportunity for advancement to CRA within 1 to 2 years.