Assistant CRA

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

📋 Description

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

• Facilitate site readiness and logistics for the monitoring process.

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

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

• Complete study-specific training and familiarize oneself with study-specific systems.

• Provide in-house assistance for pre-study evaluations and waivers.

• Tailor site informed consent forms to include site contact details as necessary.

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

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

• Review materials intended for patients and their translations.

• Assist in vendor qualification processes and manage site-system access.

• Follow up on training for site staff.

• Organize logistics for investigator meeting participation.

• Maintain vendor trackers and oversee study/site supplies management.

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

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

• Assist in the remote review of centralized monitoring tools.

• Coordinate site payment processes, system updates, reconciliations, and follow up on invoices.

• Conduct trial reconciliation activities, including CRF/query status, deviations, SAEs, and safety reports.

• Verify document collection and take action on missing, incomplete, expired, or open documents.

• Carry out other assigned site management responsibilities and client-requested FSP role profiles.

• Complete administrative duties such as expense reports and timesheets.

• Act as the primary site contact for legacy studies.

• Occasional travel to clinics or hospitals may be necessary.

⛳️ Requirements

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

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

• An equivalent combination of relevant education, training, and/or directly related experience may be acceptable.

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

• Understanding of ICH GCP, relevant regulations, and company procedural documents.

• Strong oral and written communication skills.

• Excellent interpersonal abilities and customer service aptitude.

• Good organizational and time management capabilities, with a keen attention to detail and the ability to manage multiple tasks effectively.

• Flexibility and adaptability to various situations.

• Capacity to work independently or collaboratively within a team.

• Skills in critical thinking, root cause analysis, and problem-solving.

• Proficient computer skills with a solid understanding of MS Office; capability to learn and utilize software as necessary.

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

• Strong English language proficiency and grammar skills.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.