Assistant CRA

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

📋 Description

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

• Aid in site readiness and the monitoring procedures.

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

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

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

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

• Tailor site informed consent forms with the necessary site contact information.

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

• Confirm the status of document collection and RCR submissions; update the site EDL and verify site information.

• Review materials intended for patients and their translations.

• Assist in the site staff qualification processes related to vendors.

• Coordinate system access for pertinent site personnel.

• Follow up on training for site staff.

• Organize logistics for attendance at investigator meetings.

• Maintain vendor trackers and manage study/site supplies.

• Support the collection, review, and updating of essential documents in systems.

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

• Facilitate remote reviews of centralized monitoring tools.

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

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

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

• Perform administrative duties, including managing expense reports and timesheets.

⛳️ Requirements

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

• Relevant experience providing the necessary knowledge, skills, and abilities for the role, typically ranging from 0–2 years.

• A combination of adequate education, training, and/or directly related experience may be considered as an equivalent.

• Fundamental understanding of medical and therapeutic areas.

• Familiarity with medical terminology.

• Capability to acquire and sustain working knowledge of ICH GCP, relevant regulations, and organizational procedural documents.

• Strong oral and written communication skills.

• Exceptional interpersonal and customer service abilities.

• Effective organizational and time management skills.

• Keen attention to detail and the ability to manage multiple tasks efficiently.

• Flexibility and adaptability to changing situations.

• Proficiency in working independently as well as part of a team.

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

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

• Ability to learn and utilize relevant software effectively.

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

• Excellent command of the English language and grammar.

🏝️ Benefits

• Fully remote work.

• Standard Monday–Friday work schedule.

• Home office environment.

• Reasonable accommodations for individuals with disabilities.

• Equal opportunity employment.