Assistant CRA FSP

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

📋 Description

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

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

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

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

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

• Assist with pre-study evaluations and the waiving of pre-study assessments.

• Tailor Site ICFs with necessary site contact information as required.

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

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

• Review materials intended for patients and their translations.

• Support vendor qualification processes for site personnel.

• Manage system access for relevant site staff during pre-activation and study execution phases.

• Follow up on training for site staff.

• Organize logistics for IM attendance and maintain vendor tracking records.

• Oversee study/site supply management.

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

• Pursue missing vendor data, including ECGs, lab samples, and e-diaries.

• Contribute to ongoing remote evaluations using centralized monitoring tools.

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

• Conduct reconciliation tasks that involve CRF/query status, deviations, SAEs, and safety reports.

• Confirm the status of document collection and take action on missing, incomplete, or expired documents and open findings.

• Perform other site management duties as assigned by the CRA and task matrix.

• Timely completion of administrative tasks, including expense reports and timesheets.

⛳️ 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 to 2 years is preferred.

• Equivalency may be considered through a mix of suitable education, training, and/or directly related experience.

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

• Capability to achieve and maintain a thorough understanding of ICH GCP, relevant regulations, and company procedural documents.

• Strong oral and written communication skills.

• Excellent interpersonal abilities and customer service skills.

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

• Demonstrated ability to manage multiple tasks efficiently and effectively.

• Flexibility and adaptability in work approach.

• Ability to collaborate in a team or work independently.

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

• Proficient computer skills and solid knowledge of MS Office applications.

• Capability to learn and utilize appropriate software and modern technology effectively.

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

• Excellent command of English and Turkish language and grammar.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday to Friday work schedule.

• Option for an office or home office environment.

• Occasional travel to clinics or hospitals may be necessary.

• Opportunity to collaborate with a global team supporting clinical trials in pharmaceuticals and biotechnology.

• Potential career advancement opportunities in CRA roles.