Assistant CRA

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

📋 Description

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

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

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

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

• Complete and document training specific to the study and familiarize yourself with study-specific systems.

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

• Tailor Site ICF with relevant site contact information as necessary.

• Conduct remote reviews of EMR/EHR checklists.

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

• Review materials intended for patients and their translations.

• Assist in vendor qualification processes and facilitate site staff access to systems.

• Follow up on training for site personnel.

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

• Manage logistics related to study/site supplies.

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

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

• Support remote evaluations of centralized monitoring tools.

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

• Carry out reconciliation tasks for CRFs, queries, deviations, SAEs, and safety reports.

• Verify the status of document collection and drive actions on any missing or incomplete documentation.

• Carry out other designated site management tasks and FSP role profiles as instructed.

• Complete administrative duties such as expense reports and timesheets.

⛳️ Requirements

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

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

• An equivalency of appropriate education, training, and/or directly related experience may be deemed adequate.

• Fundamental knowledge of medical/therapeutic areas and understanding of medical terminology.

• Working familiarity with ICH GCP, relevant regulations, and company procedural documents.

• Strong oral and written communication abilities.

• Excellent interpersonal and customer service skills.

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

• Demonstrated capability to manage multiple tasks efficiently and effectively.

• Flexibility and adaptability are essential.

• Ability to work both collaboratively in a team setting and independently.

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

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

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

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

• Exceptional English language and grammar proficiency.

🏝️ Benefits

• Fully remote work setup.

• Standard work hours from Monday to Friday.

• Option for an office or home office environment.

• Some travel to clinics or hospitals may be necessary.