Clinical Research Associate
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇹🇷 Turkey
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- The CRA executes clinical monitoring activities at clinical trial sites
- Monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs
- Performs monitoring activities related to selection, initiation, conduct, and timely completion of oncology/hematology clinical trials
- Collaborates closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and quality standards are maintained
- Identifies gaps and areas for improvement and proposes CAPA
- Supports start-up and provides local expertise
- Conducts feasibility, site identification, selection, and evaluation
- Provides protocol and related study training to assigned sites
- Conducts monitoring visits per monitoring plan and applicable SOPs
- Completes monitoring visit reports
- Manages sites and site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
- Establishes lines of communication with sites
- Attends disease indication project specific training and general CRA training as required
- Facilitates Study Oversight Visits (SOVs), site audits and/or inspections as required
- Evaluates the quality and integrity of site practices
- Strives for operating excellence, questions status-quo and promotes innovation
Requirements
- BS in a relevant scientific discipline
- Minimum of 2 years of monitoring experience
- At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English & Turkish (writing and speaking)
- Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical monitoringoncology trialshematology trialsGCPICH guidelinesCAPAsite evaluationregulatory submissionsdata query resolutionmonitoring visit reports
Soft skills
communication skillsinterpersonal skillsorganizational skillsprioritizationmulti-taskingcollaborationproblem-solvinginnovationattention to detailoperating excellence