Clinical Research Associate II Job in Sofia 1217
job ID: 8599
Position Title: Clinical Research Associate II
Working Location: Bulgaria, Sofia
Employment Status: Full-Time Regular
Required Experience: Not Applicable
Required Education: Not Indicated
Required Travel: 0
Job Summary:
POSITION SUMMARY:
Responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures. May serve in Lead CRA role.
Core Responsibilities:
ESSENTIAL JOB FUNCTIONS:
1. Communication
• Maintains timely and effective communication among team members and site staff.
• Keeps project leadership apprised of team issues, seeking guidance as needed.
• Participates in Business Development client presentations and bid defenses as requested.
2. Regulatory Documentation
• Assures compliance with CFR, State regulations, ICH and GCP guidelines and INC Research and sponsor SOPs.
• Maintains current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.
• Participates in TMF and on-site audits as requested.
3. Monitoring
• Assumes responsibility for site management and site staff performance including:
• Monitors all types of clinical trials.
• Participates in all types of site visits.
• Assures Principal Investigator (PI) integrity.
• Assures compliance with all protocol requirements.
• Assures effective patient identification and recruitment plan is in place.
• Assures timely reporting of AEs/ SAEs and Protocol Violations.
• Regularly performs Investigational Product (IP) accountability.
• Regularly reviews the status of contents of the site Regulatory Binder.
• Resolves problematic issues in a productive way.
• Exhibits effective time management skills.
• Performs observation visits with less experienced CRAs.
4. Data Handling
• Performs source document verification (SDV) according to contractual requirements.
• Assures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).
• Assures timely and accurate completion of Data Clarification Forms (DCFs).
• Performs clinical data listings reviews as needed.
5. Reporting and Tracking
• Completes and submits visit reports according to SOP/WI or sponsor requirements and requiring minimal revisions.
• Maintains awareness of key study performance indicators for own sites, e.g. TCRs, patient enrollment, SAEs.
• Updates study and patient status information and serves as (CTMS) resource for PM/LCRA.
• Tracks Investigator payments/ milestones, if requested.
• Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
6. Administrative
• Prepares for and attends investigator’s meetings as requested. May present as requested.
• Assists with the preparation of study start up materials and tools, as requested.
• Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project Communication, Monitoring and / or Training Plans.
• May assume Lead CRA role and/ or assist with LCRA activities, e.g., tool development, study plans, team training.
OTHER RESPONSIBILITIES:
Performs other work related duties as assigned. Demonstrates basic understanding of SOPs, WI, FDA and local regulations as well as ICH guidelines. Extensive travel may be required (more than 50%).
Skills Attributes:
EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:
Requires a BA/BS degree in the science/health care field or nursing degree or equivalent combined education and experience plus nominal clinical or related research experience some independent field monitoring experience. Requires strong organizational, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required. Must have valid, current driver’s license and ability to secure corporate credit card.
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