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CRA I – Sponsor Dedicated, Oncology, Neurology
Syneos Health. Perform site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Monitoring and Site Management, ensuring compliance with ICH-GCP/GPP regulations and effective management of clinical trial processes. Proficient in data integrity verification, site performance evaluation, and communication with site personnel to achieve project objectives.
Highest-signal resume keywords
Clinical MonitoringSite ManagementICH-GCP ComplianceData Integrity VerificationExcellent Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site QualificationSite InitiationSource Document ReviewClinical Data VerificationInvestigational Product ManagementRegulatory ComplianceClinical Project Data ReviewChart AbstractionData CollectionPatient Recruitment Strategies
Soft Skills
Interpersonal SkillsPresentation SkillsProblem-Solving SkillsTeam CollaborationAdaptability
Tools & Technologies
Electronic Data CaptureClinical Monitoring SoftwareProject Management ToolsCommunication LogsTrial Master File Management
Certifications & Qualifications
Bachelor’s DegreeRegistered Nurse (RN)
Industry Keywords
Good Clinical PracticeICH GuidelinesRegulatory RequirementsReal World Late Phase StudiesSite-Level Activities
About the role
Key responsibilities & impact- Perform site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely
- Ensure regulatory, ICH-GCP/GPP and protocol compliance
- Evaluate site and staff performance and recommend site-specific actions
- Escalate serious issues and develop action plans with guidance
- Verify informed consent, subject/patient confidentiality, safety and clinical data integrity
- Assess site processes under the Clinical Monitoring/Site Management Plan
- Conduct source document review and medical-record review
- Verify clinical data in case report forms and electronic data capture compliance
- Resolve queries remotely and on site within agreed timelines
- Use hardware and software for clinical project data review and capture
- Manage investigational product inventory, reconciliation, storage, dispensing and related compliance as applicable
- Review Investigator Site Files and reconcile them with the Trial Master File
- Document monitoring activities through letters, trip reports, communication logs and project documents
- Support subject/patient recruitment, retention and awareness strategies
- Track observations, status and action items to resolution
- Manage site-level activities and communications to meet project objectives, deliverables and timelines
- Act as liaison with project site personnel and ensure site-team training and compliance
- Attend investigator, sponsor, global monitoring and clinical training meetings
- Support audit readiness, audit preparation and follow-up actions
- For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons and local country staff
Requirements
What you’ll need- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills and ability to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 30% on a regular basis
- Must comply with site requests for medical and other personal information required for facility access in the US
- For Real World Late Phase: knowledge of local requirements for real world late phase study designs
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Company car or car allowance may be included
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time