Site Care Partner
ICON plc
Google Cloud Platform
Senior Clinical Research Associate, Oncology
Parexel
full-time
Posted on:
Location Type: Hybrid
Location: Harrow • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Oversight of monitoring responsibilities and study conduct ensuring regulatory, ICH-GCP and protocol compliance
- Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations and action plans
- Verify informed consent, protect subject confidentiality, and assess factors affecting subject safety and data integrity
- Conduct monitoring activities remotely and on-site, including source document review and verification of site medical records
- Verify clinical data entered in Case Report Forms (CRF) is accurate and complete; manage query resolution
- Manage reporting of protocol deviations, adverse event monitoring follow-up, and appropriate documentation
- Perform investigational product (IP) inventory, reconciliation and review storage and security as applicable
- Document activities via follow up letters, monitoring reports, communication logs, and enter data into tracking systems
- Ensure site personnel are appropriately delegated and trained; review and confirm delegation logs and signature sheets
- Review data entry timeliness, missing pages, outstanding queries, and support inspection readiness
- Collaborate with Site Manager, prepare for and attend Investigator and sponsor meetings, and participate in global project meetings
Requirements
- Recent oncology experience required
- Networking and relationship building skills
- Ability to communicate effectively and appropriately with internal and external stakeholders
- Ability to adapt to changing technologies and processes
- Effectively overcoming barriers encountered during the implementation of new processes and systems
- Excellent communication (verbal and written), presentation, and interpersonal skills
- Identifies and builds effective relationships with investigator site staff and other stakeholders
- Proficiency in local language is required
- Advanced level or fluency in English is required
- Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
- Working knowledge of ICH-GCP Guidelines, relevant regulations, and company Standard Operating Procedures (SOPs)/processes
- Experience with source document review, CRF/data verification, query resolution, and IP accountability
- Ability to conduct remote and on-site monitoring per the Clinical Monitoring Plan (CMP) or Study Monitoring Plan (SMP)
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
source document reviewCRF data verificationquery resolutionIP accountabilitymonitoring activitiesregulatory complianceprotocol complianceadverse event monitoringdata integrityinvestigational product inventory
Soft skills
networkingrelationship buildingeffective communicationadaptabilityproblem-solvinginterpersonal skillspresentation skillsstakeholder engagementteam collaborationtraining and delegation
Certifications
Bachelor's degreeRegistered Nurse (RN)
