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Senior Clinical Research Associate
CTI Clinical Trial and Consulting Services. Serve as the main CTI contact for assigned study sites .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial monitoring, including site management, regulatory compliance, and effective communication with stakeholders. Proficient in managing essential documents and supporting regulatory submissions while ensuring adherence to ICH GCP standards.
Highest-signal resume keywords
Clinical Trial Monitoring ExperienceRegulatory ComplianceSite Management ActivitiesClinical Research ExperienceContract Negotiation Support
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 InitiationSource Document VerificationCRF RetrievalRegulatory Document ManagementInvestigational Product AccountabilityStudy-Specific TrainingClinical Trial SystemsPatient Information CustomizationMonitoring Plan ExecutionData Cleaning Support
Soft Skills
Effective CommunicationProblem-SolvingTeam CollaborationAttention to DetailTime Management
Tools & Technologies
Clinical Trial Management SystemsTrial Master File ManagementInvestigator Site File Management
Certifications & Qualifications
Bachelor's Degree in Allied Health FieldRegistered Nurse (RN) License
Industry Keywords
Clinical Research Associate (CRA)Good Clinical Practice (GCP)Standard Operating Procedures (SOPs)Investigational Product (IP)Clinical Research Organization (CRO)
About the role
Key responsibilities & impact- Serve as the main CTI contact for assigned study sites
- Conduct pre-study, site initiation, interim monitoring, and close-out visits
- Complete site visit deliverables accurately and within Monitoring Plan timelines
- Assist with study start-up, feasibility, pre-study activities, and site selection
- Collect, review, and track essential and regulatory documents
- Participate in investigator, client, and project team meetings
- Create and implement subject enrollment strategies
- Ensure proper storage, dispensation, and accountability of Investigational Product and trial-related materials
- Perform site management activities and provide site status updates to the Clinical Project Manager
- Conduct remote monitoring according to study-specific Monitoring Plans
- Track subject status, CRF retrieval, source document verification, regulatory documents, and Investigational Product using systems and reports
- Support project-specific activities and development of CRFs and study documents
- Support translation, customization, and review of patient information, informed consent, protocol synopsis, and other study documents
- Support regulatory submission documentation and follow up through approval where applicable
- Provide regular updates to the Sponsor/Client
- Assist with and attend investigator and client meetings
- Liaise with Clinical Data Management on data cleaning
- Identify site issues, implement corrective actions, or escalate issues
- Manage the Investigator Site File and Trial Master File for assigned sites
- Support contract negotiation, investigator payments, and site payment tracking where applicable
Requirements
What you’ll need- At least 1 year of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
- Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health / natural science; or RN with an Associate's Degree; or 3-year Nursing Diploma with at least 2 years clinical nursing experience; or equivalent experience as determined by CTI Management and Human Resources
- Previous experience conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO
- Demonstrated successful performance in a CRA position
- Minimum of 1 year of on-site monitoring experience preferred
- Adherence to applicable regulatory requirements, SOPs, and ICH GCP
- Ability to complete general and study-specific training
- Experience with clinical trial systems and reports, CRFs, SDV, regulatory documents, IP, ISF, and TMF
- Ability to support regulatory submissions and contract negotiation where applicable
Benefits
Comp & perks- Structured mentoring program
- Leadership courses
- Tuition reimbursement
- Dedicated training department
- Generous health benefits
- Vacation packages
- Hybrid work from home opportunities
- Paid parental leave
- CTI Cares program
- Work-life balance support