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Senior Clinical Research Associate
Innovaderm Research Inc.. Monitor the progress of clinical studies at investigative sites or remotely .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical monitoring, ensuring compliance with ICH-GCP standards and regulatory requirements while effectively managing site relationships and data integrity. Proficient in conducting site visits and preparing detailed reports to support clinical trial objectives.
Highest-signal resume keywords
Clinical Monitoring ExperienceICH/GCP KnowledgeSite Visit ReportingRegulatory ComplianceStrong 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
Clinical Trial MonitoringSource Data VerificationRegulatory Document CollectionPatient Recruitment StrategiesSite Qualification and InitiationAttention to DetailProblem-Solving SkillsData CollectionStudy Drug AccountabilityExperience in Dermatology
Soft Skills
Verbal CommunicationWritten CommunicationJudgementAbility to PrioritizeWork Under Pressure
Tools & Technologies
Microsoft OfficeWordExcelPowerPoint
Industry Keywords
BiotechnologyPharmaceuticalContract Research OrganizationClinical ResearchInvestigators' Meetings
About the role
Key responsibilities & impact- Monitor the progress of clinical studies at investigative sites or remotely
- Ensure clinical trials are conducted, recorded, and reported according to the protocol, SOPs, ICH-GCP, and applicable regulatory requirements
- Conduct site qualification, initiation, monitoring, and close-out visits according to monitoring plans, sponsor and company SOPs, ICH/CGP guidelines, and applicable regulations
- Participate in investigators’ meetings
- Prepare site visit reports and follow-up letters to investigators
- Build productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets
- Perform source data verification
- Ensure adequate on-site study drug storage, dispensing, and accountability
- Ensure data collection and regulatory document collection are adequate
Requirements
What you’ll need- B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
- 5 to 8 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry
- Good knowledge of ICH/GCP standards and applicable regulatory requirements
- Strong verbal and written communication skills in English
- Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines
- Excellent judgement and problem-solving skills
- Travel to research sites approximately 65% of the time
- Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint)
- Experience in dermatology is an asset
- Applicants must be legally able to work in the US
Benefits
Comp & perks- Permanent full-time position
- Vacation
- Sick days
- 401K
- Benefits
- Travelling position with teleworking allowance
- Ongoing learning and development
- Attractive advancement opportunities