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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical site monitoring, regulatory compliance, and ICH-GCP guidelines while effectively coordinating study activities and training site staff. Proficient in managing clinical trial processes and ensuring data integrity across various phases of clinical research.
Highest-signal resume keywords
Clinical Site MonitoringICH-GCP ComplianceEDC Systems ProficiencyPhase I–IV Clinical Trials ExperienceStrong 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 Study Plans ExecutionData Review and Query ResolutionOnsite and Remote MonitoringProtocol TrainingISF and TMF ReviewInvestigational Product CoordinationStudy Data DocumentationProject Timeline ManagementProblem-SolvingAttention to Detail
Soft Skills
Interpersonal SkillsOrganizational SkillsAbility to Work IndependentlyCross-Functional Team CollaborationSense of Urgency
Tools & Technologies
Medidata RaveOracle InFormIRTETMFCTMSMicrosoft Office Suite
Certifications & Qualifications
ACRP CertificationSr. CRA Designation
Industry Keywords
Clinical TrialsHealth SciencesLife SciencesPharmacyNursingRegulatory Requirements
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- Independently perform, coordinate, and oversee clinical site monitoring services
- Assess protocol and regulatory compliance according to company and sponsor processes, ICH/GCP guidelines, and local regulations
- Serve as the primary liaison between the sponsor/Alimentiv and investigative sites
- Execute clinical study plans
- Conduct and document onsite and remote monitoring, close-out, qualification, and initiation visits
- Review study data against source documents and resolve or escalate data queries
- Coordinate shipment and delivery of investigational products, laboratory supplies, ePROs, and study documents
- Train site staff on protocols, study plans, systems, and ICH-GCP
- Review ISF and TMF for accuracy, timeliness, and completeness
- Act as primary contact for investigational site questions and issues
- Support site activation, recruitment milestones, study communications, and project timelines
- Participate in study meetings, investigator meetings, audits, and inspections
- Mentor CRA I and II and perform CRA assessment or co-monitoring visits
- Support hiring interviews and process improvement initiatives
Requirements
What you’ll need- 4–6 years of related experience
- (Honors) Bachelor’s degree
- Fluent in written and verbal English
- An equivalent combination of education and experience may be considered
- Thorough knowledge of ICH-GCP and local regulatory requirements
- Proficiency with EDC systems such as Medidata Rave and Oracle InForm, IRT, eTMF, CTMS, and Microsoft Office Suite
- Ability to travel up to 40–60%, depending on project assignment and site geography
- Health Sciences, Life Sciences, Pharmacy, or Nursing degree preferred, or Sr. CRA and/or ACRP Certification/Designation
- Experience with Phase I–IV clinical trials preferred
- Valid driver’s license
- Strong interpersonal and problem-solving skills
- Ability to work independently and within cross-functional teams
- Strong communication and organizational skills, attention to detail, and sense of urgency
Benefits
Comp & perks- Full-time, permanent employment
- Home-based work arrangement
- Regular travel required
- Opportunity to mentor and support CRA I and II
- Participation in process improvement initiatives and development of best practices