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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, ensuring compliance with ICH-GCP and local regulations while effectively managing site activation, recruitment, and training. Proficient in utilizing EDC, IRT, eTMF, and CTMS to maintain data integrity and support clinical trial processes.
Highest-signal resume keywords
Clinical Site MonitoringICH-GCP ComplianceEDC ProficiencySite ManagementMentoring Junior CRAs
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 Research ExperienceSite QualificationData Integrity ReviewProtocol Deviation ResolutionStudy Documentation MaintenancePatient RecruitmentProblem-SolvingPrioritisationIndependent WorkTravel Willingness
Soft Skills
Excellent CommunicationInterpersonal SkillsRelationship ManagementOrganisational Skills
Tools & Technologies
EDCIRTETMFCTMSMicrosoft OfficeMedidata RaveOracle InForm
Certifications & Qualifications
Bachelor’s Degree in Life SciencesValid Driver’s Licence
Industry Keywords
Clinical TrialsPhase I–IV TrialsSOPsInvestigative SitesAuditsInspections
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits across Serbia and Croatia
- Ensure investigative sites comply with protocols, ICH-GCP, applicable regulations, SOPs and project requirements
- Act as primary contact for assigned sites and resolve questions, issues, action items and protocol deviations
- Review clinical trial data, source documentation and study systems for accuracy, completeness, data integrity and compliance
- Support site selection, activation, recruitment, study milestones and patient recruitment targets
- Train sites on protocols, study systems, processes and applicable requirements
- Maintain essential study documentation, including ISF and TMF
- Collaborate with sponsors, project teams, vendors and investigative sites
- Participate in audits, inspections, Investigator Meetings, study meetings and other project activities
- Mentor CRA I and II colleagues, participate in co-monitoring and CRA assessments, and contribute to process improvement
Requirements
What you’ll need- Bachelor’s degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline
- 4–6 years of relevant clinical research experience
- Strong clinical site monitoring experience from site start-up through close-out
- Thorough knowledge of ICH-GCP, clinical research principles and applicable local regulatory requirements
- Proficiency with EDC, IRT, eTMF, CTMS and Microsoft Office
- Strong understanding of site management, including site activation, recruitment, training, issue resolution and essential documentation
- Excellent communication, interpersonal and relationship-management skills
- Strong organisational, problem-solving and prioritisation skills
- Ability to work independently, exercise sound judgement and manage competing priorities
- Willingness and ability to travel approximately 40–60%
- Valid driver’s licence required
- Fluent written and verbal English
- Experience with Phase I–IV clinical trials, Medidata Rave or Oracle InForm, and mentoring junior CRAs preferred
Benefits
Comp & perks- Education Reimbursement program for full-time employees
- Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility)
- One time office setup allowance for a scanner/printer, extra monitor, office furniture, etc.
- Working while visiting program – up to 4 weeks per year
- Flexible Summer Hours Program from May – September
- Employee referral incentive
- Full-time employees become beneficiaries of the Alimentiv Trust after one year of employment and permanent members after 5 years of employment
- Optional formal mentorship program (Alimentorship)
- Country/region annual social events in person
- Leadership development programs for people leaders in accordance with seniority
- Social committee and other optional initiatives
- Additional benefits may be available depending on country of employment and local policies and eligibility
