PSI CRO
Healthcare
SeniorClinicalResearchAssociate
Neural analysis suggests this role is
optimal for mid candidates.
“Senior Clinical Research Associate at PSI CRO. Skills: Clinical research, On-site monitoring, Site management. Prepare monitoring visits. Conduct monitoring visits”
What You'll Achieve.
Ensure timelines; Ensure targets; Ensure standards
Industry & Context.
Travel required
What They're Looking For.
Must Have
3 years of independent on-site monitoring experience, Experience in all types of monitoring visits in Phase II and/or III, Native Turkish, Full working proficiency in English (B2), Proficiency in MS Office applications, Valid driver's license, Ability to travel
Nice to Have
Experience supporting Oncology studies
What You'll Do.
Prepare monitoring visits
Conduct monitoring visits
Report monitoring visits
Support quality control
Review compliance monitoring
Act as contact for clinical investigators
Act as contact for vendors
Act as contact for support services
Handle Investigational Product
Use Investigational Product
Account for Investigational Product
Reconcile Investigational Product
Return Investigational Product
Deliver training of investigators
Deliver training of site staff
Deliver training of project teams
Involve in site identification
Involve in feasibility research
Support Regulatory Affairs
Procure site regulatory documents
Prepare presentations
Deliver presentations
Maintain study-specific tracking systems
Prepare for resolution of audit findings
Attend resolution of audit findings
How You'll Work.
Team & Collaboration
Project stakeholders; Clinical sites; Investigators; Project teams
Communication Scope
Presentations
Full Job Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. As a Clinical Research Associate II, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets, and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance. Hybrid role in Ankara, Turkey Your responsibilities will include: * Preparation, conduct, and reporting of all types of monitoring visits * Supporting quality control, such as compliance monitoring and reports review * Contact for clinical investigators, vendors and support services in regard to study progress * Proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and trial supplies at sites * Delivering training of investigators, site staff and project teams * Be involved in site identification process and feasibility research * Support to Regulatory Affairs in procurement of site regulatory documents * Preparation and delivering of presentations at Investigator’s Meetings * Maintenance of study-specific automated tracking systems * Preparation for and attendance at company’s audits; resolution of audit findings ## Qualifications * Degree in Life Sciences (or similar), or an equivalent combination of education, training & experience * 3 years of independent on-site monitoring experience * Experience in all types of monitoring visits in Phase II and/or III * Native Turkish and full working proficiency in English (B2) * Experience supporting Oncology studies is beneficial, but not esse
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