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Site Care Partner, Senior CRA - Sponsor Dedicated
Syneos HealthSite Care Partner managing site relationships for clinical studies in Belgium. Leading site start-up activities and ensuring project objectives are met with accountability in the clinical team.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Good Clinical PracticeICH Guidelinesclinical monitoringsite managementsite recruitment planningaudit readinesscritical thinkinginformed consent documentationpharmacovigilanceproject management
Soft Skills
communicationpresentationinterpersonaladaptabilityteam collaborationproblem-solvingleadershiporganizationalrelationship managementtime management
Tools & Technologies
clinical trial management systemsdata management softwareelectronic data captureMicrosoft Officeproject management toolsregulatory compliance toolscommunication platformsinvestigator meeting toolsmonitoring visit toolsaudit preparation tools
Certifications & Qualifications
Bachelor’s degreeRegistered Nurse (RN)clinical research certification
Industry Keywords
clinical research associatesite activationregulatory requirementsclinical data integrityprotocol deviationinvestigator sitessubject matter expertmonitoring visitsproject scopebudget management
About the role
Key responsibilities & impact- The Site Care Partner is the main point of contact for investigative sites to develop and maintain site relationships and to drive efficient operational delivery with high quality
- Supports processes to optimize country & site selection activities and leads site start-up activities through activation
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
- Demonstrates diligence in protecting the confidentiality of each subject/patient.
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Leads site management from start up, conduct, and closeout including site recruitment planning and delivery
- Acts as operational point of contact for site-level questions, liaising with and escalating to appropriate team members
- Acts as a local/country Subject Matter Expert for regulations and operational implementation
- Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- Must be able to quickly adapt to changing priorities to achieve goals / targets.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
- Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Requirements
What you’ll need- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Multiple years of CRA experience in Belgium
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Moderate level of critical thinking skills expected.
- Fluency in both Dutch and French
- Ability to manage required travel for monitoring visits
Benefits
Comp & perks- We are passionate about developing our people, through career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- We are committed to building an inclusive culture – where you can authentically be yourself