Senior Clinical Research Associate – Acute Schizophrenia
Worldwide Clinical Trials
Senior Clinical Research Associate, Sponsor Dedicated – Oncology
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Colorado, New Mexico, Utah, Washington • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- 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.
- Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP).
- Conducts Source Document Review of appropriate site source documents and medical records.
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
- Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Supports subject/patient recruitment, retention and awareness strategies.
- Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Requirements
- 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
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Basic level of critical thinking skills expected.
- Ability to manage required travel of up to 75% on a regular basis
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- eligibility to participate in Employee Stock Purchase Plan
- flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
site qualificationsite initiationinterim monitoringsite managementclose-out visitsclinical data integrityquery resolutiondata entrysource document reviewcase report form (CRF)
Soft skills
communication skillspresentation skillsinterpersonal skillscritical thinkingjudgmentdiligenceproblem-solvingaction planningevaluationrecommendation
Certifications
Bachelor’s degreeRN
