Job Description
We are seeking an experienced professional who can immediately provide hands-on monitoring and data-readiness support for an active, sponsor-led Phase 1 gene therapy study approaching an interim data freeze. The candidate will partner with CTM/COL to ensure site-related monitoring activities through close-out activities are conducted as per GCP and regulatory requirements. Responsibilities include completing monitor trip report reviews, site audit reports, and on-site assessments for quality, GCP, and regulatory compliance.
Responsibilities
- Data cleaning and monitoring gene therapy clinical studies for adherence to protocol, ICH/GCP, SOP's, and follows Clinical Monitoring Plan; i.e. on-site and remote visits, create trip reports in Veeva, monitor metrics of site performance.
- Ensure the quality of data generated from clinical sites and assist in resolving subject eligibility/protocol deviations issues and confirm accuracy of clinical data.
- Work closely with CTM/Data Management lead/COL and follow up on issues to ensure they are closed within the expected timeframe.
- Track essential documents are received/approved & filed for the duration of the study.
- Review/approve site ICF's for continuity and follow up with functional leads as appropriate.
- Coordinate activities from third-party vendors, monitor metrics and study status (accruals and attrition), query tracking, non-compliance & protocol deviations.
- Perform other work-related duties as assigned, i.e. data entry.
Skills
- Senior-level independent monitoring-PSV/SIV/IMV/COV
- Veeva Vault proficiency, including eTMF/CTMS and monitoring documentation
- Gene therapy / rare disease clinical trial experience strongly preferred
- Complex early-phase (Phase 1/2) trial experience
- On-site and remote SDV/SDR
- Rapid data-cleaning / database lock or interim freeze support
- EDC proficiency, ideally Medidata Rave
- Regulatory binder / ISF review and reconciliation
- Protocol deviation identification, documentation, and follow-up
- AE/SAE and safety data review/reconciliation
- Source documentation review and ALCOA /GCP compliance
- Site issue identification, escalation, and follow-through
- Site relationship management, particularly academic/rare-disease sites
- Investigational product / gene therapy administration documentation review
- IRB/IBC and essential document familiarity
- Ability to independently prioritize high-volume outstanding SDV and close monitoring gaps
- Strong written monitoring reports and action-item follow-up
- Ability to travel immediately/frequently for on-site monitoring
- Minimal onboarding required / able to become productive quickly
Education
- Bachelor's or Master's degree in life sciences or related field preferred
- Equivalent combination of education and relevant clinical research experience considered
- ACRP or SOCRA certification preferred, but not required
Join our team in beautiful San Diego, CA, where you can advance your career in a dynamic and innovative environment while enjoying the benefits of living in a vibrant coastal city.
Pandologic. Keywords: Business Intelligence Manager, Location: San Diego, CA - 92108
Numbers & Facts
| Location | San Diego, CA |
| Industry | Staffing/Employment Agencies |
| Company Size | 10 to 19 employees |
| Year Founded | 2017 |
| Website | http://www.whitecapsearch.com |
About Company
At WhiteCap Search we are breaking away from the traditional approach of agency recruiting to enhance the experience of the job search process. From companies looking to hire top talent, to job seekers looking for the best next step in their careers, WhiteCap Search is focused on finding the optimal fit for all parties involved.
Founded by a diverse team of recruiting experts, we have developed a strong foundational knowledge of each industry for which we recruit. We believe in combining best in class technology with rigid ethical standards to create a positive and tailored approach for each employer and job seeker.
The WhiteCap Search team is uniquely positioned to handle both permanent and temporary searches for a wide variety of job functions across all industries. We optimize our extensive network and cutting-edge technology to deliver results successfully and seamlessly. Utilizing our strong foundational knowledge of each industry for which we recruit, we engage our clients as partners by creating a customized plan for every search. We source job seekers proactively so that employers have unparalleled access to both active and passive job seekers. Our rigorous and consistent screening processes enable us to present top, qualified talent to our clients quickly, making the recruitment process as efficient as possible. Our temporary and consulting services provide employers and job seekers with flexibility. Whether it’s providing support during particularly busy times of the year, covering for an employee during a leave of absence or assisting with special projects, we can handle any of our clients’ temporary staffing needs. Additionally, our temporary-to-permanent staffing solutions provide both the job seeker and employer with the ability to evaluate whether they are the right fit for each other before making a long-term commitment.
Skills
- Administrator Documentationunmatched
- Biologyunmatched
- Business Intelligenceunmatched
- Clinical Dataunmatched
- Clinical Monitoringunmatched
- Clinical Trialunmatched
- Data Cleaningunmatched
- Data Entryunmatched
- Data Managementunmatched
- Data Qualityunmatched
- Diseaseunmatched
- Documentationunmatched
- Documentation Reviewunmatched
- Electronic Data Capture (EDC)unmatched
- Establish Prioritiesunmatched
- Follow Throughunmatched
- GCP (Good Clinical Practices)unmatched
- Gene Therapyunmatched
- ICH Regulationsunmatched
- IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
- Identify Issuesunmatched
- Investigational New Drug (IND)unmatched
- Metricsunmatched
- Onboardingunmatched
- Performance Metricsunmatched
- Reconciliationunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Relationship Managementunmatched
- Reporting Skillsunmatched
- Sales Managementunmatched
- Site Evaluationunmatched
- Site Initiationunmatched
- Society of Clinical Research Associates (SoCRA)unmatched
- Standard Operating Procedures (SOP)unmatched
- Willing to Travelunmatched
- Writing Skillsunmatched
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