Job Information
System One Senior CRA in Blue Bell, Pennsylvania
Job Title: Sr. CRA
Location: Blue Bell, PA
Type: Direct Hire
Requirements:
BA/BS degree required; advanced degree with scientific or health-care training preferred
COVID-19 vaccination required
Minimum of at least 3-4 years of Onsite Clinical Monitoring experience. At least 1-year additional experience in related field
Advanced site monitoring; study site management; and registry administration skills
Ability to train and supervise junior staff; resolve project related processes
Thorough knowledge of monitoring procedures and strong understanding of the drug accountability process
Valid driver's license and current passport
Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Strong knowledge of rare disease clinical research highly desired
Knowledge and experience in gene therapy and gene editing, preferred
Experience with pediatric, in-patient / hospital-based studies, highly desired
Experience monitoring global clinical trials for a product through all clinical phases of clinical development
Demonstrated career success as a seasoned CRA, effective organizational skills, excellent verbal and written communication skills and high attention to detail
Excellent working knowledge of FDA & ICH/GCP/CFR regulations and guidelines
Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
A professional who inspires trust and confidence in others. A resourceful, energetic self-starter who can shift between collaboration and execution
Possess unquestionable integrity with the highest ethical standards
Willingness and ability to participate in domestic and international travel, as required, up to 30%.
Responsibilities:
All aspects of study site monitoring and management including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Organize and conduct presentations at Investigator Meetings
Participate in the development of protocols and Case Report Forms and clinical trial reports as assigned
Recruitment of potential investigators, preparation of IRB/EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
Negotiate study budgets with potential investigators and assist the CRO legal departments with statements of agreements as assigned
Independently perform CRF review; query generation and resolution against established data review guidelines per SOPs or data management systems as assigned by management
Domestic and international travel may be required and is an essential function of the job; prepare accurate and timely trip reports; review progress of projects and initiate appropriate actions to achieve target objectives
Conduct, report and follow-up on Shadow Monitoring Visits (Quality Spot Checks) when requested for CRO or monitors
Manage the operational, quality, and financial aspects of clinical trial sites
Support the study project plan, including timeline, budget, and resources
Participate in protocol, CRF, and study plans strategy development as appropriate
Develop patient recruitment planning and strategy at the site levels
Proactively identify potential study issues/risks and recommend solutions
Maintain systems (eTMF, CTMS, EDC, etc.) that track progress throughout the duration of the program
Manage all site activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
Ensure appropriate clinical trial supplies are planned and ordered in time for all assigned sites
Develop and conduct site training materials for disease state and clinical protocol objectives
Hold clinical sites accountable to study timelines for start-up, patient recruitment strategies, enrollment, and quality data deliverables
Report progress of key study milestones and data deliverables to supervisor on a weekly basis
Collaborate effectively with vendor partners and internal functions to develop and execute strategies to expedite enrollment of clinical studies
Ensure supporting documentation (e.g., case report forms, monitoring plans, data management plans, safety plans) protocol objectives and operational efficiencies are followed
Accountable for the ongoing review of EDC data and issuance of queries in collaboration with CROs/vendors
Establish, grow, and maintain strong relationships with study sites and investigators
Review monitoring reports, conduct co-monitoring visits and support resolution of issues related to sites as needed
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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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