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SoluStaff is actively recruiting a Senior Clinical Research Associate (CRA) for its customer, a preclinical stage gene editing company focused on developing therapies that utilize mutation-agnostic in vivo gene insertion, or knock-in, therapy for the treatment of rare diseases. The Senior CRAwill report directly to the Senior Director Clinical Operations. This position has the responsibility of supporting the companys clinical operations function in close collaboration with research, development, and other functions. This includes working directly with the study team, vendors, and clinical study sites to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP/CFR regulatory guidelines, as well as in line with company goals, timelines, and budgets. This position provides input and necessary support and oversight for high quality execution of global clinical trials. This position also provides support for documentation of important clinical trial data and necessary operational information to prepare for data base lock and study closure. The candidate must live in the the Philadelphia region and be willing to work in the Blue Bell, PA office at least 3-4 days/week when not traveling to the sites. The candidate MUST have in-hospital pediatric experience, preferably in rare disease with cell therapies.

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 iECURE/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 iECURE 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

Requirements

• A BA/BS degree required; advanced degree with scientific or health-care training preferred
• Strong knowledge of rare disease clinical research highly desired
• Knowledge and experience in gene therapy and gene editing, preferred
• 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%.

• 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

• Experience with pediatric, in-patient / hospital-based studies, highly desired

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Paid Time Off (Vacation, Sick & Public Holidays)