Job Title: Sr. CRA

Location: Blue Bell, PA

Type: Direct Hire

Senior Clinical Research Associate, East, US Region

The Senior Clinical Research Associate (CRA) will report directly to the Senior Director Clinical Operations. This position has the responsibility of supporting the company’s 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 individual will be accountable for executing on the operational plan for clinical studies and leading site training, patient finding/recruitment, data collection and source data verification activities at the site level according to program timelines and quality targets. The Senior Clinical Research Associate will be a seasoned professional with a background in life sciences and end-to-end clinical operations experience from working within the biotech or pharmaceutical industry. Experience supporting clinical trials for rare disease indications is preferred.

Characteristics sought for a good cultural fit to the company include the ability to work collaboratively, strong organizational skills, excellent planning and communication and interpersonal skills, ability to think strategically and act independently, a “hands on” approach in the implementation of an agreed-upon plan, nimble problem-solving skills, an innate sense of urgency, creative thinking about what is possible in execution, and general positivity.

• All aspects of study site monitoring and management from site start-up activities to close-out of clinical sites, maintenance of study files, including routine monitoring (including, Confirmation/Follow-up Letters, trip report completion and follow-up) and other duties, as assigned

• Establish, grow, and maintain strong relationships with key study site staff (e.g., PIs, Sub-Is, SCs, Genetic Counselors, Dietitians, Pharmacy Directors)

• Recruitment of potential investigators, preparation of IRB/EC submissions, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned

• Independently perform CRF review; query generation and resolution against established data review guidelines per SOPs or data management systems as assigned by supervisor

• 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

• Hold clinical sites accountable to study timelines for start-up, patient recruitment strategies, enrollment, and quality data deliverables

• A BA/BS degree required; advanced degree with scientific or health-care training preferred

• Minimum of at least 3-4 years of Onsite Clinical Monitoring experience. At least 1-year additional experience in related field

• Advanced site monitoring; and study site management skills

• Thorough knowledge of monitoring procedures and strong understanding of the drug accountability process

• 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 20%. Valid driver's license and current passport

  Operations

  June 2024

  Fulltime, Onsite, Blue Bell, PA

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.