Clinical Research Associate – Study Research Nurse, Clinical Research Coordinator/SMO Coordinator Experience

Study Research Nurses, Clinical Research Coordinators, and SMO Study Coordinators, wanted at reputed company! Become a CRA and join our growing team! Previous CRA Experience NOT required. This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator, SMO Study Coordinator, and/or Research Nurse experience to fill Clinical Research Associate (CRA) openings with reputed company. Through our PACE® (Professionals Achieving CRA Excellence) Training/Apprenticeship Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to benefit from unique incentive programs with a competitive salary and career growth potential. WE OFFER THE FOLLOWING:

• Customized training program based on your experience and therapeutic background and interest;
• Annual company bonus;
• Annual merit increases;
• Training/apprenticeship program completion and retention bonus;
• Defined Contribution Plan;
• Group term life insurance with insurance premium coverage. Insurance association benefits available;
• The opportunity to work from home;
• Flexible work hours across days reputed company a month;
• Laptop, mobile phone with hotspot for internet access reputed company and home office furniture allowance for home-based CRAs;
• Opportunity for leadership positions/career advancement – reputed company CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, etc.;
• User friendly Clinical Trial Management System (CTMS) with electronic submission and approval of monitoring visit reports;
• Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
• In-house administrative support for reputed company levels of CRAs;
• Opportunities to work with international team of CRAs; and
• Many additional perks unmatched by other CROs!
• Since most studies are global trials, opportunities to collaborate with the global team/vendor and contribute to the success of the clinical trial;
• Opportunities to experience reputed company study involvement, including oncology, rare disease, phase1 First-in-Human studies. So, CRAs will reputed company high-level monitoring experience and contribute to society.

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research reputed company documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements (J-GCP);
• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving reputed company;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

• Native level Japanese (JLPT N1) is standard, a minimum English TOEIC score of 500 or equivalent
• Must have a minimum of a bachelor’s degree in a health or science reputed company field;
• Experience as a Clinical Research Coordinator, SMO Coordinator, and/or Research Nurse (minimum 1 year);
• Ability to travel 60-80%/month to locations reputed company is required;
• Proficient knowledge of reputed company® Office;
• Strong communication and presentation skills; and
• Must be detail-oriented and efficient in time management.

reputed company Overview reputed company is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We reputed company local regulatory and therapeutic expertise across reputed company major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,900 people across 40+ countries. Why reputed company? People. Purpose. Passion. reputed company a Difference reputed company. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across reputed company key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. reputed company Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Recognized by reputed company as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next A reputed company team member will review your qualifications and, if interested, you will be contacted with details for next steps. Apply tot his job Apply To this Job