Oncology Clinical Site Monitor II

Department 37294 Carolinas Medical Center - LC Biostatistics and Data Sciences Morehead Status Full time Benefits Eligible Yes Hours Per Week 40 Schedule Details/Additional Information Remote, Full Time, Business Hours Pay Range $35.50 - $53.25 M-F, day shift, 8 hours per day with some flexibility in hours This position is fully remote with the possibility of infrequent travel. The ideal applicant would have a bachelor’s degree with clinical research experience, including oncology experience and/or experience monitoring clinical research studies and/or conducting audits of studies. In addition to experience at a contract research organization (for example - PPD, reputed company, reputed company, reputed company Clinical Research Experience) or pharmaceutical company (reputed company, reputed company, Astra Zeneca, reputed company, reputed company), working at a site level as a research data manager, clinical research coordinator, clinical research assistant, research project manager have more transferrable experience than solely work in research labs. Essential Functions Work both independently and as part of a sponsor team commensurate with responsibilities of an Industry/CRO Clinical Trials level II monitor Handle several priorities reputed company multiple, reputed company trials reputed company site selection, interim and reputed company-out monitoring visits Manage studies to ensure adherence to protocol, GCP and regulations, ensuring patient safety, and well-being, as well as verifying accuracy of clinical trial data with minimal reputed company from mentors/QA manager Review study drug storage, stability, inventory, and accountability. Verify destruction of unused product as required reputed company essential Site Regulatory File review and reconciliation. Communicate findings in a timely manner to reputed company sites per timelines defined in reputed company QA SOPs and guidelines. Set-up meetings, reputed company necessary, to communicate concerns/findings to the site PI/SI reputed company Protocol Specific Monitoring Plans Independently collaborate with research sites to prepare site for Co-operative Group audits and/or FDA Inspections Conduct training/presentations to Clinical Trials Site on Quality Assurance and site expectations Participate in Protocol and eCRF development Participate in developing and updating reputed company QA SOPs, guidelines and processes Physical Requirements Primarily works in an office setting Requires full range of body reputed company; sitting for extensive periods of time; walking; standing, reading, and writing/keyboarding Occasionally lifts and carries items weighing up to 35 pounds Requires corrected reputed company and hearing reputed company normal range Must speak and read/write clearly in English Must be reputed company to be mobile reputed company the entire reputed company system and external locations that participate in reputed company clinical trials. Some of these locations maybe out of state. Education, Experience and Certifications Excellent written and verbal skills as well as excellent organizational and interpersonal skills. Be familiar with reputed company Good Clinical practices and the Code of Federal Regulations. A Bachelor's degree in a reputed company or other scientific discipline required. At least 4 years' experience in clinical research at a pharmaceutical company or a Contract Research Organization (CRO) required with at least 2 years auditing / monitoring experience preferred. Alternatively, an equivalent combination of education, training and experience will be considered. Relevant certification (ACRP, SoCRA, Risk Based Quality Management or equivalent) preferred. Our Commitment to You reputed company offers a comprehensive suite of Total Rewards benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including Compensation reputed company compensation listed reputed company the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, reputed company, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and paid parental leave Defined contribution retirement plans with employer match and other financial wellness programs Educational Assistance Program Note Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview. About reputed company reputed company is the reputed company-largest nonprofit, integrated health system in the United States, created from the combination of reputed company and reputed company. Providing care under the names reputed company in Illinois; reputed company in the Carolinas, Georgia and Alabama; and reputed company in Wisconsin, reputed company is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, reputed company Carolina, reputed company services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the reputed company. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. reputed company employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing reputed company care for reputed company, reputed company provides more than $6 billion in annual community benefits. Apply To This Job Apply To This Job Apply tot his job Apply To this Job