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Responsibilities : The Department of Medicine Clinical Trial Program is seeking a skilled Clinical Research Associate to oversee, manage and participate in research activities. Providing oversight of clinical research sites compliance with ICH/Good Clinical Practices (GCP), governing SOPs (standard operating procedures) and clinical study protocols. This includes responsibility for research assessment and patient intervention under the supervision of the Principal Investigator. Responsible for regulatory coordination of clinical research studies, preparation, submission and maintenance of regulatory files to fulfill research requirements. Additional responsibilities include regulatory compliance, patient recruitment and enrollment, data collection, research chart documentation, quality assurance, report preparation, protocol information dissemination to health care professionals, patients and their family members. Work may be assigned by Senior Management, and assignments may be changed on an as-needed basis in order to ensure that studies and patient care needs are handled appropriately and in a timely manner. Travel to other locations may be required.
Required Skills:
- A multi-tasked individual with a minimum 2 years of experience in a clinical research coordinator role.
- College degree in medicine, science, health, or equivalent.
- Performs management of research activities to ensure the collection of accurate clinical data within given timeline.
- Knowledge of ICG GCP guidelines and expertise to review, evaluate medical data and all applicable local laws and regulations.
- Demonstrated knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc
- Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC)
- Track progress of clinical studies with regard to budget, study milestones, and deadlines.
- Recruiting & enrolment of patients who meet eligibility criteria, scheduling, completing CRFs.
- Able to solve complex problems, prioritize multiple tasks, plan proactively and accomplish goals within project in a dynamic team environment
- Participate in study audits, as applicable
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.
