Georgetown University
Clinical Research Coordinator
Georgetown University, Washington, District of Columbia, us, 20022
Overview
The Clinical Research Coordinator II (CRCII) is the lead coordinator on multiple transplant (liver, kidney, pancreas, bowel) and GI clinical research studies, under the oversight of the Principal Investigator (PI) and direct supervision of the Clinical Trials Supervisor as well as the Research Director. The CRCII is responsible for the implementation of their assigned portfolio of studies, including regulatory submissions, data abstraction/entry/management, participant screening and enrollment, and study management. Given the role is an intermediate level position, the coordinator will manage moderate to high-level complexity studies. The role involves supporting the research on-call rotation amongst the research team to support transplant surgeries, enrollments, and the sample collection program. Work Interactions
The Clinical Research Coordinator II works under the direct supervision of the Clinical Trials Supervisor in partnership with the oversight of Research Director and conducts the studies under direct oversight of the Principal Investigators (PIs). This individual will interact directly with patients, research participants, and their families. They work within the multidisciplinary team of the healthcare system and the university medical center, including the clinical research office, sponsored programs financial office, research development services, respective grants managers, and serve as primary point of contact with sponsors, CROs, and IRBs. Requirements and Qualifications
Bachelor's degree in a scientific or related field with at least 3 years CRCI or equivalent clinical research experience. An equivalent combination of education and experience may be substituted. Working knowledge of the federal regulations and federal agencies including the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), as well as familiarity with the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH GCP). Strong organizational, critical thinking, and problem-solving skills. Working knowledge of clinical trials contracting and budgeting, including understanding of Medicare Coverage Analysis (MCA) and clinical trials billing compliance, both industry and non-industry. Excellent demonstrated interpersonal, verbal, and written communication skills. Strong proficiency in Microsoft, Google, data capture systems, electronic medical records, and other computer applications. Preferred
Experience with OnCore (Clinical Trials Management System). Certified clinical research certification (SoCRA or ACRP) preferred and required within one year of eligibility. Work Mode Designation
The position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff and AAP positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation. Pay Range
The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $21.16 - $35.29 Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors. EEO Statement
Georgetown University is an Equal Opportunity/Affirmative Action Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other characteristic protected by law. Benefits
Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website. Note: This refined description removes duplicate marketing lines, extraneous site notices, and non-essential content while preserving the core responsibilities and qualifications of the Clinical Research Coordinator II role at Georgetown University.
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The Clinical Research Coordinator II (CRCII) is the lead coordinator on multiple transplant (liver, kidney, pancreas, bowel) and GI clinical research studies, under the oversight of the Principal Investigator (PI) and direct supervision of the Clinical Trials Supervisor as well as the Research Director. The CRCII is responsible for the implementation of their assigned portfolio of studies, including regulatory submissions, data abstraction/entry/management, participant screening and enrollment, and study management. Given the role is an intermediate level position, the coordinator will manage moderate to high-level complexity studies. The role involves supporting the research on-call rotation amongst the research team to support transplant surgeries, enrollments, and the sample collection program. Work Interactions
The Clinical Research Coordinator II works under the direct supervision of the Clinical Trials Supervisor in partnership with the oversight of Research Director and conducts the studies under direct oversight of the Principal Investigators (PIs). This individual will interact directly with patients, research participants, and their families. They work within the multidisciplinary team of the healthcare system and the university medical center, including the clinical research office, sponsored programs financial office, research development services, respective grants managers, and serve as primary point of contact with sponsors, CROs, and IRBs. Requirements and Qualifications
Bachelor's degree in a scientific or related field with at least 3 years CRCI or equivalent clinical research experience. An equivalent combination of education and experience may be substituted. Working knowledge of the federal regulations and federal agencies including the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), as well as familiarity with the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH GCP). Strong organizational, critical thinking, and problem-solving skills. Working knowledge of clinical trials contracting and budgeting, including understanding of Medicare Coverage Analysis (MCA) and clinical trials billing compliance, both industry and non-industry. Excellent demonstrated interpersonal, verbal, and written communication skills. Strong proficiency in Microsoft, Google, data capture systems, electronic medical records, and other computer applications. Preferred
Experience with OnCore (Clinical Trials Management System). Certified clinical research certification (SoCRA or ACRP) preferred and required within one year of eligibility. Work Mode Designation
The position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff and AAP positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation. Pay Range
The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $21.16 - $35.29 Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors. EEO Statement
Georgetown University is an Equal Opportunity/Affirmative Action Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other characteristic protected by law. Benefits
Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website. Note: This refined description removes duplicate marketing lines, extraneous site notices, and non-essential content while preserving the core responsibilities and qualifications of the Clinical Research Coordinator II role at Georgetown University.
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