Clinical Research Coordinator II

georgetown; Detroit (MI); On-site; USD 29,000 - 48,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Georgetown University is seeking a Clinical Research Coordinator II to lead coordination on multiple surgical service studies, including General Surgery and Transplant-related research. You will oversee regulatory submissions, data abstraction, entry, and study management, while supporting on-call coverage for enrollments and collaborating with PIs and the research team.

The role requires a Bachelor’s in a scientific field with 3+ years CRC experience, strong organizational and communication

Qualifications

• Bachelor's degree in a scientific or related field with at least 3 years CRC I or equivalent clinical research experience.

Responsibilities

• Lead coordination on multiple surgical service clinical studies.
• Manage regulatory submissions, data abstraction/entry/management, and study enrollment.
• Support on-call rotation to assist surgical and transplant enrollments.
• Interact with patients, research participants, and families.

Skills

Organizational skills

Critical thinking

Problem solving

Communication (verbal & written)

Data capture systems

Electronic medical records

Microsoft Suite / Google apps

Education

Bachelor's degree in a scientific or related field

Tools

OnCore

Job description

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

Requirements

Job Overview

The Clinical Research Coordinator II is a lead coordinator on multiple surgical services (General Surgery, Burn, Breast, Endocrine, Trauma, Colorectal, and Surgical Oncology) and possibly transplant clinical research studies, under the oversight of the Principal Investigator (PI) and direct supervision of the Assistant Research Manager in collaboration with a Research Director. The CRC II is responsible for the implementation of their assigned portfolio of clinical 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 surgical and transplant services and their enrollments.

Work Interactions

The Clinical Research Coordinator II works under the direct supervision of the Assistant Research Manager in collaboration with the Research Director and conducts 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 the sponsors, CROs, and IRBs.

Requirements and Qualifications

• Bachelor's degree in a scientific or related field with at least 3 years CRC I 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 Qualifications

• Experience with OnCore (Clinical Trials Management System).
• Certified clinical research certification (SoCRA or ACRP) preferred and is expected within one year of eligibility.

Work Mode Designation

This 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 a 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 projectedsalary 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

GU is an Equal Opportunity 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, matriculation, national origin, race, religion, personal appearance, political affiliation, 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.