Clinical Research Coordinator II

Georgetown University; Washington, Northern (District of Columbia, KY); On-site; USD 29,000 - 48,000; Full time

Benefits offered by this job

Medical insurance

Tuition assistance

Work-life balance benefits

Job summary

Georgetown University seeks a Clinical Research Coordinator II to lead coordination on surgical service studies, under PI supervision. You will handle regulatory submissions, data abstraction, and participant enrollment within a multidisciplinary team at the university medical center.

The role requires a Bachelor’s in a scientific field and 3+ years CRC experience, with solid knowledge of FDA/OHRP regulations and ICH GCP. On-campus work arrangement is specified, with competitive benefits.

Qualifications

• Bachelor's degree in a scientific or related field with at least 3 years CRC I or equivalent clinical research experience.
• Working knowledge of FDA and OHRP regulations, ICH GCP.
• Strong organizational, problem-solving, and communication skills.

Responsibilities

• Lead coordination on multiple surgical service studies with regulatory submissions.
• Perform data abstraction/entry/management and participant screening/enrollment.
• Manage moderate to high-level complexity studies and support on-call coverage.

Skills

Clinical research coordination

Regulatory compliance

Communication skills

Data management

Microsoft Office / data systems

Education

Bachelor's degree in a scientific or related field

Tools

OnCore

Electronic Medical Records

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 (CRC 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 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

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.

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.

We’re a leading research university with a heart. Founded in the decade that the U.S. Constitution was signed, we’re the nation’s oldest Catholic and Jesuit university. Today we’re a forward-looking, diverse community devoted to social justice, restless inquiry and respect for each person’s individual needs and talents. Grounded in our Jesuit, Catholic identity, the Spirit of Georgetown undergirds everything we do. Watch this video to learn more. Learn how HR CARES for faculty and staff, nurturing an environment of mutual respect where imaginations flourish and ideas are realized to positively impact the world.

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.