Enrollment Coordinator - Clinical Research

Parexel; Baltimore (MD); On-site; USD 34,000 - 43,000; Full time

Benefits offered by this job

Health insurance

401k match

Life insurance

Paid time off

Job summary

Parexel in Baltimore, MD, is seeking an Enrollment Coordinator I to join the Clinical Enrollment team onsite. You will screen, enroll, and manage volunteers for early-phase trials in compliance with protocol requirements, CFR/ICH GCP guidelines, and quality standards.

The role collaborates with physicians, study staff, and sponsors, supports training, data entry, and ensures timely enrollment, documentation, and adherence to SOPs and regulatory guidelines.

Qualifications

• Bachelor's degree in a life science, nursing, healthcare-related field, or equivalent experience. BSN, RN, or foreign MD preferred.
• Minimum of 2 years of clinical research, clinical enrollment, or clinical coordinator experience
• Experience working with clinical protocols, regulatory requirements, and data entry systems preferred.

Responsibilities

• Screen potential clinical trial volunteers according to protocol specific requirements and CFR/ICH GCP guidelines.
• Ensure all study laboratory and medical tests are completed and eligibility requirements specific to assigned studies are met.
• Ensure completion of enrollment for assigned studies and manage process closely to minimize waste.
• Ensure quality control (QC) of all electronic and paper source documents.
• Assist in reviewing Informed Consent Documents, Study Protocols, Source Documents, and Case Report Forms during development.
• Ensure screening ratio and marketing expenditures are maintained within study specific budget.
• Participate in team project meetings and ensure regular updates for assigned studies.
• Develop and present training material to department staff for assigned studies.
• Arrange for pre/post procedure lab work to be performed and initiate follow up as required.
• Ensure follow up to all queries related to screening and enrollment of assigned studies.
• Collect, organize, and prepare data for physician review and enter data into database when required.
• Support SOPs, GCP, and all work processes to ensure efficient and compliant clinical operation of the EPCU.

Skills

Clinical research

Regulatory compliance

Data entry

Education

Bachelor's degree in life sciences or healthcare

Tools

Clinical data systems

Electronic health records

Job description

Job Title: Enrollment Coordinator I

Work Location: onsite in Baltimore, MD

Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans.

As a Clinical Enrollment Coordinator, you will serve as a key member of the clinical research team, ensuring study participants are enrolled, screened, and managed in compliance with protocol requirements, regulatory guidelines, and quality standards. This role provides broad exposure to multiple aspects of clinical research while working collaboratively with physicians, research staff, project teams, and study sponsors to support the successful execution of clinical trials.

What you’ll do after training is completed (including but not limited):

• Screen potential clinical trial volunteers according to protocol specific requirements and CFR/ICH GCP guidelines. Ensure all study laboratory and medical tests are completed and the eligibility requirements specific to assigned studies are met
• Ensure all established timelines relating to area of responsibility and assigned projects are met
• Ensure completion of enrollment for assigned studies and manage process closely to minimize waste
• Ensure quality control (QC) performance of all electronic and paper source documents
• Assist in reviewing Informed Consent Documents, Study Protocols, Source Documents, and Case Report Forms during development
• Ensure screening ratio and marketing expenditures are maintained within study specific budget
• Participate in team project meetings and ensure regular updates for assigned studies
• Develop and present training material to department staff for assigned studies
• Arrange for pre/post procedure lab work to be performed and initiate follow up as required
• Ensure follow up to all queries related to screening and enrollment of assigned studies
• Collect, organize, and prepare data for physician review. Enter data into database when required. Ensure all paper source documents are completed as required by protocol. Assist physician with completing flow sheets in medical record and progress note. Update and maintain contents of the Clinical Study File
• Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the EPCU

Your Profile

• Bachelor's degree in a life science, nursing, healthcare-related field, or equivalent experience. BSN, RN, or foreign MD preferred.
• Minimum of 2 years of clinical research, clinical enrollment, or clinical coordinator experience
• Experience working with clinical protocols, regulatory requirements, and data entry systems preferred.

Base Pay Range: $25.00 to $31.00 per hour

Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.

In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and additional total rewards incentives.

Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.