Clinical Research Coordinator II

Johns Hopkins Medicine; Saint Petersburg (FL); On-site; USD 60,000 - 90,000; Full time

Job summary

Johns Hopkins Medicine in St. Petersburg, FL is seeking an experienced Clinical Research Coordinator II to support pediatric oncology trials.

The role coordinates complex studies, ensures regulatory compliance, and supports patient enrollment and follow-up within the Oncology Research Program. The ideal candidate has prior clinical research experience, strong organizational and communication skills, and the ability to manage multiple studies while adhering to GCP, FDA regulations, and

Qualifications

• Minimum Bachelor’s degree in health science, biology, nursing, public health, or related field.
• Experience coordinating clinical trials, ideally interventional studies.
• Knowledge of GCP, FDA regulations, informed consent, and IRB processes.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Coordinate and manage multiple oncology clinical trials from start-up through closeout.
• Screen, recruit, consent, and follow study participants.
• Review protocols and ensure compliance with research requirements.
• Prepare and submit regulatory documents to IRBs and sponsors.
• Maintain study records, source documentation, and regulatory files.
• Report adverse events and protocol deviations.
• Complete data entry and manage study information in electronic systems.
• Collaborate with investigators, research nurses, sponsors, and study team members.

Skills

Organizational skills

Communication skills

Problem-solving

Regulatory knowledge

Education

Bachelor's degree in health sciences or related field

Tools

EPIC

OnCore

REDCap

Rave

Veeva Vault

Job description

Clinical Research Coordinator II (CRC II) – Oncology Research Program

Location: St. Petersburg, FL
Schedule: Full-Time | Day Shift | On-Site (5 Days/Week)

This position is grant-funded for a period of five years and is therefore considered temporary in nature. While the role is expected to continue for the duration of the grant, ongoing employment is contingent upon continued funding.

Position Summary

We are seeking an experienced Clinical Research Coordinator II to support oncology clinical trials within our Pediatric Oncology Research Program. This role is responsible for coordinating complex clinical studies, ensuring regulatory compliance, supporting patient enrollment and follow-up, and collaborating with investigators, research staff, sponsors, and study participants.

The ideal candidate will have prior clinical research experience, strong organizational skills, and the ability to manage multiple studies while maintaining compliance with GCP, FDA regulations, and institutional policies.

Key Responsibilities

• Coordinate and manage multiple oncology clinical trials from start-up through closeout.
• Screen, recruit, consent, and follow study participants.
• Review study protocols and ensure compliance with research requirements.
• Prepare and submit regulatory documents to IRBs and sponsors.
• Maintain study records, source documentation, and regulatory files.
• Report adverse events, serious adverse events, and protocol deviations.
• Complete data entry and manage study information within electronic systems.
• Collaborate with investigators, research nurses, sponsors, and other study team members.

Required Qualifications

• Bachelor’s degree in a health science, biological science, nursing, public health, or related field.
• Clinical research coordination experience, preferably with interventional clinical trials.
• Knowledge of Good Clinical Practice (GCP), FDA regulations, informed consent, and IRB processes.
• Strong organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Oncology or pediatric oncology research experience.
• Experience with regulatory submissions and compliance.
• Clinical research certification (CCRC, CCRP, or equivalent).
• Experience using EPIC, OnCore, REDCap, Rave, Veeva Vault, or similar research systems.

Why Join Us?

Join a collaborative research team dedicated to advancing pediatric oncology care through innovative clinical trials. This is an opportunity to make a meaningful impact on patients and families while contributing to groundbreaking cancer research.

Please Note: This is an on-site position in St. Petersburg, Florida. Candidates must be able to work on campus five days per week and reside locally or be willing to relocate.