Clinical Research Coordinator I

ObjectiveHealth•Laurel, MD

About The Position

ObjectiveHealth is seeking a qualified, full-time Clinical Research Coordinator to work directly with patients and support clinical research studies. The role involves coordinating assigned studies and patients, carrying out clinical trial activities and direct patient care, maintaining study documentation and regulatory compliance, and communicating with research team members and external partners. Studies may involve Gastroenterology, Urology, Dermatology, and/or Oncology. The coordinator is expected to learn and use company-provided technologies and embody the company’s values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication.

Requirements

Strong desire to work directly with patients and skill in patient interaction and care.
Certification such as an MA, phlebotomy, or similar.
Ability to perform the activities required to conduct an IRB-approved clinical trial protocol, including patient identification, screening, randomization, enrollment, and clinic visits.
Ability to perform or assist with patient care activities such as consenting patients, physical assessments, blood draws, medication administration, and ECGs.
Attention to detail in data entry, regulatory compliance, study visits, study setup and maintenance, and protocol adherence.
Strong communication skills for fostering relationships with the research team, PIs, sponsors, monitors, and others.
Ability to stay focused while managing multiple protocols, IRB responses, audit findings, AE/SAE tracking, and eSource materials.
Legal authorization to work in the United States; work visas are not currently accepted.

Responsibilities

Conduct IRB-approved clinical trial activities, including identifying, screening, randomizing, and enrolling patients and conducting clinic visits.
Perform and assist with direct patient care activities, including obtaining informed consent, physical assessments, blood draws, medication administration, and ECGs.
Maintain accurate data entry and regulatory compliance, support productive site visits and efficient study setup and maintenance, and adhere strictly to study protocols.
Coordinate multiple protocols, respond to and submit IRB responses, address audit findings, track adverse events (AEs) and serious adverse events (SAEs), and maintain eSource materials for assigned studies.
Take ownership of assigned studies and patients, and communicate promptly and effectively with leadership and coworkers about questions or issues requiring correction.
Learn and use company-provided technologies to improve day-to-day efficiency.
Follow applicable laws, regulations, and requirements of governing bodies.