Clinical Trial Manager overseeing clinical studies with a focus on Atopic Dermatitis. Ensuring compliance with ICH GCP and delivering results within contractual timelines.
About the role
- Clinical Research Coordinator supporting study activities at Hawthorne Health with onsite and remote work. Responsible for clinical trial activities, patient interaction, and data management.
Responsibilities
- Conduct and coordinate all aspects of clinical trial activities at the site.
- Perform phlebotomy on patients, following proper clinical and safety protocols.
- Recruit, screen, and enroll study participants according to inclusion/exclusion criteria.
- Schedule and conduct study visits, ensuring adherence to protocol requirements.
- Accurately collect, process, and ship biological samples per study-specific guidelines.
- Complete and maintain study documentation, including source documents, regulatory binders, and informed consent forms.
- Perform timely and accurate data entry into electronic data capture systems (EDC).
- Communicate effectively with sponsors, monitors, and other research team members.
- Ensure compliance with GCP, ICH, FDA, and IRB regulations.
- Assist in monitoring visits and audit preparation as needed.
Requirements
- Minimum of 1–2 years of experience as a Clinical Research Coordinator, in a similar environment.
- Phlebotomy certification or demonstrated competency in venipuncture (pediatric and adult required).
- Strong understanding of clinical trial operations, regulatory documentation, and data management.
- Excellent attention to detail, organization, and time management skills.
- Strong interpersonal and communication abilities with patients and clinical staff.
- Proficient in Microsoft Office and electronic data capture systems.
- CPR certification preferred.
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