Remote Study Coordinator- 260419
Company: Medix™ Agency
- Location: United States
- Work mode: Remote
- Seniority: Mid level
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Job Title: Remote Clinical Study Coordinator – Oncology (Hematology OR Head, Neck & Lung)
Location: 100% Remote (Candidates can be located anywhere, but must be able to work Monday–Friday on a Mountain Time Zone schedule)
Schedule/Shift: Full-Time, M-F
Position Overview: We are currently seeking a dedicated and experienced Clinical Study Coordinator to join our remote oncology research team. In this role, you will plan the execution and monitor the completion of intense and highly complex assigned clinical research protocols. This includes supporting other research teams, monitoring adherence to the clinical protocol, and preparing reports on the data.
We are hiring for two specific focus areas within Oncology:
- Hematology: (Please note: Prior Hematology experience is required for this focus area).
- Head, Neck & Lung.
Responsibilities:
- Work closely with the physician principal investigator, clinical trial sponsor, and internal and external study teams for study operation.
- Assists in the execution of highly complex trials for the research team. Trials assigned will involve complex protocol management and assisting the data management, clinical, and regulatory research teams.
- Attend sponsor calls and participate in sponsor meetings as assigned.
- Assist with the training of new Study Coordinators and Data Coordinators.
- Initiate improvements, tools, processes, and forms to enhance efficiency and quality of work within the research department.
- Plan and track all assigned clinical activity in the lifecycle phases of startup, interim, and close-out.
- Update clinical teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, and central and local laboratory assessments.
- Create study-specific tools for source documentation, as well as checklists and clinic information documents.
- Ensure study-specific tools are updated with any amendment(s) or study changes.
- Participate as needed in monitor visits for each assigned trial at each monitoring visit.
- Assist with reviews of trial data for responses to queries.
- Provide required study metrics to leadership.
- Assist in physician oversight by providing updates on protocol issues.
- Assist with sponsor and FDA audit preparation.
- Assist with reviews and responses to monitoring and auditing findings.
- Adhere to professional standards and SOPs established for clinical research.
Required Qualifications & Skills:
- Education: Associate’s degree required.
- Experience: Minimum of 3+ years of research experience working on interventional trials, 1+ year of prior oncology experience, and If applying for the Hematology focus: Previous Hematology experience is required.
- Availability: Must be able to work a consistent full-time schedule aligned with the Mountain Time Zone.
