Maryland Oncology
Remote Regulatory Affairs Coordinator II - All TxO Locations
PayCompetitive
LocationDallas/Texas
Employment typeFull-Time
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Job Description
- Req#: 32000
Employer Industry: Oncology Healthcare
Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Supportive and collaborative work environment
- Chance to make a positive impact on cancer care and patient outcomes
- Involvement in cutting-edge research and clinical trials
- Work remotely, providing flexibility in your work-life balance
What to Expect (Job Responsibilities):
- Assist with critical document collection and maintenance to facilitate the timely opening of trials and ensure audit-readiness
- Communicate and collaborate with central operations to identify and resolve regulatory issues
- Maintain protocol regulatory documents in compliance with local standard operating procedures
- Assist with the preparation of informed consent documents and regulatory packets for sponsor and IRB submissions
- Monitor and report serious adverse events (SAEs) to sponsors and IRBs
What is Required (Qualifications):
- High School Diploma required
- Minimum of three (3) years of experience in clinical research, regulatory affairs, and/or an oncology-related field required
- Experience in Microsoft Office
- Exceptional communication skills and strong ability to multi-task
- Excellent time management skills
How to Stand Out (Preferred Qualifications):
- Associate's degree in a clinical or scientific-related discipline preferred
- Experience working with Sponsor Monitor representatives preferred
- Background in clinical research, regulatory affairs, and/or an oncology-related field is preferred
#OncologyHealthcare #ClinicalResearch #RemoteWork #CareerGrowth #PatientCare
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