Dana-Farber Cancer Institute
Regulatory Coordinator - Oncology Research
Dana-Farber Cancer Institute, Brookline, Massachusetts, us, 02445
Join the Dana-Farber Cancer Institute team as a
Regulatory Coordinator - Oncology Research . In this vital role, you will work under the guidance of Principal Investigators and the Regulatory Operations Manager to ensure smooth regulatory processes for gynecologic oncology clinical trials. Your key responsibilities will include: Coordinating protocol submissions, preparing and submitting regulatory documents, and maintaining thorough records to meet compliance standards with DFCI and DF/HCC policies as well as federal regulations. Working collaboratively with various stakeholders, including faculty, study team members, industry representatives, and regulatory agencies to facilitate the regulatory requirements of clinical research projects. Preparing and submitting all necessary applications and amendments to the SRC and IRB for approval, including informed consent documents. Tracking and managing study progress to meet predetermined benchmarks and ensuring timely communication with the key stakeholders. Assisting with monitoring and auditing visits, preparing essential documentation for compliance, safety reporting, and regulatory submission. Qualifications: A Bachelor's Degree is required. Experience in medical or scientific research settings is preferred. Knowledge of regulatory compliance and clinical trial processes is beneficial. Excellent written and verbal communication skills, along with strong organizational and time management abilities. Proficient in Microsoft applications and comfortable with medical terminology. At Dana-Farber Cancer Institute, we are committed to creating an inclusive and diverse environment that fosters equitable treatment for all individuals. If you share our passion for advancing cancer research and care, we encourage you to apply. This position is located in Boston, MA, and represents a full-time opportunity with a salary range of $70,000.00 - $80,000.00. Join us in our mission to conquer cancer and make a difference in the lives of patients.
Regulatory Coordinator - Oncology Research . In this vital role, you will work under the guidance of Principal Investigators and the Regulatory Operations Manager to ensure smooth regulatory processes for gynecologic oncology clinical trials. Your key responsibilities will include: Coordinating protocol submissions, preparing and submitting regulatory documents, and maintaining thorough records to meet compliance standards with DFCI and DF/HCC policies as well as federal regulations. Working collaboratively with various stakeholders, including faculty, study team members, industry representatives, and regulatory agencies to facilitate the regulatory requirements of clinical research projects. Preparing and submitting all necessary applications and amendments to the SRC and IRB for approval, including informed consent documents. Tracking and managing study progress to meet predetermined benchmarks and ensuring timely communication with the key stakeholders. Assisting with monitoring and auditing visits, preparing essential documentation for compliance, safety reporting, and regulatory submission. Qualifications: A Bachelor's Degree is required. Experience in medical or scientific research settings is preferred. Knowledge of regulatory compliance and clinical trial processes is beneficial. Excellent written and verbal communication skills, along with strong organizational and time management abilities. Proficient in Microsoft applications and comfortable with medical terminology. At Dana-Farber Cancer Institute, we are committed to creating an inclusive and diverse environment that fosters equitable treatment for all individuals. If you share our passion for advancing cancer research and care, we encourage you to apply. This position is located in Boston, MA, and represents a full-time opportunity with a salary range of $70,000.00 - $80,000.00. Join us in our mission to conquer cancer and make a difference in the lives of patients.