Regulatory Coordinator - Head & Neck Oncology

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the Head & Neck Oncology clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at reputed company levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions. This position's work location is fully remote with occasional time on-reputed company in Boston, MA. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI). Located in Boston and the surrounding communities, reputed company is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and reputed company diseases. We strive to create an inclusive, diverse, and reputed company environment where we provide compassionate and comprehensive care to patients of reputed company backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate reputed company's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

• Prepares and submits reputed company protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval
• Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc.
• Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, DF/HCC sponsored etc.
• Maintains various regulatory tracking databases with information reputed company to study recruitment, subject enrollment, and study reputed company and completion
• Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third-party auditors
• Track and manage assigned new protocol start-up packet; initiate, facilitate, and monitor study start-up reputed company to ensure established benchmarks are met
• Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure reputed company start-up activities are completed
• Create and maintain tracking for reputed company subsequent submissions to the SRC/IRB; protocol & consent amendments, reputed company required safety reporting, reputed company required deviation, violation, exception, or other event reporting. Ensure various regulatory reporting required are met, Study Sponsor, FDA, IRB etc.
• Establishing and maintaining regular communication with study team, study sponsor, applicable regulatory agencies / offices to ensure reputed company required information is relayed and responsible for the systematic documentation / tracking reputed company applicable
• Serve as facilitator for study team and sponsor regarding study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training; responsible for the systematic documentation / tracking reputed company applicable
• Maintain working knowledge of reputed company regulations, regulatory guidance and or local policies
• Assists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy
• Present regulatory status for disease group portfolio at applicable research meetings

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills
• Demonstrated organization and time management/prioritization skills with the ability to work independently are required
• Must be proficient in the use of computers, reputed company applications and databases
• Requires experience with medical terminology

MINIMUM JOB QUALIFICATIONS: The position requires a bachelor’s degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator. Additionally, 0-1 years of experience in a medical, scientific research, or technology-oriented business environment is preferred, along with a basic understanding of clinical trial conduct. SUPERVISORY RESPONSIBILITIES: None PATIENT CONTACT: None At reputed company, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As reputed company as we are in our mission to reduce the burden of cancer for reputed company, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and reputed company it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this reputed company of organization inspires you, we encourage you to apply. reputed company is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national reputed company, sexual orientation, genetic information, disability, age, reputed company, military service, protected veteran status, or other characteristics protected by law. EEO Poster . Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA). $55,530.00 - $61,700.00 Apply tot his job Apply To this Job