- Dana-Farber Cancer Institute
- $58,070.00 -91,730.00/year*
471 Walnut St
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.The ETCTN Regulatory Coordinator (RC) works under the direction of the ETCTN Grant holder(s), or directly for the DFCI Clinical Trials Office to complete the regulatory requirements and administrative requirements of the ETCTN program grant. The ETCTN RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and Dana-Farber/Harvard Cancer Center (DF/HCC) policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, NCI-CTEP, and various clinical trials experts. Works interactively with the DF/HCC Office for Human Research Studies (OHRS), DF/HCC Office of Data Quality (ODQ), and representatives from clinical trials offices at the various DF/HCC institutions.
* Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for review and approval.
* Prepares and submits various regulatory documentation, that may include Serious Adverse Event reports, to the appropriate regulatory agencies.
* Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor and DF/HCC requirements.
* Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.
* Assists in the preparation and coordination of assigned study monitoring and auditing visits.
Clinical Trial Management
* Tracks and manages assigned new protocol start-up packet; initiate, facilitate and monitor study start-up progress to ensure established benchmarks are met.
* Communicates and collaborates with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed
* Creates and maintains tracking for all subsequent submissions to the SRC / IRB; protocol & consent amendments, all required safety reporting. Ensure various regulatory reporting required are met.
Key Stakeholder Interfacing
* Establishes and maintains regular communication with study team, study sponsor, applicable regulatory agencies / offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when applicable.
* Serves as facilitator for study team and sponsor with regard to study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training; responsible for the systematic documentation / tracking when applicable.
Leadership and Professionalism
* Maintains working knowledge of ETCTN portfolio, current regulations, regulatory guidance and local policies .
* Assists study team with regulatory based training and implementation of new or revised regulation, guidance and local policy.
* Presents regulatory status for ETCTN portfolio at applicable research meetings.
* Bachelor's degree (BA, BS) in life sciences, nursing, or other related discipline is required; 1-3 years of direct regulatory experience required.
* Must have knowledge of IRB guidelines.
* Previous experience with clinical trials and/or research coordination 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, Microsoft applications and databases.
* Requires experience with medical terminology.
Dana-Farber Cancer Institute 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 origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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