Clinical Research Coordinator - Beroukhim and Ligon Labs

Dana-Farber Cancer Institute•Boston, MA

7d•Onsite

About The Position

The CRC (Clinical Research Coordinators) work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. The research teams led by Drs. Rameen Beroukhim and Keith Ligon jointly seek to hire a data coordinator who will manage large datasets for a multi-institutional consortium of scientists pursuing highly translational research. The research lies at the interface between clinical medicine and high-throughput genomics and spans multiple cancers including glioblastomas, leukemias, pancreatic cancers, and ovarian cancers. This data coordinator will interface with a wide variety of both clinical and laboratory-based researchers across the Dana-Farber Cancer Institute, MIT, the Memorial Sloan-Kettering Cancer Center, MD Anderson Cancer Center, Johns Hopkins University, and other institutions. She or he will also work closely with data scientists from all of these institutions to enable integrative analyses of these data. The data will span state-of-the-art assays including single-cell and spatial transcriptomics, proteomics, and bulk and single-cell whole-genome sequencing, long-read sequencing technologies, and clinical imaging. The data will be collected both from patients undergoing paradigm-shifting clinical trials and from laboratory-based models. The person filling this role will interact closely with and present regularly to a massive range of scientists from across the country, including clinician-scientists, basic/translational scientists, and computational biologists. The clinician-scientists include (among others) medical oncologists, radiation oncologists, surgeons, and pathologists. This is an ideal role to learn about these different careers, gain advice from a wide range of biomedical researchers, and develop a positive reputation across faculty at many of the top cancer research institutes in the country. We view this as a mentored training position, with a primary goal being the professional development of the data coordinator. Prior early-career scientists in our labs have successfully pursued a variety of subsequent career directions including obtaining MDs, PhDs, MD-PhDs, and direct entry into industry. Our laboratories recognize that achievements are often affected by the circumstances people face. If you have had to overcome significant obstacles, please highlight them so that we can take them into account Located in Boston and the surrounding communities, Dana-Farber Cancer Institute 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 related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. We are looking for a person who will think independently and take ownership of their projects and responsibilities. The work will be focused on gathering, organizing, and initiating analyses of complex datasets, and communicating results in talks and papers. A familiarity with both quantitative analysis and biomedical principles is required, as is the ability to write code. Equally important is the ability to work well with people from a wide variety of backgrounds and to communicate effectively. The work we do typically requires a full-time presence on-site.

Requirements

A familiarity with both quantitative analysis and biomedical principles is required, as is the ability to write code.
Equally important is the ability to work well with people from a wide variety of backgrounds and to communicate effectively.
The work we do typically requires a full-time presence on-site.

Responsibilities

Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries.
May prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable.
Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations.
Collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments, as needed per the requirements of the clinical trial.
Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities.
Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.
Interact with study participants as directed/required by the protocol and/or study team.
May be responsible for tissue sample collection per trial requirements.
Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.
Responsible for data entry of time and effort spent on study-specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed.
Responsible for data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.