Dana-Farber Cancer Institute
Clinical Research Coordinator - Breast Oncology Cohort Studies Program
Dana-Farber Cancer Institute, Boston, Massachusetts, us, 02298
Clinical Research Coordinator – Breast Oncology Cohort Studies Program
The Clinical Research Coordinator (CRC) will support the Breast Oncology Cohort Studies Program and its clinical and translational research in the areas of screening, recruitment, data collection, assurance of high-quality data, biospecimen collection and database organization. Duties include the examination, synthesis, and evaluation of medical records for screening and tracking of patients for banking and therapeutic studies, and the collection of biospecimens, including archival tissue and serial blood samples with direction and guidance from the Director and Clinical Research Managers of the overall Cohort Studies Program. This position may also screen patients for protocol eligibility, obtain informed consent, and register study participants to cohort and banking studies.
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.
Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.
Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
Coordinate and manage clinical trials, 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 work.
Qualifications
Bachelor's Degree required, with 0-1 years of related experience preferred.
Experience working in a medical or scientific research setting or comparable technology oriented business environment preferred.
Knowledge, Skills, and Abilities Required
Excellent organization and communications skills.
Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.
Must be detail oriented and have the ability to follow-through.
Ability to effectively manage time and prioritize workload.
Must practice discretion and adhere to hospital confidentiality guidelines at all times.
Must have computer skills including the use of Microsoft Office.
Equal Opportunity 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 characteristics protected by law.
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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.
Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.
Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
Coordinate and manage clinical trials, 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 work.
Qualifications
Bachelor's Degree required, with 0-1 years of related experience preferred.
Experience working in a medical or scientific research setting or comparable technology oriented business environment preferred.
Knowledge, Skills, and Abilities Required
Excellent organization and communications skills.
Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.
Must be detail oriented and have the ability to follow-through.
Ability to effectively manage time and prioritize workload.
Must practice discretion and adhere to hospital confidentiality guidelines at all times.
Must have computer skills including the use of Microsoft Office.
Equal Opportunity 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 characteristics protected by law.
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