Clinical Research Coordinator II - Pediatric Outcomes | Dana-Farber Cancer Institute Job at Dana-Farber Cancer Institute, Brookline, MA

alhLdEJOOGNZU01SUnNaREEvdFVGdmJNRWc9PQ==
  • Dana-Farber Cancer Institute
  • Brookline, MA

Job Description

This position works within the Bona Lab in the Pediatric Outcomes research program. The Bona Lab?s research portfolio focuses on improving childhood cancer outcomes by systematically considering social determinants of health as risk factors in the clinical trial setting and identifying potential targets for intervention.

The Clincal Research Coordinator (CRC) will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Maintains regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants to clinical trials.

This is a remote per diem role and will be working 10 hours per week. Previous CRC experience is required. * 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, 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.

  • 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.
  • Coordination and management of 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.
  • Orients and assists in training new staff.

  • Bachelor?s Degree and 1-3 years of equivalent experience required.
  • Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.

Competencies :

  • Demonstrates understanding of CRF completion, including timely and accurate transcription of study data
  • Shows an understanding in setting up, coordinating and managing clinical research studies
  • Shows an understanding of ICH/GCP and Federal Regulatory requirements
  • Shows an understanding of DF/HCC SOPs
  • Shows an understanding of the roles and responsibilities of other key departments within clinical research (ex. OHRS, QACT, CTO etc.)
  • Proficient in understanding of phases of clinical trials
  • Ability to coordinate PI initiated studies
  • Is competent and autonomous with minimal assistance and supervision.

Knowledge, Skills, and Abilities Required:

  • Excellent organization and communications skills required.
  • Strong interpersonal skills - ability to effectively interact with all levels of staff and externals 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

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.  As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.  Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

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.

About Dana-Farber Cancer Institute

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 under-served members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Connections working at Dana-Farber Cancer Institute

Job Tags

Similar Jobs

Newport News Sheriff's Office

Deputy Sheriff Job at Newport News Sheriff's Office

 ...general district, circuit, juvenile, civil and domestic relations courts; serves civil processes (legal documents); transports inmates;...  ..., court operations, as well as police, sheriff, and local and federal task force operations. WORK BEHAVIOR STATEMENTS/JOB... 

Screen Rant

Network TV Features Journalist Job at Screen Rant

Please note: This is a paid freelance remote position. We are currently only accepting applicants located in the United States, the United Kingdom, and Canada. Screen Rant is the #1 entertainment website on the web and publishes up-to-the-minute news on blockbuster ...

Black River Falls Public Library

Library Assistant Job at Black River Falls Public Library

 ...description Black River Falls Public Library - Library Assistant Job Description Nature of Work :...  ...assignment deadlines by utilizing effective time management skills and communicating...  ...is beneficial. This position is part-time and will include day, evening and... 

The Specialty Companies

Production Assistant Job at The Specialty Companies

 ...printing as well as bindery? We would love to talk to you about bringing your exceptional skills to work for us as our Printing Production Assistant. We are fast paced and work hard but also know how to have a good laugh and work as a team. Responsibilities:- Assist in... 

GD Land Systems

Stryker Combat Vehicle Mechanic Ft. Riley Job at GD Land Systems

 ...Responsibilities for this Position Position Title: Stryker Combat Vehicle Mechanic Ft. Riley Location: Junction City (Ft Riley), KS, United States Category: Skilled Trades/Mechanics/Technicians Job Type: Full-Time Country: United States State:...