***This position is best for those students graduating in 2021 or any alumni that have a long-term career interest in the public health, healthcare management, and/or prospective clinical interests (i.e. MD, NP, PA, etc. who need additional experience in the healthcare field prior to submitting applications for such degrees). The Department of Neurosurgery prides itself on providing all interested staff throughout the Department with opportunities to observe and participate in educational events and research endeavors in the individual candidate’s area of focus or interest. These opportunities are not noted in the job description, but offered to all personnel***
***Those with clinical research experience will be considered for CRC II or Senior Research Assistant level***
The BWH Department of Neurosurgery currently conducts a broad range of industry and federally sponsored (drug/device/procedure) clinical trials that span the breadth of the Neurosurgery practice, including spine trials, neuro-oncology trials, and cerebrovascular trials. Our program is also affiliated with the Dana-Farber Cancer Institute for shared oncology clinical trials. We are currently seeking an eager individual to join our clinical research team as a Clinical Research Coordinator I (CRC). Under the supervision of the Research Administrator, the CRC provides support to clinical trials within the Department of Neurosurgery. Primary duties and responsibilities for assigned studies include:
- Assist in the development and writing of the clinical trial protocol and other study specific documents including but not limited to: consent forms, case report forms, investigator’s brochure, recruitment materials, training slides, visit checklists, Standard Operating Procedures (SOPs), guidance documents, study manuals, etc.
- Communicate with Clinical Trial Investigators to operationalize clinical trials.
- Screen patients for eligibility criteria to participate in clinical trials. Interact patients and patient families to explain clinical trial protocols for possible participation.
- Prepare and manage regulatory applications to federal and local agencies (FDA, NIH, IRB, etc.) and the related approval process.
- Monitor trial progress throughout its duration and advise/train research coordinators recruiting to the trial on protocol specifics.
- Verify that data entered on the case report form and entered into the electronic data capture is consistent with patient clinical notes and other source documentation (source data verification).
- Act as a regulatory resource by maintaining regular contact with investigators and study teams during the course of studies to ensure that compliance is maintained in collaboration with the Research Administrator and the Regulatory Affairs Coordinator.
- Responsible for coordinating study start up procedures and addressing logistical concerns brought up by pharmacy, radiology, neuro-oncology, billing compliance and other collaborating departments.
- Responsible for entering data and maintaining the study database per the expectations of the PI and the sponsor.
- Prepare reports as required regarding the status of ongoing studies and make necessary recommendations for contingency planning.
- Manage pharmacy documentation and arrange for ongoing stability testing of study drug with third party entities. Work with the Research Administrator and Research Nurse to address logistical concerns relating to the study drug.
- Provide cross-coverage for other neurosurgery research coordinators as needed.
- Assist with new clinical trial submissions and regulatory management of additional trials as needed.
- Other tasks, projects and duties as assigned by the Research Administrator, Principal Investigators or Executive Director.
The minimum qualifications for this position are the following:
- Bachelor’s degree in research or science field required; neurosciences preferred.
- Experience working in a healthcare setting preferred.
- Experience with Power Point, Excel and other Microsoft office programs.
- Experience with database management.
- Two-year commitment strongly preferred for all candidates
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
- Careful attention to details
- Strong organizational skills
- Strong communication skills
- High degree of computer literacy
- Ability to work independently and as a team member
- Strong critical thinking skills and ability to independently resolve problems
- Working knowledge of data management software and procedures
- Strong understanding of Good Clinical Practice
- Ability to work independently under minimal supervision
Brigham and Women’s Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.