• 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 with 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 site 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 Administrative Director 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 Administrative Director 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 Administrative Director, Principal Investigators or Executive Director.

QUALIFICATIONS:

• Bachelor’s degree in research or science field required; neurosciences preferred.
• One to two years of clinical research experience with oncology background 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:

• Self-motivated
• Careful attention to details
• Solid 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 (GCP)
• Ability to work self-reliantly with minimal supervision