REGULATORY COMPLIANCE SPECIALIST / 40 HOURS / DAY / BWH NEUROSURGERY
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POST DATE 8/24/2016
END DATE 10/14/2016
Brigham & Women's Hospital(BWH)
JOB DESCRIPTIONAPPLY GENERAL SUMMARY/OVERVIEW STATEMENT:
The Department of Neurosurgery conducts clinical research across a large range of disciplines including neuro-oncology, neuroradiology, cerebrovascular, functional brain disorders, spine and peripheral nerve, neuro trauma and image-guided neurosurgery. Our program is also affiliated with the Dana-Farber Cancer Institute for all oncology clinical trials. The clinical research program is comprised of the Chief of Neurosurgery, Dr. E. Antonio Chiocca, Clinical Research Faculty, Clinical Research Coordinators, Research Assistants, Post-doctoral fellows, and Research Trainees. Under the supervision of the Clinical Trials Project Manager, the Research Assistant II/Regulatory Coordinator will provide support to a new sponsor-initiated first-in-man oncology clinical trial recently approved by the FDA. This study will require oversight from several internal and external regulatory agencies including the Federal Drug Administration (FDA) and the National Institute of Health (NIH).
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The primary responsibility of the RAII/Regulatory coordinator will be to provide regulatory support for Sponsor-Initiated research studies. 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, investigators brochure, recruitment materials, training slides, visit checklists, Standard Operating Procedures (SOPs), guidance documents, study manuals, etc.
Liaise with investigators and disease groups on conducting clinical trials.
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 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.
Responsible for coordinating study start up procedures and addressing logistical concerns brought up by pharmacy, radiology, neuro-oncology, billing compliance and other collaborating departments.
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 project manager to address logistical concerns relating to the study drug.
Provide cross-coverage for the neurosurgery research coordinators as needed.
Assist project manager with new clinical trial submissions and regulatory management of additional trials as needed.
Position may require some on-call work.
Position may require some domestic travel.
Other tasks, projects and duties as assigned by the project manager and Principal Investigators.
Bachelors degree, which is required for this position.
Two years of clinical research experience with oncology background preferred.
Two year commitment strongly preferred for all candidates
Experience working in a healthcare setting.
Experience with Power Point, Excel and other Microsoft office programs
Experience with database management.
Available for some on-call work if required by clinical trials
Available for minimal domestic travel to other Partners Institutes
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
HOSPITAL WIDE RESPONSIBILITIES:
Works within legal, regulatory, accreditation and ethical practice standards relevant to the position and as established by BWH/Partners, follows safe practices required for the position, complies with appropriate BWH and Partners policies and procedures, fulfills any training required by BWH and/or Partners, as appropriate, brings potential matters of non-compliance to the attention of the supervisor or other appropriate hospital staff.
Brigham and Womens Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements, genetic information, military service, or other protected status.
Brigham and Womens Hospital I CARE Standards
The I CARE Standards guide me in my interactions with patients, family members, visitors, colleagues, and neighbors in my workplace and surrounding community to optimize the Brigham experience and help fulfill my role in our mission of providing seamless, high quality patient and family centered care.
C. I will Communicate my commitment to high quality performance
A. I will Appear and act as a professional
R. I will Respect all individuals
E. I will Extend myself