Clinical Research Coord. I
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POST DATE 9/7/2016
END DATE 10/14/2016
Massachusetts General Hospital(MGH)
JOB DESCRIPTIONUnder supervision of the Director of the MGH Ataxia Unit, Dr. Jeremy Schmahmann, and working in collaboration with a multidisciplinary team, the incumbent will be responsible for supporting all aspects of clinical research coordination for studies in the MGH Ataxia Unit and Schmahmann Laboratory for Neuroanatomy and Cerebellar Neurobiology. The research trials may include treatment trials, biomarker trials, imaging trials, neurocognitive and motor control studies and other research. The incumbent will be responsible for generating reports and maintaining records related to the assigned research studies. The incumbent will also provide administrative support to the Director of the MGH Ataxia Unit.
Primary Responsibilities include but not limited to:
Coordinates all activities of the subjects participating in the individual research studies such as scheduling patients for research study and collecting, organizing, and documenting the patient data from the visit.
Maintains records and databases.
Assists with recruiting patients for clinical trials.
Obtains patient study data from medical records, physicians, etc.
Verifies accuracy of study forms.
Updates study forms per protocol.
Prepares data for analysis and data entry
Assists with regulatory binders and QA/QC procedures
Administers and scores questionnaires.
Provides basic explanation of study and in some cases obtains informed consent from subjects.
Performs study procedures such as phlebotomy, vital signs, and electrocardiogram.
Drafts consent forms.
Corresponds with the Institutional Review Board (IRB) for approval of protocol, notification of adverse events, continuation of study, annual reporting of studies and submission of amendments.
Assists professional staff with coordinating patient treatment according to study guidelines. For example, arranges specific blood draws, performs phlebotomy, processes fluids, records medical histories, sets up room for study specific procedures.
Able to answer questions (from study staff and patients) accordingly such as timing of tests or protocol required lab orders.
Assures investigators receive results of tests, as appropriate.
Provides, creates and maintains record keeping systems: data collection forms, consent forms, side effect sheets, drug accountability and medication logs, initialization forms, and case report forms (CRFs).
Data entry of information into study databases.
Communicate with study sponsor including scheduling/conducting monitoring visits.
Works cooperatively with study sponsor to ensure that good clinical practices are being followed.
Interacts internally with other hospital departments such as Dieteticians, Harvard Catalyst CRC, Pharmacy, and Environmental Services as needed, and externally with personnel of regulatory agencies.
Performs other administrative support duties as assigned
Accepts responsibilities for special projects as requested.
Other job related duties as required.
Conduct appropriate decorum with direct contact with a terminal patient population
Ability to multitask.
Careful attention to details
Good organization skills
Ability to follow directions
Excellent verbal and written communication skills.
Able to work with deadlines and at times a demanding environment.
Ability to interact well with others and work well, as a part of a team, with minimal supervision a must.
Education: Bachelor's degree required.
Relevant course work or project work.
An understanding of federal regulations (i.e. FDA, CFR, etc.), IRB review process, informed consent, trial design, data monitoring as well as good writing and editing skills a plus.
Prior experience working in clinical research a plus.
Office work. May travel locally to meet with patients. May have exposure to dry ice and -80degree freezers. May work at different MGH or Partners sites including 100 Cambridge Street, MGH Main Campus, Charles River Plaza, and Charlestown Navy Yard. Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.