Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
This position will work with recruiting patients diagnosed with a Movement Disorders such as Parkinson’s Disease, Huntington’s disease, Dystonia, Ataxia and others to clinical trials consisting of treatment therapies, exercise, mobile devices and patient reported outcomes.
Please Note: Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work. Work is reviewed upon completion and only occasionally to verify technical accuracy and compliance with practice, policy, and procedures. EE informs supervisor of on-going progress and/or potentially controversial matters.
Participates in the planning & conduct of research study including participant recruitment and retention.
Reviews and obtains informed consent
Schedule study visits according to protocol
Administers tests &/or questionnaires following protocols
Extracts required medical information from medical charts
Consults with nurses & physicians to determine eligibility and study compliance
Ensures/completes all study related procedures including drawing blood & obtaining blood pressure
Orders & maintains inventory of study supplies
Ensures appropriate and timely compliance according to the local, state & federal regulatory requirements, as well as the clinical trial Sponsor
Collects, records, reviews & summarizes research data
Accurately scores overnight Polysomnography data according to study requirements and performs spectral analysis
Prepares reports for investigators and sponsors on recruitment status and other pertinent study data
Writes portions of grant applications & co-author scientific papers
Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols
May process payments for research participants per study protocol
Works with industry representatives to negotiate tentative grant funding
Coordinates reimbursements for expert panel travel, consultant pay, additional gift card orders, etc. & ensure costs remain within allotted grant budget
May provide work direction &/or train other research staff to interview/test participants
May act as a mentor in regard to education of junior coordinators
Performs other duties as assigned
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR
Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience.
Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Proficient with MS Office Suite (Word, Excel, PowerPoint, Outlook)
Communicates effectively both written & verbal
Strong organizational skills / attention to detail
Adaptable to changing priorities
High degree of professionalism
Diplomatic / uses good judgment
Team-player / collaborative
Demonstrates initiative and follow-through
Experience in a patient facing role
Previous clinical research experience
Phlebotomy experience preferred (not required); must be willing to be trained
Familiar with regulatory systems/requirements (IRBs)
Preferred Competencies: (Skills, knowledge, and abilities)
Working knowledge of medical terminology
Ability to work across multiple projects at one time in a fast paced environment with multiple investigators/stakeholders
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