About this Job:
General Summary of Position
Implements and coordinates research and administrative procedures for the successful management of clinical trials. Performs diverse administrative duties requiring analysis sound judgment and a high level of knowledge of study specific protocols. Enters study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.
Primary Duties and Responsibilities
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Regulatory responsibilities include the oversight and/or responsibility for the Intuitional Review Board (IRB) submissions and other related regulatory forms (e.g. scientific review) and adhering to the timelines of the study start-up process; developing informed consent documents and other documents as applicable; supporting the safety of clinical research participants; ensureing the appropriate delegation of study related tasks (i.e. Delegation of Authority).
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Explains the informed consent process and the study to the research participant (e.g. purpose duration risks/benefits) and obtains all required signatures; ensures the research participant has sufficient time and opportunity to ask the investigator medical questions; documents the informed consent process in the source document and provides the research participant with a copy of the informed consent.
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Develops an effective recruitment plan (e.g. central recruitment core); recruits research participants and discuss study protocol; educates research participants about protocol expectations and meets with research participants for each visit and maintains accessibility to discuss any questions or concerns regarding the study;
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Oversees the development of advertising materials; participates in teleconferences and/or meetings to review study progress and conduct.
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Data entry responsibilities include the completion and maintenance of case report forms and reviews data against the research participant's medical record for completeness and accuracy; addressing all queries clarifications and outstanding data queries and appropriately communicating with the sponsor and/or Contract Research Organization (CRO); completing and submitting case report forms on as close to a real time basis as possible.
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Ensures proper collection processing and shipment of biospecimens and pharmacokinetics as applicable (e.g. centrifuge freezing refrigeration) and maintains current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens;
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Assists with maintaining equipment (e.g. calibration preventive maintenance); communicates with manager investigator and sponsor regarding abnormal laboratory values; maintains Internal Air and Transportation Association (IATA) training for routine packaging labeling and transporting of biological materials.
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Study conduct responsibilities include research participant interviews and assessments at study visits as required by protocol; assessing and ensuring research participant safety through study participation; maintaining close communication with investigator;
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Attending investigator meetings as appropriate and communicating relevant information to the research team; understanding and proficiently communicating all components of research documents such as protocol investigator brochure and research instructions.
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Receives and maintains test articles from sponsor and inventory test articles; works with research pharmacist as applicable; stores test article supplies according to Food and Drug Administration (FDA) regulations and sponsor requirements; administers test article as appropriate;
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Retrieves test articles and calculates research participant compliance; maintains randomization and emergency codes of test article; documents on accountability log and research participant record (e.g. test article received used disposed).
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Ensures that non-serious and serious adverse events are properly identified documented and reported according to all applicable requirements; presents investigator with relevant information for determination of seriousness causality and intervention; acts on investigator's recommendation for adverse event intervention (e.g. stop test article call research participant re-test treat); maintains follow-up to determine resolution of adverse event.
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Understands and complies with rules for billing Medicare Medicaid and third party payors for services drugs devices tests and procedures rendered in the clinical research context;
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Responsible for reviewing understanding and accepting the billing matrix/billing plan generated by administration for research participants enrolled in clinical studies; ensures research participant stipends have been routed in a timely manner as applicable.
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Study close-out responsibilities include return or disposition of unused supplies per sponsors requirement; reconciling test article accountability; document research participants who are lost to follow-up or who have dropped out (e.g. causes contact efforts); ensuring long term storage of documents; submitting IRB closing report (i.e. termination) after sponsor has closed study site.
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Acts as a liaison with research participants investigators sponsors and healthcare professionals; prepares for site qualification study initiation monitoring and close-out visits;
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Ensures all research participant encounters are updated as appropriate and within one business day in clinical trial management system (CTMS); works effectively with multidisciplinary ancillary and inter-professional research teams; possesses a basic understanding of scientific center goals and the importance of serving our customers.
Minimal Qualifications
Education
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Bachelor's degree or an allied health or related professional degree required, or equivalent work experience
Experience
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2 years of relevant clinical research experience required
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Experience in a healthcare setting preferred
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Undergraduate and/or work experiences that demonstrates aptitude for research facilitation preferred
Knowledge Skills and Abilities
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Verbal and written communication skills.
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Basic computer skills preferred.
This position has a hiring range of : USD $59,820.00 - USD $101,836.00 /Yr.
