Overview:
The Research Coordinator will work with a research team on several federally-funded studies designed to evaluate the behavioral and physiological effects of nicotine and tobacco use in human research participants, as well as other studies as needed. Responsibilities include:
Oversees, organizes, and executes daily activities for research studies including the recruitment, screening, and scheduling of study participants.
Administers research questionnaires and assessments.
Performs blood and urine specimen collection and processing.
Performs data collection, analysis and interpretation in order to ensure data integrity, quality control and protocol compliance. Manages data and tracking of participants.
Reviews and comprehends each research protocol including study procedures and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
Coordinates with PI to help ensure that clinical research and related activities are performed consistently with the organization's standard procedures and applicable regulations.
Utilizes established physiological, psychological, socio-behavioral and/or neurobiological research methods, techniques and procedures in performing research.
Ensures proper compliance with Institutional Review Board (IRB) and other regulatory agencies to include: preparation and maintenance of regulatory binder information and all IRB correspondence with regards to study submissions.
Maintains research records in a confidential manner according to organizational policies, sponsor confidentiality agreements, human subjects protection regulations, and other applicable regulations.
Maintains research participant screening logs and protocol deviation logs.
Assists with study materials such as informed consent documents, recruitment materials, case report forms, test article logs, and enrollment logs.
Orders and maintains research supplies, compiles research charts, prepares source documents, and related duties.
Organizes data for the preparation of project progress reporting and for proposals for new funding.
Contributes to the design of current and upcoming research projects using scientific approaches and methodologies.
Assists in the planning of data presentations, preparation of papers for publication, presentations and conferences and in the writing of project reports, articles and other documents. Provides analytic and narrative input for abstracts, manuscripts and presentations.
Performs other related duties as assigned.
Qualifications:
Requires a bachelor's degree in a scientific discipline or related field and a minimum of 2 years of directly-related expertise in human/clinical research studies; or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
The Research Coordinator position requires specialized knowledge and comprehensive research, administrative, organizational, and operational skills, along with experience in a clinical research setting.
Must have a sound and fundamental knowledge of federal and state laws and regulations pertaining to human subject research.
Requires a professional demeanor, strong analytical, time management, and organizational skills, meticulous attention to detail, and excellent verbal/written communication and interpersonal skills.
Must have demonstrated success in working independently as well as a part of a team, and the ability to work against firm deadlines.
Must have professional-level computer skills and advanced experience with Microsoft Office and Google systems and the ability to learn department-specific computer systems as needed.
Preferred/Additional Qualifications :
Knowledge of FDA and OHRP regulations and guidance as well as training in research ethics, HIPAA, and GCP are preferred.
Experience with REDCap is preferred
Expertise in scientific protocol and consent form writing/editing, as well as working with IRBs for protocol management across the study lifecycle are preferred.
CCRP, CCRC, or similar clinical research certification is strongly preferred. If applicant does not have a current clinical research certification, applicant must meet requirements to apply for certification upon hire, and obtain the certification (at company's cost) within a year.
Physical Requirements:
Work is performed in a dry laboratory environment. Will operate standard office equipment and will frequently stand, walk, sit, perform desk-based computer tasks, use a telephone, perform repetitive motions and occasionally lift objects that weigh up to 20 pounds. May interact with research participants.
The above is intended to describe the general requirements for the position and should not be interpreted as an exhaustive statement of physical requirements. The Institute will provide reasonable accommodation to any employee with a disability who requires an accommodation to perform the essential functions of the position.
Salary:
Salary is commensurate with experience.
EEO, including disability/vets
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