The following responsibilities represent Research Conduct/Study Management
1) Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.
2) Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
3) Organizes and actively participates in site visits from sponsors and other relevant study meetings.
4) Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.
The following responsibilities represent Data Management.
5) Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.
6) Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.
7) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.
1) Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
2) Ability to communicate with tact and diplomacy.
3) Strong organizational skills.
4) Strong communication skills (verbal and written).
5) Excellent interpersonal skills.
6) Strong data management skills and attention to detail.
7) Knowledge of Microsoft Word, Excel and Adobe Acrobat.
8) Ability to read and understand complex documents (e.g., clinical trials).
9) Ability to handle competing demands with diplomacy and enthusiasm.
10) Ability to absorb large amounts of information quickly.
11) Adaptability to changing working situations and work assignments.
12) Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.
13) Knowledge of medical terminology / environment.
14) Understanding of the federal research regulations and the ability to identify the federal research organizationsâ™ role in regulating human research participation.
1) Bachelorâ™s degree
1) 1 year of clinical research experience or relevant experience
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
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