Unit-specific Responsibilities 1) The Clinical Research Coordinator (CRC) is a specialized researcher working the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager.
2) While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
3) By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
4) Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
5) Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
6) Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
7) Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
8) Organizes and attends site visits from sponsors and other relevant study meetings.
9) Conduct literature reviews and assist with the preparation of reports, presentations, and manuscripts.
10) Draft data collection instruments and develop other study documents and materials.
11) Collect, enter, manage, and analyze data under the direction of the Principal Investigator and research team.
12) Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations.
13) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
14) Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, and study related communication.
15) Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions.
16) Understand the federal research regulations and identify the federal research organizationsâ™ role in regulating human research participation.
17) May prepare and maintain protocol submissions and revisions.
18) Manage websites and social media for the Center for Diabetes Translation Research and the Center for Chronic Disease Research and Policy at UCM.
19) Provide other research and general administrative support as assigned.
1) Ability to communicate with tact and diplomacy.
2) Strong organizational skills.
3) Strong communication skills (verbal and written).
4) interpersonal skills.
5) Strong data management skills and attention to detail.
6) Knowledge of Microsoft Word, Excel and PowerPoint.
7) Ability to read and understand complex documents (e.g., clinical trials).
8) Ability to handle competing demands with diplomacy and enthusiasm.
9) Ability to work independently and as part of a team.
10) Problem-solving skills and initiative.
1) Bachelor's degree
1)One year of research experience or relevant experience
2)Knowledge of medical terminology/environment Â
2) Cover letter
Note: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
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