Clinical Research Coordinator 2

Department
 

BSD MED - Center for Health and the Social Sciences - Oral Health

About the Department
 

Center for Health and the Social Sciences (CHeSS) has designed a new research project ‘A Randomized Control Trial on the Effects of No-Fee Basic Dental Care on Systemic Health of Older Adults’. The clinical trial launched in the Summer 2019. By doing this study, we hope to learn about how offering no-fee dental care to older adults for a period of 5 years who do not have coverage for dental care and are not receiving regular dental cleanings affects their quality of life, health and health care costs.

Job Summary
 

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher working with the Principal Investigator (PI) Dr. David Meltzer, Co-Investigator(s) and other study personnel, and under the limited direction of departmental, clinical research director/manager and/or the Office of Clinical Research (OCR).With limited supervision and/or guidance, the CRC2 works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or the OCR to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study. Provide technical and administrative support for the Program in Oral Health, Systemic Health, Well-Being and the Social Sciences Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

Responsibilities

• Recruit, interview and collect intraoral images of potential study patients with guidance from PI and other clinical research staff.

• 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.

• 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.

• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.

• Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.

• Performs assessments at visits and monitors for adverse events.

• Organizes and attends site visits from sponsors and other relevant study meetings.

• Manage day-to-day functioning of the study dental clinic including managing equipment sterilization, inventory of supplies and instruments and other clinic related activities.

• Manage day-to-day activities of the clinical study and research assistants.

• Provide day-to-day administrative and clinic support to dental team including dental hygienists and dentists who are a part of the Oral Health study clinic.

• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.

• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.

• Managing identification, collection, labeling, filing of all images and integrating with other respondent information.

• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), dental clinic documentation, and study related communication.

• 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.

• Understand the federal research regulations and identify the federal research organizations’ role in regulating human research participation.

• May prepare and maintain protocol submissions and revisions.

• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• Performs other related work as needed.

Minimum Qualifications
 

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through < 2 years of wor