Sobre este puesto de Clinical Research Data Coordinator en University of Arkansas System
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Closing Date:
Type of Position:
Researchers
Job Type:
Regular
Work Shift:
Sponsorship Available:
Institution Name:
University of Arkansas for Medical Sciences
The University of Arkansas for Medical Sciences (UAMS) has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving patient care and the lives of Arkansans.
UAMS offers amazing benefits and perks (available for benefits eligible positions only):
- Health: Medical, Dental and Vision plans available for qualifying staff and family
- Holiday, Vacation and Sick Leave
- Education discount for staff and dependents (undergraduate only)
- Retirement: Up to 10% matched contribution from UAMS
- Basic Life Insurance up to $50,000
- Career Training and Educational Opportunities
- Merchant Discounts
- Concierge prescription delivery on the main campus when using UAMS pharmacy
Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply link/button.
The University of Arkansas is an equal opportunity institution. The University does not discriminate in its education programs or activities (including in admission and employment) on the basis of any category or status protected by law, including age, race, color, national origin, disability, religion, protected veteran status, military service, genetic information, sex, sexual preference, or pregnancy. Questions or concerns about the application of Title IX, which prohibits discrimination on the basis of sex, may be sent to the University’s Title IX Coordinator and to the U.S. Department of Education Office for Civil Rights.Persons must have proof of legal authority to work in the United States on the first day of employment.
All application information is subject to public disclosure under the Arkansas Freedom of Information Act.
For general application assistance or if you have questions about a job posting, please contact Human Resources at [email protected].
Department:
CI | Coordinator Team B
Department's Website:
Summary of Job Duties:
Performs data collection and entry to support CTO oncology clinical trials which includes: pharmaceutical (industry) sponsored, cooperative group, and investigator-initiated trials. Must be able to organize complex projects, provide attention to detail, and communicate effectively. Must be able to submit data in a timely manner. Must ensure data follows the ALCOA+C (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete) good clinical research documentation practices. Works closely with Clinical Research Coordinators (CRC), CRC Manager and Clinical Research Nurses (CRNs) to manage the day-to-day operations and objectives in support of the assigned portfolio. Contributes information and ideas related to areas of responsibility as part of a cross functional team. Ensures effective and efficient workflow and adherence to quality standards for staff/program and self. Maintains a working knowledge of the Code of Federal Regulations and the code of conduct for human research. Works directly with pharmaceutical company sponsors, institutional investigators, cooperative group personnel, and research staff.
Qualifications:
Minimum Qualifications:
- Bachelor’s Degree plus 2 years of project management, data collection, data entry, or relatable experience OR Associate's degree plus 4 years' project management, data collection, data entry or relatable experience OR High School Diploma or GED plus 6 years of project management, data collection, data entry, or relatable experience
- Obtain CRS certification within 2 years of hire
Preferred Qualifications:
- Bachelor's Degree
- Clinical research experience, Oncology experience, data collection experience
Qualifications Equivalencies:
Additional Information:
Responsibilities:
- Interprets institutional, sponsor, and regulatory policies related to clinical trial data collection, management, and reporting to ensure departmental adherence.
- Facilitates effective communication among staff, PIs and other research/clinical professionals, senior leaders of UAMS, and study sponsors.
- Ensures strict adherence to all regulatory requirements such as the reporting of serious adverse events and protocol variations in the timeline required by the study sponsor and the Institutional Review Board.
- Participates in the development and maintenance of electronic infrastructure and clinical trial management suite.
- Advises the PI on administrative requirements necessary as required per protocol.
- Monitors protocol status and advises PI on requirements and deadlines.
- Abstracts source data from medical records.
- Manages the collection and transmission of data via protocol designated electronic data capture (EDC) system or paper case report forms (CRFs).
- Enters study visit information into the EDC system per timeline specified in the contract.
- Answers queries generated by the EDC or research monitor and consults with research staff as needed.
- Ensures data integrity for clinical trials and research projects by maintaining precise and detailed research records.
- Conducts follow up phone calls to research subjects and collects quality of life data in collaboration with the study team.
- Assists research staff in general administrative tasks.
- Assists departmental faculty/PI in the development, preparation, and submission of research protocols and related documentation.
- Confers with PI and support staff to secure necessary documents for proposals.
- Assists in the screening, recruitment, selection, consenting, and enrollment of subjects.
- Assists with the development, implementation, maintenance, and evaluation of quality assurance plan for conduct of clinical trials, while working closely with sponsor representatives to address and respond to monitoring and auditing reports.
- Participates in the development of electronic infrastructure and process improvement, including UAMS’ clinical trial management suite.
- Maintains appropriate professional competencies including human subject research training and continuing education.
- May perform other duties as assigned.
Salary Information:
Required Documents to Apply:
Optional Documents:
Special Instructions to Applicants:
Recruitment Contact Information:
Please contact [email protected] for any recruiting related questions.
All application materials must be uploaded to the University of Arkansas System Career Site https://uasys.wd5.myworkdayjobs.com/UASYS
Please do not send to listed recruitment contact.
Pre-employment Screening Requirements:
Annual TB Screening, Criminal Background Check, Substance Abuse Testing
This position is subject to pre-employment screening (criminal background, drug testing, and/or education verification). A criminal conviction or arrest pending adjudication alone shall not disqualify an applicant except as provided by law. Any criminal history will be evaluated in relationship to job responsibilities and business necessity. The information obtained in these reports will be used in a confidential, non-discriminatory manner consistent with state and federal law.
