Clinical Research Coordinator I-III

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Type of Position:
Research

Job Type:
Regular

Work Shift:

Sponsorship Available:

No

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, affirmative action institution. The University does not discriminate in its education programs or activities (including in admission and employment) on the basis of age, race, color, national origin, disability, religion, marital or parental status, protected veteran status, military service, genetic information, or sex (including pregnancy, sexual orientation, and gender identity). Federal law prohibits the University from discriminating on these bases. 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.

At UAMS we value Diversity, Equity and Inclusion. Visit our website to learn more: https://ddei.uams.edu/

For general application assistance or if you have questions about a job posting, please contact Human Resources at [email protected] .

Department:
CI tendersglobal.net Cancer Clinical Trials Operations 2

Department’s Website:

Summary of Job Duties:
The Clinical Research Coordinator is responsible for data collection and management for oncology clinical trials specific to Proton Clinical Trial Projects, which include pharmaceutical (industry) sponsored, cooperative group, and investigator initiated trials.
Must be able to organize complex projects, provide attention to detail, and communicate effectively. Works closely with Clinical Trials Office Leadership and research staff (clinical research nurses, research assistants, investigators, statisticians, regulatory specialists, finance, protocol sponsors, etc.), as well as clinical and hospital staff to manage the day-to-day operations and objectives in support of the assigned trial 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. Level III CRCs will serve as preceptors/mentors to data analysts and CRC levels I-II.

Qualifications:

Minimum Qualifications :

Level I:

• Bachelor’s degree plus 3 years general research experience, or

• Associate’s degree plus 5 years general research experience, or

• High School diploma/GED plus 7 years general research experience

Level II:

• Bachelor’s degree plus 3-5 years general research experience w/demonstrated proficiency in study planning/development, study coordination/management, and/or data collection, or

• Associate’s degree plus 7 years general research experience w/demonstrated proficiency in study planning/development, study coordination/management, and/or data collection, or

• High School diploma/GED plus 9 years general research experience w/demonstrated proficiency in study planning/development, study coordination/management, and/or data collection OR

Level III:

• Bachelor’s degree plus 5 years clinical research experience w/demonstrated proficiency in study planning/development, study coordination/management and data collection AND

• Requires CCRP, CCRC, or equivalent professional certification

Level 1: Obtain CRS certification within 2 years of hire

Level II: Obtain CRS certification within 2 years of hire

Level III: CCRP, CCRC or equivalent professional certification required at hire. CRS certification required within 2 years of hire.

1. Working knowledge of clinical biomedical and/or behavioral research

2. Working knowledge of Federal Good Clinical Practice Guidelines

3. Ability to operate independently under limited supervision, determining methods and procedures on new assignments

4. Skill and ability to communicate with others verbally or in writing to provide or obtain information and to counsel to gain a particular outcome

5. Skill and ability to provide functional guidance, leadership, and/or supervision to other staff

6. Skill and ability to work effectively in a team environment toward the achievement of common goals

7. Working knowledge of medical terminology preferred

8. Skill and ability to compile, analyze, and summarize data

9. Knowledge and skill with word processing, spreadsheet, database, and e-mail computer software (e.g., Microsoft Word, Excel, Access, Outlook)

10. Skill and ability to organize and prioritize tasks

11. Skill and ability to attend to details

12. Skill and ability to cope with work activities that may be repetitive in nature 13. Ability to maintain confidentiality of data and records

*Advancement between CRA levels contingent upon proficiency milestones.

Preferred Qualifications:

• Oncology experience

• Clinical Research experience

Additional Information:

Responsibilities:

Leadership:

• Interprets institutional, sponsor, and regulatory authority policies related to clinical trial data collection, management, and reporting to ensure departmental adherence.

• Represents the department and investigators at local, regional and national meetings; facilitates effective communication among staff, PIs and other research/clinical professionals, senior leaders of UAMS, and study sponsors.

• Serves as the general administrator and liaison for the PI, research subjects, human testing compliance, privacy/HIPAA compliance, other research and clinical professionals, and the granting or funding entity relative to the research protocol.

• 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.

• Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s).

• Prepares high-quality written documents; analyzes data and formulates conclusions.

• Participates in the development and maintenance of electronic infrastructure including protocol budget review 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. Level III CRC’s will: Assist in the development of an ongoing review of departmental/divisional standard operating procedures.

• Serves as a preceptor/mentor to clinical research staff. 

Data Collection:

• Manages the collection and transmission of samples, scheduling of clinical visits and tests, and the collection, processing, and reporting of data.

• 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 with the development of case report forms for investigator initiated trials including data point identification and case report form review.

• 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.

Additional Duties:

• Provides training for staff and investigators including site initiation visits (SIVs) and in-services to supporting departments and staff.

• Develops and implements process improvement and participates in the development of electronic infrastructure, including UAMS’ clinical trial management suite.

• Maintains appropriate professional competencies including human subject research training and continuing education.

• Performs other related duties as directed to meet the goals and objectives of the department and the institution.

• May perform other duties as assigned.

Salary Information:

Commensurate with education and experience

Required Documents to Apply:

List of three Professional References (name, email, business title), Resume

Optional Documents:

Proof of Veteran Status

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

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. 

Constant Physical Activity:
Talking

Frequent Physical Activity:
Hearing, Sitting, Talking

Occasional Physical Activity:
Sitting, Standing, Walking

Benefits Eligible:
Yes