Pima Clinical Research Coordinator Internship (Temporary) (Multiple Positions) - Cancer Center
Posting Number: req9894
Department: Cancer Center Division
Location: UAHS - Tucson
Address: University of Arizona Health Sciences, Tucson, AZ USA
Position HighlightsThe Research Data Support Specialist I position is being utilized to fulfill the requirements of Pima CRC Internship and to assist the Arizona Cancer Center Clinical Trials Office (CTO) with data management and regulatory needs. The intern is responsible for coordinating the data management and regulatory components of research protocols. They adhere to the specific timelines for documentation submission while adhering to good clinical practice and the code of federal regulations. The intern will assist in collecting and entering study data into one of numerous clinical trial data bases and prepare and/or coordinate IRB submission of amendments, revisions, IND safety reports and progress reports for approval. The intern will work closely with Research Data Coordinators, Clinical Research Coordinators, RNs, Regulatory staff, clinic staff, and physicians to confirm that all data is collected and entered in accordance to the clinical trial requirements. The intern will develop a knowledge base of the disease areas assigned and learn the differences between the clinical trial phases and Investigator Initiated, sponsored and cooperative group studies of varying complexities. The intern will work to complete their Pima Community College CRC program internship.
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Duties & Responsibilities
- Understand the role of a Clinical Research Coordinator and complete the PIMA Community College CRC Internship.
- Learn how to apply Good Clinical Practice (GCP) and the Code of Federal Regulations to coordinate the data management requirements of IRB approved clinical trials protocols.
- Confirm the data requirements for all assigned IRB approved clinical trials protocols is met.
- Learn where to find appropriate documentation and submit data.
- Observe and/or participate in trainings and staff meetings.
- Attend and participate intraining from the Clinical Trials Office, University of Arizona, Banner and Sponsors to stay informed of processes and procedures.
- Observe Site Evaluation Visits (SEV), Site Initiation Visits (SIV), monitoring visits and possibly audits for Investigator Initiated trials (IITs), sponsored studies and cooperative group trials.
- Perform Data Management Coordination and/or Regulatory Coordination.
- Following ALCOA guidelines, all data collected must be attributable, legible, contemporaneous, original and accurate and stay in compliance with Good Clinical Practice.
- Coordinators collect, organize and enter data into different data management systems including our local clinical trials management system, the electronic medical record system and specific electronic data capture systems.
- Prepare and/or coordinate IRB submission of amendments, revisions, IND safety reports, and progress reports for approval for assigned disease area studies.
- Prepare/coordinate and maintain all regulatory documentation required by FDA and sponsor.
- Perform Quality Assurance.
- Learn to ensure that all study documentation and source data is accurate and up to date.
- Assist in archiving procedures, if necessary.
- Learn to follow up on action items and queries.
- Follow up with research patients as required.
- Learn to read and follow clinical trial protocol calendars and confirm time points are met.
- Maintain proper communication within the department.
- Constant communication is required between clinic staff, research RNs, Pharmacokinetic team member, study monitors, and physicians.
- Learn to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting and protocol deviations or violations.
- Other duties as assigned.
Knowledge, Skills, & Abilities:
- Demonstrated strong interpersonal, communication, and problem-solving skills.
- Excellent organizational skills.
- Ability to navigateelectronic databases.
- Detail oriented.
- Proficient in typing and transcription.
- High school diploma or equivalent, or equivalent learning attained through experience may be required.
* Working towards completing a Pima Community College CRC Associates Degree.
Full Time/Part Time: Full Time
Number of Hours Worked per Week: 40
Job FTE: 1.0
Work Calendar: Fiscal
Job Category: Research
Benefits Eligible: To be Determined
Rate of Pay: $13.50 - $16.66
Compensation Type: hourly rate
Career Stream and Level
Research & Data Analysis
Type of criminal background check required: Name-based criminal background check (non-security sensitive)
Number of Vacancies: 4
Expected End Date: 8/30/2022
Contact Information for Candidates
Alaina Krone | firstname.lastname@example.org
Open Until Filled: Yes
Documents Needed to Apply: Resume and Cover Letter
Special Instructions to Applicant
Application: The online application should be completed in its entirety.
At the University of Arizona, we value our inclusive climate because we know that diversity in experiences and perspectives is vital to advancing innovation, critical thinking, solving complex problems, and creating an inclusive academic community. As an Hispanic-serving institution, we translate these values into action by seeking individuals who have experience and expertise working with diverse students, colleagues, and constituencies. Because we seek a workforce with a wide range of perspectives and experiences, we provide equal employment opportunities to applicants and employees without regard to race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or genetic information. As an Employer of National Service, we also welcome alumni of AmeriCorps, Peace Corps, and other national service programs and others who will help us advance our Inclusive Excellence initiative aimed at creating a university that values student, staff and faculty engagement in addressing issues of diversity and inclusiveness.