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Senior Coordinator, Clinical Research, Internal Medicine (Phoenix, AZ)

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Please see Special Instructions for more details.

Application: The online application should be completed in its entirety. Blank or missed information may be considered an incomplete submission. Letter of Interest: Should clearly indicate how your skills and professional employment experience meet the Minimum and the Preferred qualifications (if applicable). References: Please list 3 professional references including address, title, phone and email address.

Position Details

Position Information

Title Senior Coordinator, Clinical Research, Internal Medicine (Phoenix, AZ)
Department COM Phx Internal Medicine (0669)
Location Greater Phoenix Area
Position Summary

The Cardiovascular Institute at the College of Medicine –Phoenix, University of Arizona, is recruiting a Senior Clinical Research Coordinator. The selected individual will be responsible for all aspects of clinical trial conduct within the Cardiovascular Institute (CV) located at the Banner University Medical Center-Phoenix including regulatory and contract issues, recruitment, informed consent, study procedures, data collection and documentation, interactions with the sponsor and study close out. This individual will also be involved in the clinical research activities of the CV Institute, including the creation and population of databases and will have close interactions with faculty members leading these research activities.

The Cardiovascular Institute, located at the Banner University Medical Center-Phoenix, is currently undergoing rapid growth and the selected individual will be an important driver of this change.

The Senior Clinical Research Coordinator will be an employee of The University of Arizona College of Medicine –Phoenix and will be located in the Banner University Medical Center-Phoenix .The primary job duties are related to all research activities in the Institute. The purpose of this position is to oversee and participate in the coordination, conduct and evaluation of clinical research studies, apply knowledge of clinical research to the study population. The Senior Clinical Research Coordinator will demonstrate competence in clinical research skills, problem-solving, priority setting and serve as a resource for others for all aspects of conducting a clinical trial for complex and multi-center trials. Intermittent off-campus visits may be required.

The University of Arizona College of Medicine – Phoenix anchors the 28-acre Phoenix Biomedical Campus in the heart of the Valley of the Sun. The College inspires and trains individuals to become exemplary physicians, scientists and leaders who are life-long learners and inquisitive scholars. We embrace professionalism, innovation and collaboration to optimize health and health care for all. The Phoenix Biomedical Campus embodies the University’s priorities of engagement, partnership, innovation, and synergy in its world-class academic and research initiatives, with clinical facilities throughout Greater Phoenix. The campus also houses the UA Colleges of Public Health, Pharmacy, and Nursing, as well as Northern Arizona University’s College of Health and Human Services, the Translational Genomics Research Institute (TGen) and the International Genomics Consortium.

Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; state and optional retirement plans; access to UA recreation and cultural activities; and more!

The University of Arizona has been listed by Forbes as one of America’s Best Employers in the United States and WorldatWork and the Arizona Department of Health Services have recognized us for our innovative work-life programs. For more information about working at the University of Arizona and relocation services, please click here.

Duties & Responsibilities

Study Conduct/ Clinical Research Practice:

  • Serve as a resource for others for all aspects of conducting a clinical trial for complex and multi-center trials.
  • Develop & implement associated projects related to studies under the guidance of the principal investigator.
  • Collaborate effectively with others to ensure proper progress & completion of studies.
  • Assist other members by educating, providing resources, & consulting on difficult protocols or projects.
  • Supervises activities of subordinates, train new staff in preparation & conduct of clinical trials by providing oversight and guidance as needed to research staff.
  • Collaborate on multiple projects or studies, and support other staff or the work flow involved in research work.
  • Provide oversight and guidance to research staff for all aspects of conducting a clinical trial for complex and multi-center trials.
  • Collect and process specimens to meet study requirements.
  • Work with other divisions as needed to ensure proper handling, processing, storage and tracking of specimens per study requirements
  • Conduct complex research work and independently reviews professional literature to design appropriate research methodologies, techniques and procedures.
  • Assists faculty researchers, or may act independently, in the planning and designing of research projects, establishing priorities and recommending schedules, time tables and costs.

Regulatory Compliance and Documentation

  • Coordinate complex regulatory activities & periodic internal self-audit of records.
  • May lead staff in regulatory activities.
  • Provide oversight for the preparation, review, submission and maintenance of regulatory activities/submissions, ensure accuracy and timeliness to all collaborative parties.
  • Coordinate and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner.
  • Organize the review, correspondence and approval of human research protocols with all regulatory authorities, including study closeout.
  • Determine which research protocols or issues have additional requirements, i.e. review by additional CCHMC Divisions, regulatory agencies, or consultants, and coordinate the process to meet these requirements.
  • Act as a resource for regulatory affairs.
  • Apply federal regulations; state and local law; and CCHMC and division policies and standard operating procedures (SOPs) to promote ethical practices in research involving human participants and to ensure compliance to those regulations.
  • Ensure the documentation of regulatory activities in appropriate systems by coordinating and maintaining up-to-date and accurate written and electronic records and files.
  • Develop and maintain the regulatory binder.

Recruitment/Enrollment/Retention:

  • Prepare study staff for recruitment/enrollment for medium to large/complex complexity projects.
  • Oversee study staff performance.
  • Proactively take initiative to ensure recruitment stays on track with the project time-lines.
  • Implement successful plan to identify potential participants.
  • Engage study staff to assist in identifying and enrolling participants.
  • Proactively identify and monitor barriers to recruitment and problem-solve or innovate to overcome them.
  • Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc…) and prepare accordingly.
  • Create and maintain a detailed tracking system for participants considered for enrollment.
  • Track progress at regular intervals and report out to PI and or management.

Communication:

  • Compose clear, precise and detailed correspondence.
  • Document, organize and maintain all correspondence.
  • Oversee and follow through on questions and issues that arise during study conduct.
  • Communicate study related issues to investigators, sponsors, coordinating centers, study coordinators, clinical team, managers and other institutions in a timely fashion.
  • Develop a rapport with study participants.

Data Management:

  • Oversee data entry and validation to ensure accuracy, quality and compliance of data collection process.
  • Create case report forms (CRFs) in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry.
  • Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors.
  • Maintain and audit data, providing status and activity reports as required.
  • Maintain master database files for clinical research protocols.
  • Evaluate and resolve issues regarding contents of reports.
  • Ensure quality of data submitted from study sites and assure timely submission of data.

Education:

  • Train new staff in preparation and conduct of clinical trials.
  • Assist in developing and delivering guidelines and educational materials for investigators, research support staff and the clinical team (as applicable).
  • Complete required training. Serve as a resource to team members.
  • Assist investigators in the development of presentations, abstracts, and manuscripts.
  • Assist other members by educating, providing resources and consulting on difficult protocols or projects.
  • Additional responsibilities as assigned.
Knowledge, Skills, & Abilities
  • Knowledge of the principles, practices and techniques of research clinical skills.
  • Experience with research protocols, development, regulations.
  • Motivated to provide high quality, compliant research.
  • Skill in maintaining detailed records.
  • Desire to build new program and develop new policies.
  • Ability to work easily with a diverse team.
Minimum Qualifications
  • Eight (8) years equivalent combination of experience, training and/or education approved by Human Resources; OR
  • Bachelor’s degree in a field appropriate to the area of assignment and four years related research experience; OR,
  • Master’s degree in a field appropriate to the area of assignment AND three years related research experience.
  • Must have access to reliable transportation and possess a valid driver’s license upon hire.
Preferred Qualifications
  • Previous human subjects training (e.g., CITI certification) and four years’ experience as a research coordinator with direct recruitment and enrollment responsibilities.
  • Current Certified Clinical Research Professional (CCRP) status.
  • Previous supervisory experience.
  • Strong organization skills and significant attention to detail for data entry.
  • Self-motivated, willing and able take initiative.
  • Ability to work both independently and with a team, resolving issues with a positive outcome.
  • High level of integrity, ethics and professionalism.
  • Strong communication and computer skills.
FLSA Exempt
Full Time/Part Time Full Time
Number of Hours Worked per Week 40
Job Category Research
Benefits Eligible Yes - Full Benefits
Posted Rate of Pay $47,500 - $60,000 Annually, Depending on Experience
Type of criminal background check required: Fingerprint criminal background check (security sensitive due to job duties)

Posting Detail Information

Posting Number A22349
Number of Vacancies One
Desired Start Date
Position End Date (if temporary)
Limited to Current UA Employees No
Contact Information for Candidates

College of Medicine-Phoenix
Office of Human Resources and Business Administration
COMPHX-HRServices@email.arizona.edu

Open Date 02/02/2018
Close Date
Open Until Filled Yes
Review Begins On 02/12/2018
Special Instructions to Applicant

Application: The online application should be completed in its entirety. Blank or missed information may be considered an incomplete submission.

Letter of Interest: Should clearly indicate how your skills and professional employment experience meet the Minimum and the Preferred qualifications (if applicable).

References: Please list 3 professional references including address, title, phone and email address.

Diversity Statement

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. 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 encourage diverse candidates to apply, including people of color, women, veterans, and individuals with disabilities. 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.

Quick Link for Internal Postings http://uacareers.com/postings/26188

Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * Where did you first learn about this position?
    • Arizona Daily Star
    • Arizona Republic
    • ArizonaDiversity.com
    • Careerbuilder.com
    • Chronicle of Higher Education
    • Department of Economic Security (DES)
    • Diverse Issues in Higher Education
    • HigherEdsJobs.com
    • Hispanic Outlook in Higher Education
    • Indeed.com
    • InsideHigherEd.com
    • Jobing.Com
    • LinkedIn
    • Local Job Banks
    • Pima County One-Stop
    • Professional Conference
    • Professional journal/publication
    • Referred by UA Employee
    • Invited by Dept to Apply
    • UA Website
    • Other
  2. * Do you realize this job is located in Phoenix, Arizona?
    • Yes
    • No
  3. * Do you have a Bachelor’s degree in a field appropriate to the area of assignment and four years related research experience; OR Master’s degree in a field appropriate to the area of assignment AND three years related research experience?
    • No
    • Yes
    • I have a combination of experience, training and/or education
  4. * Do you/will you have a valid driving license with acceptable driving record at the time of hire?
    • Yes
    • No

Documents Needed to Apply

Required Documents
  1. Resume
  2. Cover Letter
Optional Documents