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Position Details

Department: RSRCH-GRNT | Hemophilia Research Studies
Category: Research
Location: Phoenix
Posting #: 620065
Date Posted: 9/22/2021
Employee Type: Regular

Position Summary

This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol. This position provides administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state, regulatory agency, and specific institutional requirements.

PCH Values

  • Family-Centered care that focuses on the need of the child first and values the family as an important member of the care team
  • Excellence in clinical care, service and communication
  • Collaborative within our institution and with others who share our mission and goals
  • Leadership that set the standard for pediatric health care today and innovations of the future
  • Accountability to our patients, community and each other for providing the best in the most cost-effective way.

Position Duties

  1. Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines, which includes the following duties:
    • Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area
    • Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis
    • Maintains compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors
    • With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants
  2. Completes all tasks required by study sponsors.
    • Provides regulatory documents to sponsor in timely manner
    • Completes case report forms, data entry, and maintains source documentation for all study participants
    • Tracks and reports adverse events per sponsor and institutional guidelines
    • Coordinates research monitor visits and responds to all data queries
  3. Coordinates the process for opening new studies.
    • Obtains needed background material(s) on proposed research projects; presents findings and information to principle investigator
    • Completes feasibility questionnaires
    • Circulates the confidentiality disclosure and trial agreements to the appropriate parties
    • Creates study budgets and works with management to determine financial feasibility and resources necessary to conduct the trial
    • Assists in development of work flow procedures for study team based on specific protocol
  4. Participates in recruitment and selection of study participants. Coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
  5. Coordinates and schedules a variety of medical procedures/tests including, but not limited to, laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac and/or pulmonary function tests as needed by the study protocol(s).
  6. In conjunction with the principal investigator, research pharmacist, and other members of the research study team, provides study specific education to the participant and their family. This may include study specific procedures, diary/study log documentation, proper dosage/administration, and disease treatment.
  7. Reviews monthly financial reports, including study participant billing, expenditures, and revenue. Maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment to provide for continuous operational efficiency.
  8. Participates in a variety of professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.
  9. Performs miscellaneous job related duties as requested.

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Position Qualifications

Please review the following qualifications and specify whether you meet each of the requirements listed.
Do you meet this requirement?
1. Bachelors degree in related field Required
Do you meet this requirement?
1. One year of clinical research experience or equivalent clinical research training program approved by Director, Clinical Research Operations Required
Do you meet this requirement?
1. ACRP or SOCRA Clinical Research Certification Preferred
2. Clinical Research Training Certification Preferred
Do you meet this requirement?
Special Skills
1. Proven ability to successfully coordinate multiple studies adhering to regulatory and institutional guidelines Required
2. Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care Required
Physical Requirements & Occupational Exposure/Risk Potential
1. Physical Requirement - Feeling (sensing textures and temperatures) Occasionally
2. Physical Requirement - Fine Motor Skills (pinching, gripping, etc) Occasionally
3. Physical Requirement - Hearing Constantly
4. Physical Requirement - Pushing/pulling Occasionally
5. Physical Requirement - Reaching Occasionally
6. Physical Requirement - Sitting Frequently
7. Physical Requirement - Standing Occasionally
8. Physical Requirement - Stooping/crouching/kneeling/crawling Occasionally
9. Physical Requirement - Talking Frequently
10. Physical Requirement - Walking Frequently
11. Physical Requirement - Near Vision Frequently
12. Physical Requirement - Far Vision Frequently
13. Physical Requirement - Color Discrimination Frequently
14. Physical Requirement - Use of keyboard, mouse and/or computer equipment Frequently
15. Physical Requirement - Lift up to 35 pounds without assistance Occasionally
16. Occupational Exposure/Risk Potential - Inside office environment Applicable
17. Occupational Exposure/Risk Potential - Airborne communicable diseases Applicable
18. Occupational Exposure/Risk Potential - Bloodborne pathogens or bodily fluid Applicable
I have reviewed the qualifications, physical requirements and occupational exposure/risk potential for this position and wish to apply