Respiratory Therapist Clinical Research Coord - Critical Care

SUMMARY

The Respiratory Therapist Clinical Research Coordinator is responsible for multiple research studies simultaneously, as a professional licensed liaison with the investigators, treating teams, pharmacy, laboratories, IRB's, Sponsors and sponsor agencies. Responsible for records and managing all phase of study protocols by sponsoring agencies ensuring compliance. Directly assists the Principal Investigator to supports the achievements of the research program and the study aims and objectives. 30% of time will be Respiratory Therapy duties and 70% of time will be Research Coordinator duties.

SHIFT

Critical Care Research Team

Rotating Weekend schedule

Opt-in for holiday coverage

8:30 a.m. - 4:30 p.m.

ESSENTIAL FUNCTIONS

An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions which the employee may be expected to perform.

1. Uses respiratory therapist professional knowledge to build orders in the EMR, (EPIC - Department specific).
2. Makes medical assessments of study participants, within the scope of their Colorado Respiratory Therapy license. Educates Clinical research coordinators (CRC's), and pts and families on research protocols
3. Submits and/or provides assistance to CRCs with protocol submissions to the IRB(s) for review and approval throughout startup, continuing review, amendments and correspondence process by providing necessary medical/respiratory therapist components. Submits and/or provides assistance to CRCs with preparation of PI applications to the FDA for eIND/IND/IDE approval.
4. Under the direction of the principal investigator assists with developing or develops protocols, protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs).
5. Screens, schedules, and/or consents participants for clinical research programs and/or studies. Maintains subject level documentation and prepares documents, equipment and/or supplies.
6. Prepares for and takes part in site initiation, monitoring, closeout visits, and document storage activities. Conducts and documents visits and testing/interviews per all regulatory and organizational protocols. Collects, prepares, processes, ships and maintains inventory of research specimens. Prepares study records for FDA, and sponsor audits.
7. Collects, prepares and/or processes Adverse Event (AE) information per protocol and provides input for AE reports. Complete and submit AE reports, per institution and sponsor-specific reporting requirements. Maintains or collaborates to maintain appropriate documentation.
8. Maintains compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. May assist with the design of safeguards to ensure ethical conduct and to protect vulnerable populations.

9. Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Recognize and report vulnerabilities related to security of physical and electronic data. Adheres to and participates in the development and assessment of quality assurance. Assists with recognizing trends related to data quality and escalates as appropriate.

10. Utilizes electronic data capture systems, technologies and software necessary for clinical research program and/or study operations. Enters data and completes required forms accurately and per protocol. Assists with the development of data collection documents and instruments. Identifies issues related to data capture, collection or management and recommends solutions.
11. Assists with management of Investigational Products (IP). Utilizes required system for handling, dispensing and documenting IP for sponsored protocols. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.
12. Participates in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing.

MINIMUM QUALIFICATIONS

Education: Associate's degree in Respiratory Therapy or Respiratory Care is required at the time of hire

Experience: Four years of experience providing respiratory care

Equivalency: None

Certification(s):

• Certification as a Registered Respiratory Therapist (RRT) by the National Board of Respiratory Care

• BLS- American Heart Association for Healthcare Provider OR American Red Cross for the Professional Rescuer/CPR;

• Pediatric Advanced Life Support (PALS);

• One certification from the NBRC or equivalent organization within 2 years of hire.(ex.CPFT,RPFT,ACRP,AE-C) in order to be eligible to sit for the CCRC or CCRP preferred.

Licensure(s): Colorado Respiratory Therapist License.

Salary Information
Pay is dependent on applicant's relevant experience.

Hourly Range: $31.55 to $47.32

Benefits Information
Here, you matter. As a Children's Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.

As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.

Children's Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.

EEO Statement
It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information. The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of attendance at or graduation from an educational institution. You will not be penalized for redacting or removing this information.