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Clinical Research Coordinator III - Denver, CO - Permanent / Full Time - Staff - Nights

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Title: Clinical Research Coordinator III
Location: Denver, CO
Employment: Permanent / Full Time
Status: Open
Date Posted: 9 months ago9 months ago
Confirmed Open: 9 hours ago
Employer Name: National Jewish Health - Main Campus
Start Date: Wed, Aug 23, 2017
Shift: Nights
Hours: Open
Contact: Contact employer directly
Details:

Clinical Research Coordinator III

National Jewish Health is currently seeking a Clinical Research Coordinator III to join our dynamic and fast-paced

Clinical Research Services team. The candidate selected for this role will be an experienced coordinator who is organized, dedicated and detail focused with an in-depth knowledge of the federal regulations that pertain to clinical research as well as the tenets of ICH/GCP guidelines. The CRC III at National Jewish Health will have experience with scientific concepts related to study design and analysis, as well as substantial knowledge of the development process for drugs, biologics and medical devices. The candidate selected for this role will have a thorough understanding of the aspects of human subject protection and safety in the conduct of a clinical trial and will display leadership and professionalism by taking a mentoring role with newer coordinators. This position will impact the institution by working closely with our physician investigators to provide high-quality clinical research that informs our clinical practice and helps to improve and advance medical care.

The candidate selected for this position as a Clinical Research Coordinator III, would be responsible for study management and GCP compliance, safety management such as adverse event identification and reporting and will

possess the ability to function independently in a clinical research setting. The Clinical Research Services team is united by the National Jewish Health values, and works in a collaborative and supportive manner to achieve the institutions goals.

Why National Jewish Health? As the leading respiratory hospital in the nation for 118 years, our faculty is widely recognized for excellence in the treatment of lung diseases. We also conduct basic science, clinical and translational research in the areas of asthma, COPD, interstitial lung disease, cystic fibrosis, sleep disorders and other related conditions. Programs such as the new Autoimmune Lung Disease Center integrate clinical care and research across subspecialties.

General Summary

To function as a member of the clinical research team in the implementation and coordination of clinical research.

Essential Responsibilities

1. Is well versed in Good Clinical Practices, Food and Drug Administration Rules and Regulations, NIH guidelines, HIPAA regulations and ICH guidelines in relation to clinical trials. If not already familiar, become familiar with insitution Policy and Procedures with particular emphasis in conducting multiple clinical research trials.
2. Is fully knowledgeable with the purpose and the details of each protocol in which he/she will be involved (either as primary or backup coordinator) through review of the consent, protocol and IRB submission documents, avoiding deviations from the protocol.
3. Performs, on a very independent basis, all phases of experimental investigations, to include being responsible and collaborating with the Principal Investigator in the planning, developing, operating, recording, collaborating and reporting of major project as requested.
4. Works well as a member of the clinical research team with positive and timely written and verbal communication, including sharing information up, down and laterally.
5. Recruits and interviews prospective subjects for multiple clinical studies, consistently meeting or exceeding goals.
6. May perform routine and non-routine tests leading to the successful completion of developed experiments. Knows and follows age-specific guidelines.
7. Familiarizes potential subjects with the details of the study through phone contacts and personal interviews. Schedules subject participation in research, coordinating availability of necessary space, laboratory and physician support.
8. Properly dispenses study medication under the direction of the Principal Investigator and/or Sub-investigators.
9. Assures compliance with protocol, completion of necessary records, and scheduling of monitoring and subject visits.
10. Is familiar with all records required for each study, reviews records after each visit for completeness and accuracy.
11. Transfers source documentation into Case Report Form (CRF) within 24 hours of subject visit.
12. Maintains patient NJH and clinical research files, including updating medical history, allergies and concomitant medications on an ongoing basis.
13. Shows initiative to identify and implement ways to improve their job and surroundings.
14. Seeks supervision appropriately. Plans work in a manner that allows adequate completion of all tasks. Follows through on assignments in a timely manner.
15. Serves as a contact person for ongoing clinical research studies. Meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of study records.
16. May be called upon to perform the following specific tests and procedures: a) spirometry, b) electrocardiogram, c) prick and intradermal skin testing, d) blood pressure, pulse, height, weight, and temperature measurements e) nasal allergen challenges & nasal sampling, f) phlebotomy and specimen processing, g) methacholine challenges, h) breath condensate testing, i) nitric oxide measurements (nasal and/or pulmonary), j) sputum induction, k) bronchoscopy assisting, l) data collection and formatting into Excel for Biostatistics, as necessary per protocol.
17. Demonstrates accuracy in all details, is able to record and report properly in patient records all pertinent information.
18. Performs subject competencies (including age-specific competencies) as identified through the departmental competency program. Maintains compliance for training for specific tests and procedures, as needed per NJH policy and study protocol.
19. Implements care and services that recognize age-specific needs and issues for customers served. Performs as a back-up to staff absences and vacancies, as necessary.
20. Demonstrates adherence to the policies and procedures established by both NJH and their specific Unit. This includes but is not limited to, time and attendance policies.
21. Performs all other duties as assigned.

General Responsibilities

1. Performs, as directed, safety compliance and uses Personal Protective Equipment (PPE), as needed.
2. Participates in Quality Assessment (QA) and Quality Improvement (QI) programs, as directed.
3. Ensures compliance with The Joint Commission and all other Federal, State and Regulatory Agencies.
4. Responds promptly and sincerely to customer's needs, requests and concerns via all communication

forms using easily understood language and refraining from using inappropriate language and non-verbal gestures.

5. Maintains positive working relationships as a team player through problem solving issues, speaking positively about others, listening attentively and observing the Patient Bill of Rights and Confidentiality.
6. Increases customer service knowledge, skill and ability by participating in department and insitution-wide specific programs.
7. Incorporates National Jewish's identity (Science Transforming LifeĀ®) into daily functions. Speaks positively about the insitution, provides customers with prompt service, maintains a clean and safe working environment, dresses appropriately based upon National Jewish safety standards, and departmental policies and wears an ID badge visibly.

Knowledge and Skills

Extensive knowledge of standard research practices and methods, particularly in the field of assignment, and of other values of research in the field involved. Ability to determine the approach to a research problem which will give the most significant results and to develop, lay out and plan the actual experiments to be performed, and ability to devise new methods and techniques as needed in experimentation. Ability to plan, organize and direct work of supporting personnel. Ability to prepare and write reports on research projects. Ability to establish and maintain effective working relationships with

associates, other research personnel and the general public.

Education

BS or BA in Biology, Chemistry, Behavioral Science, Science, Health or Nursing required.

Certification and Licensure

CPR/BLS certification required prior to independent patient contact. Current IRB certification required within one month of hire. Certification for Shipping Hazardous Materials (IATA), required prior to shipping specimens. Current ACRP or SOCRA Clinical Research Coordinator Certification (CCRC or CCRP), or Clinical Research Associate Certification (CCRA), preferred.

Work Experience

A minimum of five (5) years of Clinical Research experience with a minimum of two (2) years experience equivalent to a CRC level II.

  • or - Any equivalent combination of Education and/or Experience
  • Working Conditions

    Position is in a clinical environment. Frequent requirements may include: reading and comprehending medical literature, including basic interpretation of disease processes, medical charts, and instructions. Communication includes ability to chart vital signs and other basic information. Communication with interdisciplinary team as well as with differing ages and levels of maturity/understanding of patient and family, taking and recording telephone messages. Manual dexterity, manipulating equipment such as blood pressure kit, oximeter, spirometer. Frequently, has the need to assist a patient by moving or lifting. Considerable physical demands, requiring lifting up to 25 pounds Also involves pushing wheelchairs, opening doors and cabinets, reaching for objects. Occasionally will need to crawl in order to retrieve a fallen object for a patient. Occasional requirements may include: sitting while completing paperwork, kneeling, and squatting. Incumbent may be scheduled to work an alternate schedule to accommodate essential business needs routine travel by foot or automobile to alternate work/meeting locations, possibly during inclement weather.

    Environmental Conditions

    Inside environmental conditions may include: The potential of coming into contact with bloodborne pathogens. Has frequent exposure to infectious diseases. Occasionally, may encounter radiation from portable radiology procedures. May come into contact with various fumes/odors. Also may encounter contaminated biological waste from infectious patients. Personal Protective Equipment (PPE) will be provided to each employee when needed as determined by policy. Utilization of PPE is mandatory. Estimated 1500 employees in the worksite.

    Management/Supervisory Responsibilities

    None

    Industry: Healthcare

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    Time From To Job Text
    12/22/16 5:41 AM
    Updated (8 months ago)
    SystemSystem1588567Status: New
    Specialty: Clinical Research Unit Clinical Research Coordinator III
    Location: Denver, CO
    Employment Type: Permanent / Full Time
    New job was posted by system.
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