To function as a member of the clinical research team in the implementation and coordination of clinical research.
- Is familiar with 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 National Jewish Policy and Procedures with particular emphasis in conducting multiple clinical research trials.
- Is familiar 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.
- 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
- Recruits and interviews prospective subjects for multiple clinical studies, consistently meeting or exceeding goals.
- 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.
- Properly dispenses study medication under the direction of the Principal Investigator and/or Sub-investigators.
- Assures compliance with protocol, completion of necessary records, and scheduling of monitoring and subject visits.
- Is familiar with all records required for each study, reviews records after each visit for completeness and accuracy.
- Transfers source documentation into Case Report Form (CRF) within 24 hours of subject visit.
- Maintains patient NJH and clinical research files, including updating medical history, allergies and concomitant medications on an ongoing basis.
- Shows initiative to identify and implement ways to improve their job and surroundings.
- Seeks supervision appropriately. Plans work in a manner that allows adequate completion of all tasks. Follows through on assignments in a timely manner.
- 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.
- 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.
- Demonstrates accuracy in all details, is able to record and report properly in patient records all pertinent information.
- 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.
- 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.
- 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.
- Performs all other duties as assigned
- Performs, as directed, safety compliance and uses Personal Protective Equipment (PPE), as needed.
- Participates in Quality Assessment (QA) and Quality Improvement (QI) programs, as directed.
- Ensures compliance with The Joint Commission and all other Federal, State and Regulatory Agencies.
- 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.
- 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.
- Increases customer service knowledge, skill and ability by participating in department and institution-wide specific programs.
- Incorporates National Jewish’s identity (Science Transforming Life®) into daily functions. Speaks positively about the institution, 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
Knowledge of basic human anatomy, physiology, laboratory procedures and equipment. Proven interpersonal communication, and organizational skills. Good command of the English language, both written and verbal.
BS or BA in Biology, Chemistry, Behavioral Science, Science, Health or Nursing required.
Certification and Licensure
BLS certification required prior to independent patient contact. IRB certification required within one month of hire. Certification for shipping hazardous materials (IATA) required prior to shipping any specimens.
A minimum of two (2) years of recent and relevant clinical experience, which may include performing as a medical assistant and/or comparable experience.
- or - Any equivalent combination of Education and/or Experience
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.
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.