Functions as a traveling research coordinator to clinical centers across the United States working with local research teams or independently to develop, implement and coordinate clinical research. This position will perform diverse administrative duties requiring analysis, sound judgement and a high level of study specific protocol. Travel to other clinical centers across the United States throughout the calendar year will be required.
- Daily logging and reporting of activities.
- Organizational skills related to travel, including but not limited to: booking/securing travel arrangements, saving all travel related receipts, and submitting receipts for reimbursement.
- 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.
- Become familiar with institution Policy and Procedures for National Jewish Health and each institution that he/she travels to.
- Is fully knowledgeable with the purpose and the details of study protocol in which he/she will be involved 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.
- Exhibits positive behaviors interacting with colleagues and study subjects, sets a tone for effective communication at each new site.
- Recruits and interviews prospective subjects for the clinical study, 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.
- May be called upon to perform the following specific tests and procedures, including others not listed: a) spirometry and other pulmonary function tests, b) electrocardiogram, c) blood pressure, pulse, height, weight, and temperature measurements d) phlebotomy and specimen processing, e) data collection and formatting into Excel, as necessary.
- 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.
- Incorporated 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 in ID badge visibly.
Knowledge and Skills
Excellent interpersonal communication and organizational skills is a must. Good command of the English language, both written and verbal. Excellent customer service skills required. Ability to multi-task. Must be able to function independently. Ability to use email and Microsoft Office Suites required.
Extensive knowledge of standard research practices and methods. Ability to recognize problems and determine the course of action which will give the best outcome. Ability to plan, organize and direct work of supporting personnel. Ability to prepare and write reports of work on daily basis. Ability to establish and maintain effective working relationships with peers, associations, and the general public. Experience in phlebotomy is preferred or desire to learn quickly.
Certification and Licensure
Must have a valid driver’s license. Local IRB certification will be required prior to or within 1 week of arriving at any clinical center. This includes HIPAA and GCP training, as well as any institutional training required at each local center. CPR/BLS certification may be required at each clinical center prior to independent patient contact. Current ACRP or SOCRA Clinical Research Coordinator Certification (CCRC or CCRP), or Clinical Research Associate (CCRA), preferred.
BS or BA required.
Minimum three (3) years of work experience with minimum of two (2) years of experience functioning as a clinical research coordinator or clinical research monitor preferred.
- or - Any equivalent combination of Education and/or Experience.
Up to 75% travel by car, train, or plane may be required to clinical centers, possibly during inclement weather. May need to work an alternate schedule to accommodate essential business needs. 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, and spirometer. Frequently, has the need to assist a patient by moving or lifting. Considerable physical demands, requiring lifting up to 25 pounds. Also involved pushing wheelchairs, opening doors and cabinets, reaching for objects. Occasionally will need to crawl in order to receive a fallen object for a patient. Occasional requirements may include: sitting while completing paperwork, kneeling and squatting.
Inside environmental conditions may include: the potential of coming into contact with blood borne 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 1700 employees in the worksite in Denver.