To manage a multi-institution clinical research study. To coordinate with study institutions, cores, committees, administrative team and study investigators.
1. Maintains a thorough working knowledge of the grant application for 17 or more study institutions, protocols, informed consents, IRB requests, manual of operations, and study documents.
2. Demonstrates basic knowledge of appropriate scientific background for study including: human genetics, epidemiology, COPD disease characteristics and common complications and co-morbid conditions, smoking and addiction, lung mechanics and pulmonary function testing, medical physics of CT scanning, blood processing and DNA extraction
3. Develops study, patient recruitment and educational materials. Works with Principal Investigator, Associate Director, Clinical Institution Director, and study coordinators on patient recruitment at all sites. Plans for the recruitment of over 10,000 research subjects.
4. Maintains and updates project website in collaboration with webmaster.
5. Evaluates study institution performance. Reviews spirometry data and troubleshoots problems such as malfunctioning spirometers. Teaches study coordinators about proper techniques for performing spirometry testing and six minute walks.
6. Ensures proper blood sample handling and storage techniques at the study sites.
7. Works with study coordinators concerning epidemiologic issues. Teaches about study design, consents, and inclusion and exclusion criteria. Informs study coordinators about patient questionnaires, validation and scoring.
8. Teaches study coordinators interpretation of CT cores. Identifies and corrects problems with CT scanners.
9. Works with study coordinators from all sites concerning DNA extraction and troubleshoots problems.
10. Prepares summaries and reports concerning study issues and problems for Executive Committee. Recommends action plans to resolve them.
11. Arranges regular conference calls and meetings of all committees including weekly executive committee meeting, regular coordinator calls, and twice yearly investigator meetings. Communicates with faculty and staff concerning teleconference schedules. Assists with developing meeting agendas. Writes minutes of conference calls and meetings.
12. Maintains and organizes all electronic and paper files of all project documents including IRB approvals, amendments, grant proposals, and protocols.
13. Performs all other duties as assigned.
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 institution-wide specific programs.
7. 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
Excellent interpersonal communication and organizational skills. Good command of the English language, both written and verbal. Excellent inter-personal and customer service skills. Ability to multi-task.
Bachelor degree, required. Masters degree in public health, biostatistics or related heath is preferred.
Certification and Licensure
Experience: 2 years of more in clinical research or current enrollment in a Masters program in public health, biostatistics or related health area. Experience in clinical trials management preferred.
- 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 may be required, 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 1700 employees in the worksite.