Job Information
University of Colorado Research Services Senior Principal Professional (Research Services Professional, Clinical Sciences) Open Rank in Aurora, Colorado
Research Services Senior – Principal Professional (Research Services Professional, Clinical Sciences) Open Rank - 34041 University Staff
Description
University of Colorado Anschutz Medical Campus
Department: Emergency Medicine
Job Title: Research Services Senior – Principal Professional (Research Services Professional, Clinical Sciences) Open Rank
Position: # '00824472 – Requisition: # 34041
Job Summary:
Professional Field
Supervision Received
Supervisory Authority
Key Responsibilities:
General Duties:
Assist with and oversee the day-to-day operations of clinical trials and studies
Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
Collect, code, and analyze data obtained from research in an accurate and timely manner
Adhere to research regulatory standards
Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
Ensure that the necessary supplies and equipment for studies are in stock and in working order
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
Act as a Primary Coordinator on multiple trials/studies
Assist and train junior team members
Senior Professional and all the above:
Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
Assist with identifying issues related to operational efficiency and shares results with leadership
Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
Serve as a resource and participate in study initiation and close out duties
Principal professional and all the above:
Coordinate and administer patient care in compliance with protocol requirements
Disburse investigation drug and provide patient education regarding administration
Oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Independently review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document and report all findings to physician and care team
Additional Duties & Responsibilities:
Assist with budget creation and grant submissions
DOD regulatory and technical reporting submissions
Manage and conduct moderately complex research activities that are part of larger project from initiation to close.
Create complex data management and tracking tools (REDCap, Excel) to support tracking of project/recruitment activities.
Oversee student worker(s) or junior PRAs as it relates to a specific project.
Participate in instrument creation (REDCap) and/or analytical structures as appropriate to the project.
Collect study data via complex patient visits, surveys, observations or focus groups. Provide leadership in data collection to other PRAs and students.
Participate in audits, monitoring visits, and quality control checks of data collection, equipment maintenance, and study procedures.
Help develop study findings for presentation to team and external audiences.
May lead publication development (abstract/manuscript)
Help with budget management/tracking (under direction of PM/PI)
Lead manuscript preparation for publication or presentation in scientific forums.
Work with members of the UCD and UCHealth community as needed to set up labs, participant visits, and access shared University resources.
Manage study participant incentive program with the assistance of procurement.
This description is a summary only and describes the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.
Work Location:
Hybrid
Why Join Us:
Position: # '00824472 – Requisition: # 34041
Job Summary:
Professional Field
Supervision Received
Supervisory Authority
Key Responsibilities:
General Duties:
Assist with and oversee the day-to-day operations of clinical trials and studies
Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
Collect, code, and analyze data obtained from research in an accurate and timely manner
Adhere to research regulatory standards
Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
Ensure that the necessary supplies and equipment for studies are in stock and in working order
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
Act as a Primary Coordinator on multiple trials/studies
Assist and train junior team members
Senior Professional and all the above:
Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
Assist with identifying issues related to operational efficiency and shares results with leadership
Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
Serve as a resource and participate in study initiation and close out duties
Principal professional and all the above:
Coordinate and administer patient care in compliance with protocol requirements
Disburse investigation drug and provide patient education regarding administration
Oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Independently review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document and report all findings to physician and care team
Additional Duties & Responsibilities:
Assist with budget creation and grant submissions
DOD regulatory and technical reporting submissions
Manage and conduct moderately complex research activities that are part of larger project from initiation to close.
Create complex data management and tracking tools (REDCap, Excel) to support tracking of project/recruitment activities.
Oversee student worker(s) or junior PRAs as it relates to a specific project.
Participate in instrument creation (REDCap) and/or analytical structures as appropriate to the project.
Collect study data via complex patient visits, surveys, observations or focus groups. Provide leadership in data collection to other PRAs and students.
Participate in audits, monitoring visits, and quality control checks of data collection, equipment maintenance, and study procedures.
Help develop study findings for presentation to team and external audiences.
May lead publication development (abstract/manuscript)
Help with budget management/tracking (under direction of PM/PI)
Lead manuscript preparation for publication or presentation in scientific forums.
Work with members of the UCD and UCHealth community as needed to set up labs, participant visits, and access shared University resources.
Manage study participant incentive program with the assistance of procurement.
This description is a summary only and describes the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.
Work Location:
Hybrid
Why Join Us:
Diversity and Equity:
Qualifications:
Minimum Qualifications:
Bachelor's degree in any field
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
Two (2) years clinical research or related experience
Bachelor's degree in any field
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
Optional Substitution : Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.
Three (3) years clinical research or relate experience
Preferred Qualifications:
Four (4) years of clinical research or related experience
Bachelor of Science in Nursing (BSN) degree
An Associate Degree in Nursing (ADN) degree and two (2) additional years of experience will substitute for the BSN degree
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
Current licensure as a registered nurse
Required: Applicants must meet minimum qualifications at the time of hire.
Knowledge, Skills, and Abilities:
Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
Ability to communicate effectively, both in writing and orally
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
Outstanding customer service skills
Demonstrated commitment and leadership ability to advance diversity and inclusion
Knowledge of basic human anatomy, physiology medical terminology
Ability to interpret and master complex research protocol information
How to Apply:
Screening of Applications Begins:
Anticipated Pay Range:
or hiring range
ADA Statement:
Background Check Statement:
Vaccination Statement:
Job Category
Primary Location
Schedule
Posting Date
Unposting Date
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The Injury Generated by Burn and Frostbite (IGNITE) lab in the Department of Emergency Medicine has an opening for a full-time University Staff (unclassified) Research Services Senior- Principal Professional position. IGNITE conducts clinical research, focusing on clinical trials in the acute care setting with a particular focus on early interventions for critically injured burn and frostbite patients. IGNITE receives significant funding from the Department of Defense. The University of Colorado Denver | Anschutz Medical Campus| Department of Emergency Medicine, is currently seeking applications for a Research Services Open Rank (Senior to Principal) Professional. This is a full-time, University Staff (non-classified) position, for the IGNITE lab. The Department of Emergency Medicine and IGNITE lab seeks motivated applicants for the position of Clinical Science Professional. This role will engage patients, families, and clinical staff at the University of Colorado Hospital, manage study start-up and documentation for clinical trials, collaborate with clinical and research teams working to improve care of critically injured burn and frostbite patients. The projects focus on patients in the Emergency Department and Burn Intensive Care Units with critically injured burn and frostbite patients. The ideal candidate will have experience within research (clinical or laboratory), collaborate effectively on multidisciplinary teams, and be highly detail oriented. Clinical Sciences, Research This position will report directly to the ATLAS Principal Investigator and ATLAS Manger None
– 4 days on-site, this role is expected to work onsite and is located in City, State.
The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://apptrkr.com/get_redirect.php?id=5359564&targetURL=Research Services Senior – Principal Professional (Research Services Professional, Clinical Sciences) Open Rank
The Injury Generated by Burn and Frostbite (IGNITE) lab in the Department of Emergency Medicine has an opening for a full-time University Staff (unclassified) Research Services Senior- Principal Professional position. IGNITE conducts clinical research, focusing on clinical trials in the acute care setting with a particular focus on early interventions for critically injured burn and frostbite patients. IGNITE receives significant funding from the Department of Defense. The University of Colorado Denver | Anschutz Medical Campus| Department of Emergency Medicine, is currently seeking applications for a Research Services Open Rank (Senior to Principal) Professional. This is a full-time, University Staff (non-classified) position, for the IGNITE lab. The Department of Emergency Medicine and IGNITE lab seeks motivated applicants for the position of Clinical Science Professional. This role will engage patients, families, and clinical staff at the University of Colorado Hospital, manage study start-up and documentation for clinical trials, collaborate with clinical and research teams working to improve care of critically injured burn and frostbite patients. The projects focus on patients in the Emergency Department and Burn Intensive Care Units with critically injured burn and frostbite patients. The ideal candidate will have experience within research (clinical or laboratory), collaborate effectively on multidisciplinary teams, and be highly detail oriented. Clinical Sciences, Research This position will report directly to the ATLAS Principal Investigator and ATLAS Manger None
– 4 days on-site, this role is expected to work onsite and is located in City, State.
The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=5359564&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
Senior Professional: Principal Professional:
For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position 2. Curriculum vitae / Resume 3. Three to five professional references including name, address, phone number (mobile number if appropriate), and email address
Immediately and continues until position is filled
The starting salary range () for this position has been established as Principal: $63,702 - $81,029 Senior: $55,393 - $70,460 The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation depending on the level. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line. Total Compensation Calculator: http://www.cu.edu/node/153125 (https://apptrkr.com/get_redirect.php?id=5359564&targetURL=http://www.cu.edu/node/153125)
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5359564&targetURL=hr.adacoordinator@cuanschutz.edu) .
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get_redirect.php?id=5359564&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program (https://apptrkr.com/get_redirect.php?id=5359564&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .
Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 20353 - SOM-EM MED CLINICAL : Full-time : Jun 25, 2024 : Ongoing Posting Contact Name: Hailey He Posting Contact Email: hailey.he@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5359564&targetURL=hailey.he@cuanschutz.edu) Position Number: 00824472jeid-269695625fabdc4f876da6be7b74642f
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.