Senior Clinical Science Professional

University of Colorado•Aurora, CO

9d•Onsite

About The Position

Entry/Intermediate/Senior Clinical Science Professionals perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Entry/Intermediate/Senior Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Some Assignments will not move beyond the senior level. Examples of Duties Performed 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 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 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 Additional examples of work performed: Recruits and pre-screens potential study participants and coordinates advertisements via social media, flyers, etc. Manages study record in OnCore. Conducts the informed consent process and ensures proper documentation. Reviews protocol inclusion/exclusion criteria and confirms study eligibility. Assures protocol compliance and completes necessary records; maintains Standard Operating Procedures (SOPs). Accurately enters source data into the study database in a timely manner; reviews records after each visit for completeness and accuracy. Manages scheduling of participants, tracks subject participation, and runs study visits. Recognizes and tracks adverse events and serious events and promptly notifies appropriate parties. Attends lab and study team meetings. Collects and processes biological samples. Data entry and quality assurance reviews in REDCap and Excel. 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.

Requirements

Bachelor’s degree in any field
One (1) year clinical research or related experience
Two (2) years clinical research or related experience
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.
Applicants must meet minimum qualifications at the time of hire.
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
Strong communication and organizational skills
Ability to work collaboratively with study staff, postdoctoral researchers, undergraduates, principal investigators, hospital, clinic and lab staff
Ability to work occasional nights and weekends
Proficiency in Microsoft Office Suite
Ability to multitask and meet deadlines

Nice To Haves

Bachelor’s degree in science or health related field
Two (2) years of clinical research or related experience
Three (3) years of clinical research or related experience
Phlebotomy certification or equivalent or willing to obtain certification at our expense
Experience or comfort with handling biohazardous materials such as human blood, urine, and saliva samples
Familiarity with REDCap surveys and data entry
Experience conducting human subjects research visits or eligibility screenings

Responsibilities

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 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
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
Recruits and pre-screens potential study participants and coordinates advertisements via social media, flyers, etc.
Manages study record in OnCore.
Conducts the informed consent process and ensures proper documentation.
Reviews protocol inclusion/exclusion criteria and confirms study eligibility.
Assures protocol compliance and completes necessary records; maintains Standard Operating Procedures (SOPs).
Accurately enters source data into the study database in a timely manner; reviews records after each visit for completeness and accuracy.
Manages scheduling of participants, tracks subject participation, and runs study visits.
Recognizes and tracks adverse events and serious events and promptly notifies appropriate parties.
Attends lab and study team meetings.
Collects and processes biological samples.
Data entry and quality assurance reviews in REDCap and Excel.