Senior Clinical Science Professional- Maternal/Fetal Medicine

Description
University of Colorado | CU Anschutz Medical Campus

School of Medicine, Department of Obstetrics and Gynecology  

Official Title: Research Services Senior Clinical Science Professional

Working Title: Senior Clinical Science Professional- Maternal/Fetal Medicine

Position #796516  – Requisition #25851

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date.  Information regarding this requirement, and exemptions can be found at:

Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2

Denver: https://www.ucdenver.edu/coronavirus

Exemptions vary by campus location/department.

Campus/Unit-Specific Exemptions:

Anschutz Campus – Accommodations may be granted for medical or religious reasons.Denver Campus - Exemptions are allowed for medical, religious, or personal reasons.Consolidated/Central Services Administration – Accommodations may be granted for medical or religious reasons.

The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here.

The School of Medicine’s Department of Obstetrics and Gynecology has an opening for a full-time University Staff (unclassified) Research Services Senior Clinical Science Professional in Maternal/Fetal Medicine.

Jobs in the Research Services career family provide direct professional support of research activities.  Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.

Senior Professionals are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying and sharing knowledge directly related to a professional field.  Work is performed fully independently.

Nature of Work

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. 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 this level.

This Clinical Science Professional- Maternal/Fetal Medicine will serve as a project and data manager under the direction of the Principal Investigator, Dr. Bettina Cuneo, for the STOP BLOQ Trial. The STOP BLOQ trial is an innovative multi-center trial sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.  This position has been designed to interact with study personnel at NYU and other Midwest and West coast study sites to optimize recruitment and retention of study participants. The position will serve as a liaison and care coordinator for multiple (8-12) recruitment sites.

The professional is expected to be available to troubleshoot any questions from the collaborating institutions and/or the study participants. They will communicate directly with co-investigators at the participating centers to support recruitment and ensure quality data collection. They will engage in weekly teleconference meetings with Principal Investigators Dr. Cuneo and Dr. Buyon, and monthly teleconference meetings with all study collaborators and site-PIs. They will prepare study progress summaries for collaborator meetings (monthly), DSMB meetings (biannually), NIH reports (annually), and study presentations (as needed).

Examples of Duties Performed

Project management across multiple (8-12) study sites, subject recruitment, and retention, study visit coordination, data collection and entry, data query resolution and analyzation for submission to grantor or for publication, maintenance of certification and communication with the Institutional Review Board and the sponsoring agency or its designee. 

• 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
• 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
• Train eligible study participants to conduct fetal heart rate monitoring (FHRM) and listen and respond to their 3x/day FHRM recordings during the second trimester

This description is a summary only and is describing 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.

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

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications

• Bachelor’s degree in science or health related field
• Three (3) years of clinical research or related experience
• One year or equivalent using statistical software (e.g. SAS®, SPSS®) and running statistical analyses
• One year experience utilizing multiple Electronic Data Capture systems
• One year experience using REDCap or equivalent to build and manage multiple projects
• One year of experience as a research project manager
• Fluency in Spanish
• Experience in project management in biomedical or public health research, such as development and enactment of study protocols, management of research databases, data quality control, statistical analysis, and development of charts and tables
• Experience with recruitment and supervision of research subjects and study visits.

Competencies, Knowledge, Skills, and Abilities

This is a position requiring an enthusiasm for medical research and knowledge or interest in women’s health. The candidate will be self-directed, detail-oriented, and adaptable in a high-intensity research environment.

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
• Solid fundamental knowledge of biological and medical sciences
• Strong background supporting multi-institutional and multi-disciplinary collaborations
• Proficiency in writing and editing of peer-reviewed manuscripts, reports, and research grants
• Skilled in reviewing clinical research protocols and demonstrating the ability to translate into implementation including reviewing visit schedules, arranging and coordinating study visits with clinical staff and faculty, and overseeing all regulatory requirements and documentation
• 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
• Strong skills in organization and attention to detail, to ensure accurate documentation as required by all studies being performed
• 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
• Proficiency in Microsoft products (e.g. Excel®, Powerpoint®, Outlook®)
• Demonstrated ability to manage multiple aspects of complex projects and programs
• Demonstrated ability to work independently

Condition of Employment

Must be able to pass a criminal background check and drug testing

Salary and Benefits

The salary range (or hiring range) for this position has been established at $52,239 – 66,448.

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible for overtime compensation.

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.

Benefits: https://www.cu.edu/employee-services/benefits

Total Compensation Calculator: http://www.cu.edu/node/153125

Diversity and Equity

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 [email protected].

The University of Colorado Denver | 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 and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The University of Colorado Denver | 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.

Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: May 3, 2022
Unposting Date: Ongoing