Clinical Research Assistant

Job Title Clinical Research Assistant Position Number 400173 Vacancy Open to All Candidates Time-Limited Yes Department Homepage https://medicine.ecu.edu/research-gradstudies/ Advertising Department CLINICAL TRIALS OFFICE Division ECU Health/BSOM Classification Title 12415 Social Clin Resrch Asst Competency Level 1 - Contributing Working Title Clinical Research Assistant Number of Vacancies 1 Full Time Equivalent (FTE) 1.0 Full Time or Part Time Full Time Recruitment Range $36,320 - $50,400 Anticipated Hiring Range $37,500 - $45,000 Salary Grade Equivalency GN08 Work Schedule M-F Work Hours 8-5 Position Location (City) Greenville Job Category Staff

• Medical Organizational Unit Overview

It is the mission of East Carolina University (ECU) Brody School of Medicine (BSOM) and ECU Health to provide exemplary medical education/training for physicians at the undergraduate and graduate levels. Additionally, it is the mission of BSOM to provide model comprehensive primary and consultative subspecialty care to patients in eastern North Carolina, to advance scientific knowledge through basic, translational, and clinical research, and to provide continuing medical education opportunities for physicians in the region. The Office of Clinical Research (OCR) will be a newly established central office in BSOM designed to support the management and conduct of clinical research while promoting compliance. This is accomplished through standardizing the approach to clinical research across the various research centers and departments in BSOM and ECU Health and supporting investigative teams through regulatory and operational assistance, and enhancements in study management and oversight.

Job Duties

Assist with Research Preparation, Enrollment, Data Collection & Reporting, including but not limited to 50%:

• Coordination: Assist the research team with study requirements to ensure the study is conducted according to the protocol, federal regulations, and institutional guidelines. Help develop materials, assist with procedures, and monitor research activities in conjunction with the sponsor/research team.

• Regulatory: assist in preparing and maintaining regulatory and study documentation, such as preparing Institutional Review Board applications, consent forms, patient binders, annual reports, and training guides and SOPs. Prepare all protocol required materials in order to successfully complete the study. Support the research coordinator and manager during monitoring visits and audits.

• Recruitment: screen patients for eligibility, consent / enroll subjects into studies, and help monitor enrollment goals.

• Data Management: assist with collecting data from patients and medical records, recording study data as prescribed by study protocol, exhibiting the highest ethics with regard to data collection, maintaining patient enrollment logs and files, analyzing of data to determine eligibility of patients to enroll, and participate in the study, using online programs to record data, and helping with site visits by the study sponsor. Assist with Adverse Event Reports as required by the study protocol. Work with the research investigators and research coordinators to resolve queries as needed.

• Support informed consent and provide patients with education about study participation and the expectations of participants (federal regulations, safety precautions). Help team with patient education about study protocol including risks involved, telephone follow-up with patients, following OSHA and HIPAA guidelines in all situations, and providing communicative access to study families for questions pertaining to the study.

• Other operational tasks as required.

Clinical/Patient Care 25%:

• Ensure procedures required by study protocol, such as laboratory tests, EKGs, echoes, x-rays, bone density, etc. are performed and documented correctly.

• Aid the lead coordinator with study-related procedures and assist with tracking timelines outlined in the protocol or study plan.

• Collect, process, and ship biospecimens.

• Other clinical duties as required.

Communication and Oversight 15%:

• Help the research coordinator and manager with documentation of enrollments and produces related reports as requested.

• Demonstrates a customer-focused style of communication, problem-solving, and collaboration

• Coordinates with internal functional departments to ensure various research activities are aligned with protocol, clinical flows, and those mutually agreed-upon timelines are met.

• Helps the team with process improvement through evaluation of workflows, development of documentation, and communication with key stakeholders.

• Direct and frequent communication with principal investigators and other clinical staff

• Must work as a part of a team. It is essential that this individual establish and consistently maintain a positive relationship with study participants, investigators, clinicians, coworkers, and related personnel. This individual may act as a liaison between institutional investigators, industry sponsors, reference laboratories, federal supervising agencies (NIH and FDA), and institutional personnel.

• This position will require direct communication with collaborating researchers, technicians, data coordinators, clinical and clerical personnel within the University and health system.

• This position also involves direct communication with patients (and potentially legal guardians) to see that they understand the purpose of the study and its risks and benefits.

• Attends team meetings, prepares reports, and communicates additional information around study activities as needed.

Financial 10%:

• Help the lead coordinator and clinical research finance team with documentation related to invoicing and budgeting including but not limited to Medicare coverage analysis, clinical trials participants list, and billing compliance. Communicate regularly with research financial analysts, research coordinator, and research manager when research procedures are conducted.

Minimum Education/Experience

Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

License or Certification required by statute or regulation

None

Preferred Experience, Skills, Training/Education

• Experience with human subject's research

• Familiarity with Electronic Medical Records (such as EPIC)

• Experience working on clinical research projects

• Experience working in a research lab or clinical setting

• CITI ethics training

License or Certification required by the Department

None

Special Instructions to Applicant

• Please ensure your full range of knowledge, skills, abilities, experience and education are listed on your application. Do not write 'see resume' on your application when completing the job duties section.

• If you answer the questions at the end of the application, please ensure your application reflects the knowledge, skills, abilities and experiences to support your answers (see job duties section of previous employment).

• Failure to answer the questions at the end of the application will not preclude your application from being considered but may result in your application not receiving full consideration of your knowledge, skills, and abilities.

• Applicants must be currently authorized to work in the United States on a full-time basis.

Job Open Date 06/17/2024 Job Close Date

• Positions will be posted until 11:59 p.m. EST on this date; If no closing date is indicated, the position will be posted until filled and may close at any time after the recruitment has been completed. 07/01/2024 Open Until Filled No Quick Link for Direct Access to Posting https://ecu.peopleadmin.com/postings/71692 Alternate option

If no applicants apply who meet the required competency level and training & experience requirements, then management may consider other applicants. Salary would be determined based on competencies, equity, budget, and market considerations.

AA/EOE

East Carolina University is an equal opportunity and affirmative action employer and seeks to create an environment that fosters the recruitment and retention of a more diverse student body, faculty, staff and administration. We encourage qualified applicants from women, minorities, veterans, individuals with a disability, and historically underrepresented groups. All qualified applicants will receive consideration for employment without regard to their race/ethnicity, color, genetic information, national origin, religion, sex, sexual orientation, gender identity, age, disability, political affiliation, or veteran status.

Individuals requesting accommodation under the Americans with Disabilities Act Amendments Act (ADAAA) should contact the Department of Human Resources at (252) 737-1018 (Voice/TTY) or ADA-Coordinator@ecu.edu.

Eligibility for Employment

Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. ECU participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States. If highest degree earned is from an institution outside of the U.S. and its territories, final candidates are required to have their degree validated as equivalent to the degree conferred by a regionally accredited college or university in the U.S.

Office of Human Resources Contact Information

If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (252) 328-9847 or toll free at 1-866-489-1740 or send an email to employment@ecu.edu. Our office is available to provide assistance Monday-Friday from 8:00-5:00 EST.