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Study Startup

4 months ago

Greenville, North Carolina, United States East Carolina University Full time
Posting Details

Position Information

Job Title
Study Startup & Contract Specialist

Position Number
TN0281

Vacancy Open to
All Candidates

Department
EHH BSOM R and GS Admin

Department Homepage

Advertising Department
CLINICAL TRIALS OFFICE

Division
ECU Health/BSOM

Classification Title

Working Title
Study Startup & Contract Specialist

Number of Vacancies
1

Full Time Equivalent (FTE)
.75

Full Time or Part Time
Part Time

Anticipated Recruitment Range. Salary offered may be outside of this range as impacted by budget, UNC salary administration, and/or candidate qualifications.
Commensurate with Qualifications

Position Location (City)
Greenville

Position Type
Non-Faculty

Job Category
Non-Faculty Staff Professional

Primary Function of Organizational Unit

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

The Clinical Research Start-Up Specialist will aid in streamlining the study startup process for clinical research studies at ECU and ECU Health by working closely with the study sponsors, research teams, and the UMCIRB office. This team member will manage a portfolio of departments within the enterprise and support investigators and research support staff in these departments with the study start-up process. This team member will assist with the development of site activation strategies, and startup workflows, and oversee start-up delivery and governance. This position will be responsible for negotiating, executing, and awarding contracts, preparing and reviewing budgets and other supporting documents, assisting with regulatory documentation and IRB applications, and training research support staff.

30% Negotiating, executing, and awarding contracts:
  • Liaises and establishes effective relationships with sponsors, study teams, and ancillary stakeholders.
  • Prepares and negotiates study and vendor contracts, as well as awards clinical research studies within the contract management system.
  • Works directly with sponsors, academic collaborators, and other parties to resolve research contract issues. Ensures quality, objectivity, and risk analysis in the efficient delivery of contracts.
  • Ensures alignment of contract consultation process for teams and study are properly aligned to the critical path for site activation.
30% Regulatory documentation and IRB applications Reporting:
  • Oversee ethics and regulatory bodies' submissions and approval status. Coordinate addressing queries and ensuring required timelines are met. Communicate with sponsors about regulatory information.
  • Prepares and reviews Informed Consent Forms and other regulatory documents per federal, state, and institutional guidelines.
  • Respond to ancillary queries in a timely manner, revise IRB applications as needed, and submit amendments and protocol deviation information when required.
  • Assists with study regulatory maintenance.
20% Communication and Oversight:
  • Maintains documentation of contracts, IRB application status, and other KPIs, tracks metrics and outcomes, and produces related reports. Consult and collaborate with the clinical research management team to ensure clinical research studies remain on track for timely start-up and initiation.
  • Demonstrates a customer-focused style of communication, problem-solving, and collaboration.
  • Communicates, receives, and understands information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Performs successfully under pressure while prioritizing and handling multiple projects or activities.
  • Coordinates with internal functional departments to ensure various startup activities are aligned with contractual activities and mutually agreed-upon timelines.
  • Maintains documentation of contracts, IRB application status, and other KPIs, tracks metrics and outcomes, and produces related reports.
  • Conducts process improvement through evaluation of workflows, development of documentation, and communication with key stakeholders.
20% Preparing and reviewing budgets and other supporting documents:
  • Prepares and reviews budgets, templates, and supporting documents.
  • Identifies and assesses legal, financial, and operational risks and raises them to the appropriate level of the organization per established processes
Contingent upon the availability of funds

Minimum Education/Experience

Bachelor's degree and one year of experience related to the area of assignment; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions

License or Certification Required by Statute or Regulation

N/A

Preferred Experience, Skills, Training/Education

An understanding of policies and procedures related to clinical research is preferred. Previous experience in clinical research contract negotiations is highly desirable. Previous experience as a regulatory coordinator, a clinical research coordinator, or a paralegal is desirable.

License or Certification Required by the Department

Special Instructions to Applicant

Applicants must be currently authorized to work in the United States on a full-time basis. At the time of employment two to three original letters of reference, official transcripts, a criminal background check, and proper documentation of identity and employability are required. Please be aware that if selected for an interview, an automatic e-mail will be sent to the individuals entered by the applicant in the references section of the PeopleAdmin applicant tracking system. Letters of reference submitted via the PeopleAdmin applicant tracking system will be verified and considered for meeting this requirement.

Additional Instructions to Applicant

In order to be considered for this position, applicants must complete a candidate profile online via the PeopleAdmin system and submit any requested documents. Additionally, applicants that possess the preferred education and experience must also possess the minimum education/experience, if applicable.

Job Open Date
05/14/2024

Open Until Filled
Yes

Job Close Date - Positions will be posted until 11:59 p.m. EST on this date. If no closing date is indicated, the position may close at any time after the initial screening date.

Initial Screening Begins
05/28/2024

Rank Level
Not Applicable

Quick Link for Direct Access to Posting

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 Voice/TTY) or ADA-.

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 or toll free at or send an email to Our office is available to provide assistance Monday-Friday from 8:00-5:00 EST.