Clinical Research Contract and Start Up Specialist

Job Title:

Clinical Research Contract and StartUp Specialist

Position Number:

002581

Vacancy Open to:

All Candidates

Time-Limited:

No

Department Homepage:

https://clinicaltrials.ecu.edu/about/

Advertising Department:

CLINICAL TRIALS OFFICE

Division:

ECU Health/BSOM

Classification Title:

10301 University Program Speci

Competency Level:

3 - Advanced

Working Title:

Clinical Research Contract and StartUp Specialist

Number of Vacancies:

1

Full Time Equivalent (FTE):

1.0

Full Time or Part Time:

Full Time

Recruitment Range:

$31,888 - $76,466

Anticipated Hiring Range:

$65,443 - $67,510

Salary Grade Equivalency:

GN13

Work Schedule:

M-F

Work Hours:

8am - 5pm

Position Location (City):

Greenville

Job Category:

Staff - Professional

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 :

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 the contract consultation process for teams and study is properly aligned to the critical path for site activation

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

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. Communicates with sponsors about regulatory information.
• Prepares and reviews Informed Consent Forms and other regulatory documents per federal, state, and institutional guidelines.
• Responds to ancillary queries in a timely manner, revises IRB application 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.

CLINICAL SUPPORT POSITION – NOT SUBJECT TO STATE HUMAN RESOURCES ACT.
The Brody School of Medicine at East Carolina University is affiliated with ECU Health Medical Center, which serves as its teaching hospital, as well as the flagship hospital for ECU Health.
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:

None

Preferred Experience, Skills, Training/Education:

An understanding of University policies and procedures related to Clinical Research is preferred. Experience in Clinical Research Contract negotiations is highly desirable. Experience as a regulatory coordinator, Clinical Research coordinator, or paralegal is desirable.

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:

01/03/2024

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. :

01/25/2024

Open Until Filled:

No

Quick Link for Direct Access to Posting:

https://ecu.peopleadmin.com/postings/62945

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.