Register
Recruit Create CV
Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords
Some similar recruitments
Research Specialist I Jobs
Recruited by Princeton University 8 months ago Address , Princeton, 08542
Clinical Research Associate Ii
Recruited by BeiGene 8 months ago Address , Remote $90,500 - $120,500 a year
Packer ( 12Hr. Shifts, 545Am-6Pm) $17.50/Hr.
Recruited by Tekni-Plex 8 months ago Address , Decatur, 46733 $17.50 an hour
Clinical Research Associate Jobs
Recruited by Philips 8 months ago Address , Cambridge
Director, Study Start-Up Jobs
Recruited by Care Access 8 months ago Address , Remote
Solution Specialist, Safety, Clinical Research
Recruited by Verily 8 months ago Address , Remote
Clinical Research Associate - Sponsor Dedicated
Recruited by IQVIA 9 months ago Address , Remote
Driver Cdl/Warehouse Associate - Earn Additional 17K To Start
Recruited by Mondelēz International 9 months ago Address , Montgomery $31.30 an hour
Clinical Research Associate, Sponsor Dedicated
Recruited by IQVIA 9 months ago Address , Remote
Clinical/Hc Research Associate
Recruited by University of Iowa 11 months ago Address Iowa City, IA, United States
Senior Clinical Research Associate
Recruited by Premier Research 11 months ago Address , Remote
Clinical Software Support Specialist I
Recruited by Cochlear Ltd 11 months ago Address , Lone Tree, 80124, Co $28.85 an hour
Senior Tech Staffing Recruiter
Recruited by EX2 Outcoding 11 months ago Address , Remote
Senior Clinical Research Associate (Phase I Oncology)
Recruited by Premier Research 11 months ago Address , Remote
Clinical Research Associate I (Home-Based In Us)
Recruited by Syneos Health Clinical 11 months ago Address , Remote $55,800 - $93,067 a year
Associate Study Start-Up Manager
Recruited by BeiGene 11 months ago Address , Remote $92,900 - $127,900 a year
Research Data Specialist ($25/Hour)
Recruited by WCG 11 months ago Address , Puyallup, Wa $25 an hour
Maintenance Trainee 6Pm - 6Am
Recruited by Campbell Soup Company 1 year ago Address , Bloomfield, 06002, Ct $33.80 an hour
Clinical Research Coordinator I
Recruited by Regions Hospital 1 year ago Address , Saint Paul, 55101, Mn
Clinical Research Associate - Medical Device
Recruited by Meridian Bioscience, Inc. 1 year ago Address , Remote
Clinical Research Associate - Home-Based (Southeast)
Recruited by ICON 1 year ago Address , Remote
Um Administrative Coordinator- Medicare- Wah Mon-Fri 9Am-6Pm Est
Recruited by Humana 1 year ago Address , Tampa, 33610, Fl
Central Study Coordinator Jobs
Recruited by Care Access 1 year ago Address , Remote
Up & Up Grant Project Manager - College Of Nursing
Recruited by University of Tennessee 1 year ago Address , Knoxville, Tn
Clinical Research Associate - Home-Based (Colorado And Midwest)
Recruited by ICON 1 year ago Address , Remote
Clinical Research Associate Iii - Remote
Recruited by Orthofix 1 year ago Address , Remote
Clinical Research Associate - Home-Based (North East, Usa)
Recruited by ICON 1 year ago Address , Remote
Research Study Coordinator Jobs
Recruited by Boston Medical Center 1 year ago Address , Remote
Clinical Research Associate 2/3 - Biotech
Recruited by ICON 1 year ago Address , Remote
Clinical Research Associate Ii
Recruited by Labcorp 1 year ago Address , Allentown, 18104, Pa $90,000 - $125,000 a year
Senior Research Specialist I
Recruited by Princeton University 1 year ago Address , Princeton, 08542, Nj
Research Specialist I Jobs
Recruited by Princeton University 1 year ago Address , Princeton, 08542, Nj
Clinical Research Associate (Cra)
Recruited by ClinSmart 1 year ago Address , Remote

Clinical Research Contract And Start Up Specialist

Company

East Carolina University
Address , Greenville, Nc
Employment type CONTRACTOR
Salary
Expires 2023-06-09
Posted at 1 year ago
Job Description

30%
Negotiating, executing and awarding contracts:
  • 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.
  • Liaises and establishes effective relationships with sponsors, study teams, and ancillary stakeholders.
  • Ensures alignment of contract consultation process for teams and study are properly aligned to the critical path for site activation
20%
Preparing and reviewing budgets and other supporting documents
  • Identifies and assesses legal, financial and operational risks and raises to appropriate level of the organization per established processes
  • Prepares and reviews budgets, templates and supporting documents.
30%
Regulatory documentation and IRB applications Reporting:
  • Responds to ancillary queries in a timely manner, revises IRB application as needed, and submits amendments and protocol deviation information when required.
  • Prepares and reviews Informed Consent Forms and other regulatory documents per federal, state, and institutional guidelines.
  • Assists with study regulatory maintenance.
  • Oversee ethics and regulatory bodies submissions and approval status. Coordinate addressing queries and ensuring required timelines are met. Communicates with sponsors around regulatory information.
20%
Communication and Oversight:
  • Demonstrates a customer focused style of communication, problem solving and collaboration
  • 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. Consult and collaborate with the clinical research management team to ensure clinical research studies remain on track for timely start up and initiation.
  • 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.
  • 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.


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 University policies and procedures related to clinical research is preferred. Experience in clinical research contract negotiations is highly desirable. Experience as a regulatory coordinator, a clinical research coordinator, or a paralegal is desirable.

License or Certification required by the Department
N/A

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
03/27/2023

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.
04/10/2023

Open Until Filled
No

Quick Link for Direct Access to Posting
https://ecu.peopleadmin.com/postings/60399

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[email protected].

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 [email protected]. Our office is available to provide assistance Monday-Friday from 8:00-5:00 EST.