Site Feasibility Specialist II - IQVIA Biotech
IQVIA Biotech is now hiring a Site Feasibility Specialist II.
Responsible for following the appropriate processes for collecting Confidential Disclosure Agreements (CDA) and Feasibility Questionnaires (FQ) from sites. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained follow International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. A Site Feasibility Specialist II may be assigned to one or more start-up projects, and typically is able to work independently on a project with minimal supervision.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Provides updates during weekly client teleconferences, client meetings, and internal team meetings.
- Liaise with Clinical Monitoring, Site Start Up, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
- Creates/Coordinate the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for sponsor review, as required. Works with PM to obtain client approval of the study specific feasibility questionnaire, as needed.
- May support Site Feasibility Lead/Manager in working with client to obtain/agree to study specific Confidential Disclosure Agreement (CDAs) Template for a study.
- Distribute Confidential Disclosure Agreements (CDAs) and feasibility questionnaire to sites and follow up with sites accordingly to ascertain interest and to meet study timelines.
- May review and negotiate the CDAs according to country specific requirements, seeking legal/management review when required.
- Documents/escalates study challenges and communicates updates to Project Manager and SSU Lead/Management.
- Maintains quality and regulatory compliance among investigational sites during Site Feasibility.
- Maintains up to date and accurate tracking on the Site Feasibility status for each site in applicable system(s) for the study.
- Liaise with team members to understand budgets for the studies they are working on and are accountable for maintaining project activities within documented scope and budget.
- Identifies out of scope activities to Site Feasibility Management, Project Manager and team and assures that such activities do not begin until the appropriate authorization is provided.
- Responsible for transitioning sites from Site Feasibility to SSU representative.
- Provides updates to Lead/Manager on a regular basis and communicates any out of scope activities.
- Participates in financial and/or resource forecasting, as applicable.
- Performs other duties as required.
KNOWLEDGE, SKILLS & ABILITIES:
- Good knowledge of clinical research process related to study start-up and medical terminology
- An understanding of Regulatory and Central/Local ethic submission processes for assigned countries
- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
- Excellent organizational and interpersonal skills
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
- Ability to manage multiple competing priorities within various clinical trials
- Working knowledge of current ICH GCP guidelines and applicable regulations
- Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor junior SSU staff
- Excellent verbal and written communication skills required in local language for assigned countries.
- Ability to work independently, prioritize and work with a matrix team environment is essential.
- Working knowledge of Word and Excel is required.
- Ability to travel periodically if needed
MINIMUM RECRUITMENT STANDARDS:
- Bachelor’s degree (or equivalent) in science-related field preferred and
- 2-4 years relevant experience
- Equivalent combination of education, training and experience
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
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