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About the Role
Perform monitoring and site management work to ensure sites are conducting studies and reporting data as required by the protocol, regulations, and sponsor requirements.
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Requirements
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least 2 years of year of independent on-site monitoring experience as a Clinical Research Associate (CRA) in a CRO, sponsor, or similar setting.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Must have experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems in support of monitoring activities.
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Skills
- Good Clinical Practice (GCP)
- International Conference on Harmonization (ICH) guidelines
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- EDC
- CTMS
- eTMF
- IVRS/IWRS
- Clinical trial systems
- English language
- Organizational skills
- Problem-solving skills
- Time management skills
- Financial management skills
Location
- Same country where the job is located
Work Type
- Full-time
Experience Level
- At least 2 years of independent on-site monitoring experience as a Clinical Research Associate (CRA)
Education Level
- Bachelor's Degree in scientific discipline or health care preferred
- Equivalent combination of education, training and experience may be accepted in lieu of degree
Salary/Compensations
- $74,500.00 - $197,500.00
Benefits
- Range of health and welfare and/or other benefits
- Incentive plans
- Bonuses
About the Company
- IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
- We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
- Learn more at https://jobs.iqvia.com
- IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.
- All information and credentials submitted in your application must be truthful and complete.
- Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.
- We appreciate your honesty and professionalism.
Equal Opportunity
- IQVIA is proud to be an equal opportunity employer.
- 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.
- https://jobs.iqvia.com/eoe