Job details
Job type full-time
Full job description
Great opportunity to join our full-service team in north america! looking for entry level clinical talent to join our team.
Essential functions
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., good clinical practice (gcp) and international conference on harmonization (ich) guidelines.
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 regulationsEscalate 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 resolutionMay support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the trial master file (tmf) verify that the investigator`s site file (isf) is maintained in accordance with gcp / ich 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.
Qualifications
Bachelor`s degree degree in scientific discipline or health care preferredReq
Equivalent combination of education, training and experience may be accepted in lieu of degree.
Some organizations require completion of cra training program or prior monitoring experience.
Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., good clinical practice (gcp) and international conference on harmonization (ich) guidelines).
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).
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.
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 worldThe 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 wayLearn 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, incProvides reasonable accommodations for applicants with disabilitiesApplicants 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 workday_recruiting@iqvia.com to arrange for such an accommodation.
