Proclinical is currently looking for a Clinical Study Assistant II for its client located in Jacksonville, FL. Successful candidate will support the overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with clinical trial team members and investigative sites.
- Support investigative sites toward completion of all required clinical trial documents prior to site initiation.
- Create the regulatory binder with the requested essential documents collected for each clinical site assigned to a study.
- Assist clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site and internally throughout the duration of assigned trials.
- Enter and maintain required documentation in study specific databases related to purchases, contracts, health care compliance, study document management, and other areas as required.
- Responsible for the set-up of the Trial Master File, investigator study file binders and regulatory document collection.
- Finalize and review clinical trial protocols, investigator brochures, and clinical study reports as the last review.
- Assist with interdepartmental project teams as a central point of contact in the creation of contracts and submit contracts for health care professionals through universities and clinical sites in and/or outside the United States.
- Follow the contract through lifecycle with potential amendments.
- Adhere to guidelines of investigator and consultant payments within the Fair Market Value ranges per activity.
- Create the budget and set up Purchase Order and/or Check Requisition for the payment to clinical research sites and/or third parties as needed.
- Interact with internal and external personnel involved in clinical research, including investigative site personnel, as appropriate.
- Support the successful execution of assigned studies in conformance with global regulations and internal policies and procedures.
Skills and Requirements:
- BA/BS or higher from an accredited institution and 1-2 years' Clinical Study Assistant, or 3+ years' related experience.
- Strong organizational skills and attention to detail
- Proficient in Microsoft Office.
- Ability to work with minimal supervision in a Team environment.
- The ability to understand written work instructions and follow the requirements.
- Fluent in English both verbally as well as with reading and writing skills.
- Good communication via written, verbal and listening skills.
- Ability to report to corporate offices for routine, daily work.
- Knowledge of FDA guidelines, regulations and/or Good Clinical Practice a strong plus.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Maya Smith at (+1) Phone number blocked - click to apply or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
BA/BS or higher from an accredited institution and 1-2 years' Clinical Study Assistant, or 3+ years' related experience.
Strong organizational skills and attention to detail
Proficient in Microsoft Office.
Ability to work with minimal supervision in a Team environment.
The ability to understand written work instructions and follow the requirements.
Fluent in English both verbally as well as with reading and writing skills.
Good communication via written, verbal and listening skills.
Ability to report to corporate offices for routine, daily work.
Knowledge of FDA guidelines, regulations and/or Good Clinical Practice a strong plus.
Clinical Study Reports
Trial Master File
Good Clinical Practices (Gcp)
Attention To Detail