Clinical Trial Assistant Job Summary
Responsible for management of Phase II-IV clinical research studies while developing an understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. Manages and oversees study site activities to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines, Standard Operating Procedures (SOPs) and Project Specific Operating Procedures. Job Responsibilities
- Serves as the primary contact for data entry technician.
- Ensure compliance with the protocol requirements, study procedures and relevant guidelines.
- Enter and maintains up-to-date information within the deployed Clinical Trial Management System (CTMS).
- Maintains timely and effective communication among team members and site staff, through oral/written correspondence and ensures adequate documentation of each communication.
- Routinely anticipates/identifies and resolves potential issues.
- Assures compliance with applicable regulations, and guidelines, Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs.
- Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan.
- Assures timely completion and submission of Electronic Case Reports Forms (eCRFs) in accordance with study-specific clinical and data management plans.
- Reviews eCRFs completed by sites and assists the site in resolving queries and/or other identified data collection issues.
- Assures timely and accurate completion of Data Clarification Forms.
- Performs review of clinical data listings, as required.
Reporting and Tracking
- Completes and submits visit reports according to SOP/Works Instructions (WI) or Sponsor requirements.
- Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrolment, and SAEs/Endpoints.
- Updates study and patient status information. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from contact to contact.
Education & Qualifications
- Attends clinical monitoring staff meetings and clinical training sessions according to the project communication, monitoring, and/or training plans.
- BA/BS degree in science/health care field or nursing degree, or equivalent combined education and experience required.
- Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred.
- Basic understanding of clinical research fundamentals expected.
- Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines, required.
- Adequate organizational, documentation, and interpersonal skills essential, as well as a willingness to work within a team-oriented environment.
- Excellent command of written and spoken local language, if not English, as well as English required.
- Ability to develop good working relationships via oral communication and good phone etiquette, required.
- Must be proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment, required.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.