Clinical Trial Assistant/Sr. Clinical Trial Assistant - CTA; Remote – PST
Position: Clinical Trial Assistant/Sr. Clinical Trial Assistant - CTA (Remote – PST Based Required) Location: California We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Trial Assistant (CTA) in California. The Clinical Trial Assistant (CTA) provides support to the Project Manager and clinical study team. Assist clinical research studies by providing project administration and project tracking support. The CTA will interface with the study team and may act as a central point of contact for designated study tasks.
- Full Time Hours (Monday through Friday)
- Remote/Virtual (MUST BE LOCATED IN PACIFIC TIME ZONE – PST)
Responsibilities
- Track and maintain study information
- Report on the progress of clinical trials as assigned
- Assist with the creation of critical study documents (ICFs, study reference documents, study newsletters, site material, and other related documents)
- Aid in the collection and tracking of documents during site start-up
- Review study-specific regulatory document packets prior to site activation
- Submit documents to and maintain the TMF
- Coordinate the review of the eTMF to ensure inspection-readiness at all times
- Prepare and distribute agenda, minutes, and action items for internal/external teams
- Update TMF, CTMS, IMP management systems, etc., when needed
- Support preparation activities for FDA, other regulatory body meetings/inspections, and internal audits
- Participate in SOP and/or internal template development/review
- Join in on vendor management activities
Experience
- Minimum of 2 years of CTA experience in the coordination of Phase I to III clinical trials required
- Experience working within a pharmaceutical sponsor, biotech, or CRO organization is required. Not looking for only academic research experience for this role.
- Previous Oncology experience preferred. Please list therapeutic areas on your resume.
- Experience with in ICH, GCP, and FDA guidelines
EDUCATION Minimum of a Bachelor’s Degree in life sciences or a relevant field preferred About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services, including CRO, Functional Support, Quality and Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent and Client, visit Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available. #J-18808-Ljbffr Apply tot his job Apply To this Job