Clinical Trial Assistant (contract)
Clinical Operations | Berkeley, CA | Part Time and Contract
Plexxikon, a member of the Daiichi Sankyo Group, is a leader in the discovery and development of novel, small molecule pharmaceuticals. The company utilizes its proprietary discovery platform to successfully develop a portfolio of competitively differentiated clinical and preclinical stage compounds in a number of therapeutic areas. Plexxikon’s first marketed drug, Zelboraf™ (vemurafenib) was the first precision medicine to be approved for the treatment of BRAF-mutant metastatic melanoma. Plexxikon's demonstrated capability in discovery and early development uniquely positions the company to develop multiple commercial franchises for different therapeutic indications, and to create significant value for Plexxikon, Daiichi Sankyo and its collaborators. Plexxikon's novel discovery approach, combined with experienced management and scientific teams, a broad network of scientific and clinical experts, and partnerships supporting later stage development, have been key drivers of the company's success since it began operations in 2001. Plexxikon is a small business with approximately 65 employees based in Berkeley, California.
The contract Clinical Trial Assistant (CTA) is responsible for providing logistical support for one or more clinical trials throughout study start-up, conduct, and close-out and supporting the clinical team. This is an exceptional opportunity to get hands-on clinical operations experience in a successful biotechnology company. You will be payrolled through a partner agency, but will be working for Plexxikon.
Responsibilities include, but are not limited to:
- With guidance from the clinical team, communicates with Contract Research Organization (CRO), other clinical vendors, and sites regarding clinical trial start-up, conduct, and close-out activities
- Assists with collection and review of regulatory document packages from clinical sites in start-up
- Organizes, reviews for completeness, reconciles findings with CRO, and archives Trial Master Files
- Maintains internal clinical document archive (interim TMF document repository, Vendor Files, etc.)
- Maintains tracking systems and tools to support the conduct of clinical studies (e.g., clinical study log, clinical site log, protocol/investigator’s brochure/informed consent form trackers, budget and invoice trackers)
- Manages Investigational Product shipment requests and distribution of other clinical study materials to and from clinical sites
- Coordinates meeting planning and execution, including assembly of meeting materials, scheduling/invitations, and recording minutes
- Collects and distributes monthly clinical study dashboards to management
- Assists Clinical Program Manager, Clinical Research Associate, and Medical Monitor with the development of study specific plans and processes
- Interacts with Quality Assurance, Regulatory Affairs, Clinical Supplies Management, Legal, Finance, Information Technology, and Research as needed to support clinical studies
- Coordinates updates of www.clinicaltrials.gov for Plexxikon-sponsored clinical studies
Position Requirements & Experience:
- Bachelor's degree in life science, nursing, or related field, with experience in clinical research or healthcare related industry preferred; or equivalent combination of education and experience
- Familiarity with FDA regulations and ICH/GCP experience preferred
- Microsoft Office Suite and proficient computer skills across multiple applications
- Prioritizes and multitasks to ensure that assignments are completed on time
- Detail and team oriented with excellent cross-functional team participation skills
- Desire to learn and tackle new challenges is imperative
- Excellent interpersonal, verbal and written communication skills
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Ability to work from home 100% through at least mid-2021 due to COVID-19 (e.g., broadband internet, telephone, printer/scanner access; Plexxikon will provide laptop, external monitor)
- No travel in first half of 2021; may require up to 10% travel when COVID-related restrictions are lifted
- Candidates must be authorized to work in the U.S.
Plexxikon is located in Berkeley, just off interstate 80. We offer a chance to work with talented people in a collaborative environment. As an equal opportunity employer, Plexxikon is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
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