Clinical Research Associate

Novotech Global•South San Francisco, CA

7h•$70,000 - $110,000

About The Position

The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

Requirements

Approximately 1-2 years of Clinical Research Associate experience or equivalent experience (CRA II fast track) in other roles in the Clinical industry.
Fully competent and productive and can perform the full range of responsibilities within the Regulatory Start-Up function.
Works with a high degree of autonomy.

Responsibilities

CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
Responsible for learning the company culture, policies, and procedures through specialized training called CRA II fast track training program including observational visits for all types of visits (if applicable) and on the job training by supporting the day-to-day CRA activities of clinical project team members such as CRAs and Line managers (LMs).
Responsible for quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.
Provide mentorship to junior staff and can also provide support to the line manager or project manager as per request.
Responsible for quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.