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Clinical Research Associate

  • Location: Los Altos
  • Salary: US$100000.00 - US$120000.00 per annum per year
  • Job Type:Permanent

Posted 12 months ago

  • Sector: Careers at Hydrogen
  • Contact: Rebecca Keathley
  • Expiry Date: 08 April 2023
  • Job Ref: JN -022023-477510

Clinical Research Associate (In-House)

As a Clinical Research Associate, your presence in our SF Bay Area office is critical to developing culture, maintaining accountability, and overseeing the day-to-day operations of the clinical team. You will report to a Clinical Trial Manager (CTM) and the Director of Clinical

Operations. You will help with the execution and maintenance of our clinical studies according to ICH and GCP standards.

This role is geared toward an individual who understands the fast-paced clinical environment, does not require definition to be effective, and spots issues and dives in. His/her key responsibilities include:

* Develop a strong understanding of our clinical study protocols

* Collaborate closely with clinical research sites to ensure adherence to study protocols and terms

of the studies

* Drive clinical sites to maintain the EDC on a timely basis and collaborate with field based CRAs to

query and assist in accurate data management

* Collect screening logs from sites and work to assist in enrollment challenges

* Maintain, update, and, when required, establish databases for clinical activity tracking

* Track incoming and outgoing clinical and regulatory documents and updates for investigator sites

* Assist CTA with maintaining the electronic Trial Master File (eTMF) following the Drug

Information Association's reference model and periodically reviews (QCs) to ensure accuracy and

completeness

* Monitor subjects through their journey to ensure successful enrollments, randomization and

treatment according to the protocol

* Coordinate clinical study training when appropriate with the Clinical Trial Manager and field based CRAs

* In collaboration with the clinical study team, responsible for tracking, filing, and follow up of SAEs

with clinical sites promptly, per the Safety Management Plan

* Prepare for CRA, Study Coordinator, or Investigator Meetings, as needed, including scheduling,

tracking, preparation and creating, distributing, and filing of meeting minutes

* Maintain tracking information for study activities, including site qualification, site activation, site

initiation, interim monitoring, and close-out visits

* Assist in audits and inspections to ensure data is available and clean

* Ensure site IRB statuses are current and the CTM is notified of changes to 1572s, site contacts and other critical contacts

* Other assignments may be added in the future

All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company's Standard Operating Procedures. This is an opportunity for an experienced CRA/CTA position to have the opportunity to function at a higher level with mentorship in a fast-paced start-up environment.

REQUIRED EDUCATION:

* Bachelor's degree

DESIRED EXPERIENCE:

* Minimum of 2 years of experience as a CRA/CTA

* Experience working on oncology clinical trials is preferred

* Experience working on Phase 2/3 oncology clinical trials

* Energetic, forward-thinking, and creative with high ethical standards and good judgment

* Analytical, technical, and project management skills with the ability to work well under pressure

and time constraints from competing priorities

* Possess the ability to see the larger picture perspective while being well-versed in different

aspects of the company

* Resourceful, strategic, and analytical thinker who can help shape the future strategy of the

company, anticipate potential challenges, and develop viable options to ensure successful

outcomes

* Highly developed cross-functional collaboration and planning capabilities

* Detail-oriented with a high degree of accuracy and exactitude; ability to successfully lead and

complete projects with multiple stakeholders

* Excellent interpersonal, analytical, and leadership skills

* Highly proficient with Microsoft Office applications (Outlook, Word, Excel, and PowerPoint)

...