In House Clinical Research Associate Job at Lifelancer, South San Francisco, CA

dWRLeThPUUlVb1ZoU3NBUHpad0hCS2hua0E9PQ==
  • Lifelancer
  • South San Francisco, CA

Job Description

Job Description

Job Description

Job Title: In House Clinical Research Associate

Job Location: South San Francisco, CA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Entry level

In House Clinical Research Associate (IHCRA) - REMOTE POSITION

Neurona Therapeutics is an early-stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for neurological diseases. The ideal candidate is a self-motivated individual who has a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and take part in building an exciting, science-driven company.

The inhouse clinical research associate (IHCRA) provides operational support to ensure the effective and efficient delivery of clinical site monitoring on our clinical trials. The IHCRA works with study team and CRO throughout the lifecycle of a study. The IHCRA tracks clinical trial site performance, adequacy of monitoring activities, reviews monitoring visit reports and metrics, and proactively identifies and communicates site management and monitoring issues and risks to the Study Team. The IHCRA verifies the monitoring activities of their assigned study(s) are in accordance with Neurona Therapeutics’ policies and procedures, ICH/GCP, and local regulations. The IHCRA will report directly to the Associate Director, Clinical Operations and Development.

This job is approved for remote work within the United States.

Responsibilities

  • Conduct evidence based feasibility to establish viability of study at potential sites
  • Support study team during the feasibility and site ID process to collect relevant data
  • Develop appropriate site selection and patient retention plans, including the site selection recruitment process
  • Document and track site feasibility progress
  • Ensure Pre-Study Visits occur per established timelines
  • Review Pre-Study Visit Reports
  • Support facilitation of the negotiation of site contracts and budgets
  • Support facilitation of the preparation of documents for ethics committee/other committee submissions (e.g. informed consent form, patient facing materials)
  • Answer site and CRO questions in preparation for submission to ethics/other committee submission
  • Facilitating or scheduling site trainings required per study protocol
  • Development of study start up materials (study plans and templates)
  • Ensure proper training for study sites on required imaging / diagnostic procedures and other diagnostic tools
  • Manage receipt of imaging results in required format
  • Generation of queries related to imaging
  • Central lab management
  • Ensure timely, consistent and quality set up and maintenance of TMF requirements and processes
  • Oversee audits related to TMF activities and processes
  • Management of timely resolution to TMF findings
  • Review and report metrics established for TMF reviews
  • Track TMF deliverables
  • Proactively identifies and communicates site performance and monitoring issues to key stakeholders and implements action plans in conjunction with the study team

Required Qualifications

  • Bachelor’s degree in life sciences or a licensed healthcare professional such as RN or equivalent experience
  • Minimum of 2 years industry experience in related role (site management, study coordinator, in-house CRA)
  • Excellent writing, verbal communication, presentation, and interpersonal skills
  • Able to work within a team environment and take initiative to improve work processes, develop innovative methodologies and approaches to enhance study activities for quality and efficiency
  • Good understanding of ICH/GCP, applicable standards, and FDA regulations for clinical trials
  • Detail oriented with excellent planning and organizational skills
  • Flexibility with changing priorities
  • Good computer skills (MS Office, Google mail, docs and sheets, BOX, Sharepoint, EDC, Veeva, other similar systems)
  • Ability to travel up to 10% nationwide

Preferred Qualifications

  • Experience in cell therapy trials
  • Clinical trial support experience partnering with CROs

This job description is not exhaustive and not intended to cover all activities of the position. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.

Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

Apply on Lifelancer Platform

Job Tags

Full time, Contract work, Local area, Remote job,

Similar Jobs

On Target Utility Services

Fiber Optic Technician Apprentice Job at On Target Utility Services

 ...telecommunications, metering and smart grid services throughout the Northeast. This position is an entry-level position to the Fiber Optic Technician position and will provide support in testing and splicing fiber optic cable including displaying and interpreting results... 

Jobot

Landscape Field Operations Manager (Spanish or Portuguese Speaking) Job at Jobot

 ...associations, and estate landscape maintenance, design, construction, snow and ice management and fence installation solutions. We employee...  ...in weekly scheduling, safety and management meetings. Snow removal & management of snow accounts. Off-season duties including... 

Bankers Life

Entry Level Insurance Sales Agent Job at Bankers Life

 ...Bankers Life seeks professionals for a dynamic hybrid remote work environment. Start your insurance agent career and earn up to $5,000 in bonuses and commissions alone in the...  ...schedule. As an Entry Level Insurance Sales Agent, you will: Schedule appointments... 

iMedX, a Rapid Care Group company

Inpatient Facility Coder Job at iMedX, a Rapid Care Group company

 ...inpatient facility coders. Facility coders worked on behalf of facilities and have...  ...inpatient care. Full-time, part-time, and independent contractor status will be considered. Applicants...  .... This is a remote (work-from-home) position. Purpose: The Medical Coding... 

Sage Dental

Dental Assistant Job at Sage Dental

 ...Job Description Sage Dental is the leading Dental Support Organization (DSO) in the Southeast, and we are continuing to grow! At...  ...for. Overview Sage Dental is seeking a Part-Time Dental Assistant to join our team in Lutz! Our Dental Assistants professionally...