Enter a job title or keyword

Sr. Clinical Research Associate (US)

Alimentiv

Job Location:

San Francisco, CA - USA

Yearly Salary: $ 86000 - 143000

Posted: 7 August 2026 (3 days ago)

Application Deadline: 4 November 2026

Vacancies: 1 Vacancy

Job Summary

Independently performs coordinates and oversees all aspects of the clinical site monitoring services assessing protocol and regulatory compliance as per Alimentivs and sponsors standard processes ICH/GCP guidelines and local regulation. Serves as the primary liaison between the sponsor/Alimentiv and investigative sites by playing a critical role in the execution of clinical study plans. Provides guidance and mentoring CRA I and II collaborating effectively with cross-functional stakeholders in a dynamic results-driven and high-accountability environment. Perform CRA Assessment Visits and participate in audits/inspections when required.

Site Monitoring activities (55-60%)

Independently conduct and document onsite and remote activities including site monitoring and close-out visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance.
Collaborate with site staff to review and ensure that the data reported in the applicable study system(s) is consistent with the source documents and compliant with study requirements.
Monitor resolve and/or facilitate resolution of data queries and escalate issues as appropriate.
Coordinate the shipment of clinical supplies including but not limited to investigational product laboratory supplies ePROs and study documents.
Ensures site staff is trained in all aspects of the study including but not limited to the protocol study plans systems and ICH-GCP.
Participate in routine study progress meetings teleconferences and Investigators meetings.
Routinely review ISF and TMF for accuracy timeliness and completeness. Request documents from the site as required.

Site Management activities (15-20%)

Act as a primary contact for any questions or issues that arise from investigational sites.
Oversee overall integrity of the study and promote positive working relationships with the site staff and study team members.
Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.
Ensure all site related issues are followed until resolution including action items and protocol deviations.
Coordinate delivery of clinical sites communications collaborating with project teams to ensure investigational sites are provided accurate ongoing data updates information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.
Regularly review the study related systems remotely to ensure compliance accuracy and completeness.
Translate site documents for TMF filing when applicable.
Routinely review the TMF for accuracy timeliness and completeness. Request documents from the site as required.
Coordinate the shipment of clinical supplies including but not limited to investigational product laboratory supplies ePROs and study documents.
Participate in audits/inspections and follow-up on issues and implement actions when required.
Participate in routine study progress meetings and teleconferences.

Site Recruitment and Setup (15-20%)

Identify and advise on site investigators selection independently conduct and document onsite and remote activities including site qualification and initiation visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance.
Coordinate the shipment and delivery of clinical supplies including but not limited to laboratory supplies study documents and investigational product.
Responsible for all site management activities related to site activation and work with the sites to meet clinical project timelines and milestones.
Support the study Start-up team by following up on pending documents as needed.
Support the Regulatory team by reviewing localizing and translating site documents as required.
Optimize patient recruitment providing guidance and support to site teams to meet the site recruitment milestones.
Participate in Investigators meetings.

Mentoring and Internal Initiatives (5-10%)

Mentor and support CRA I and II.

Perform CRA Assessment Visits co-monitoring visits or visit sign-off process providing feedback.
Assist the MSM hiring Manager by participating in interviews with candidates for the CRA position as requested.
Participate in process improvement initiatives and contribute to the development of best practices.

Qualifications

The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience.
Ability to regularly travel to sites.
Proficient in using EDC systems (e.g. Medidata Rave Oracle InForm) IRT eTMF CTMS and Microsoft Office Suite.
Ability to travel up to 40-60% depending on project assignment and geographic location of sites.
Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams.
Great communication and organizational skills detailed orientation and sense of urgency are required.

Working Conditions

Home-based
Regular travel is required

$86000 - $143000 a year

bonus

Stay Alert to Recruitment Scams
We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesnt feel right we encourage you to verify before responding.

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

Senior IC

Apply Now