What are the responsibilities and job description for the Clinical Trial Associate position at May Health?

Position Summary

The Clinical Trial Associate will ensure clinical trials are supported in accordance with all applicable regulatory requirements. This is a hybrid position; some days are office-based, and some days can be worked remotely from a home office. Candidates must reside in the San Francisco Bay area and be willing and able to commute to the Menlo Park office.

Responsibilities

Major Responsibilities :

Maintain electronic Trial Master File (eTMF) study documentation to ensure audit-readiness.
Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases.
Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal audits to ensure all essential eTMF documents are compliant with Good Documentation Practices, internal SOPs, US regulations and study documents.
Support study start-up, conduct and close-out activities including essential document review, creating study specific essential document lists, managing and communicating the status of study progress and activities.
Assess current processes, identify opportunities, and propose solutions to improve process efficiency within and across related functional areas.
Partner with the cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution.
Contact clinical sites for specific requests (e.g. enrollment updates, missing documentation, data entry timelines, data query follow-up, action item resolution, etc.)
Regularly attend and provide study updates in team meetings.
Other incidental duties.

Compliance & Legal Responsibilities

Maintaining the highest standards of ethics in all circumstances

Ensuring respect of Good Clinical Practices and General Data Protection Regulation

Ensuring compliance with the Company quality system and all applicable guidance, standards and regulations.

Position Requirements

Necessary skills and experience :

Bachelor’s Degree

Minimum of 3 years of Sponsor clinical research experience supporting regulated clinical research studies particularly during site and study start-up and ideally involving investigational medical devices.

Excellent planning, organizing, problem-solving, and execution skills with the ability to appropriately initiate and escalate.

Experience working in various sized organizations, including a start-up environment.

Good computer skills in usage of MS Office Suite and Clinical Systems such as eTMF (electronic Trial Master file) and Electronic Data Capture (EDC) preferred.

Excellent written and verbal communication skills and interpersonal relationship skills

Excellent problem-solving and critical thinking skills

Solid understanding of regulatory submissions, reporting, and audits

Ability to manage confidential information with discretion

Strict attention to detail and personal accountability

Ability to manage competing priorities in a fast-paced environment

Must be able to work in a team environment, including inter-departmental teams, and maintain a professional interpersonal relationship with study team, sites, and vendors.

Apply for this job

Receive alerts for other Clinical Trial Associate job openings

Clinical Trial Associate

What are the responsibilities and job description for the Clinical Trial Associate position at May Health?

What is the career path for a Clinical Trial Associate?

Not the job you're looking for? Here are some other Clinical Trial Associate jobs in the Menlo, CA area that may be a better fit.

We don't have any other Clinical Trial Associate jobs in the Menlo, CA area right now.

AI Assistant is available now!