Senior Clinical Research Associate

Position Details:

Job Title:

Clinical Research Associate

Duration: 06+ months with possible extension

Location: Remote (California, Nevada, Colorado, Arizona, Utah)

Summarized Purpose:

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Key Responsibilities:

• Conduct remote and on-site monitoring visits to assess protocol and regulatory compliance.
• Manage required clinical trial documentation and ensure audit readiness.
• Apply a risk-based monitoring approach, including root cause analysis, critical thinking, and problem-solving.
• Perform SDR, SDV, and CRF reviews as applicable to ensure data accuracy.
• Review investigational product inventory and related records.
• Identify, document, and escalate site deficiencies and issues through resolution.
• Maintain regular communication with investigative sites to ensure protocol compliance and timely data recording.
• Monitor trial activities according to the approved monitoring plan.
• Identify potential trends across sites and discuss appropriate management strategies with the Clinical Team Manager.
• Support investigator identification, site initiation, and trial close-out activities.
• Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations.
• Participate in file reviews, investigator meetings, training, mentoring, and process improvement activities.
• Maintain study systems such as CTMS and provide trial status and progress updates.
• Support effective communication between investigative sites, the client, and the project team.
• Respond to regulatory requirements, audits, and inspections.
• Complete administrative activities, including expense reports and timesheets, in a timely manner.

Requirements:

• Bachelor’s degree in a life science-related field, Registered Nursing certification, or equivalent relevant qualification.
• 3+ years of clinical research monitoring experience or comparable relevant experience.
• Valid driver’s license where applicable.
• Strong knowledge and application of FDA guidelines, ICH-GCP, applicable regulations, and procedural requirements.
• Experience with risk-based monitoring, root cause analysis, and problem-solving.
• Strong clinical monitoring, organizational, communication, and interpersonal skills.
• Ability to evaluate medical research data and knowledge of medical terminology.
• Strong attention to detail and ability to manage changing priorities.
• Ability to work independently and effectively as part of a team.
• Proficiency with Microsoft Office and ability to learn applicable clinical systems.
• Strong English communication and presentation skills.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”