Sr Clinical Research Associate

Position Details:

Role: Sr Clinical Research Associate

Location: Remote – 80% travel required

Duration: 6 months with possible extension

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.

About Mindlance:

Advance your career with Mindlance! We have been connecting talented IT professionals with world-class companies since 1999. Mindlance is here to help you to find the perfect fit with just the right company. Currently, we are seeking an Operational Analyst for an exciting career growth opportunity.

Make your next big career move with the kind of position that will allow you to be genuinely passionate about the work you do! Our recruiters will work closely with you to help you get the edge over the competition. Let Mindlance advocate for you – apply today!

EEO:

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