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Senior Clinical Research Associate
2 months ago
We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team in the Minnesota, North Dakota/South Dakota area.
Job Purpose:The Senior Clinical Research Associate will be responsible for managing clinical research studies, ensuring compliance with Good Clinical Practice (GCP) and International Council for Harmonization (ICH) guidelines, and maintaining strong relationships with site investigators and staff.
Key Responsibilities:- Develop and maintain site relationships, ensuring continuity throughout all phases of the trial.
- Perform clinical study site management/monitoring activities, including remote and on-site monitoring, to ensure data accuracy and subject safety.
- Coordinate and manage various tasks with sponsor roles to achieve Site Ready status.
- Participate in site selection and validation activities, and conduct site visits, including validation visits, initiation visits, monitoring visits, closeout visits, and record visit and non-visit contact reports.
- Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and close-out.
- Communicate with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
- Identify, assess, and resolve site performance, quality, or compliance problems, and escalate as necessary.
- Manage and maintain information and documentation in Clinical Trial Management System, Electronic Trial Master File, and other systems as appropriate.
- Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO.
- Fluent in local languages and English (verbal and written) and excellent communication skills.
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH, and country clinical research law and guidelines.
- Hands-on knowledge of Good Documentation Practices.
- Ability to mentor/lead, and perform co-monitoring visits as necessary.
- Effective time management, organizational, and interpersonal skills, conflict management, problem-solving skills, and ability to work independently.
- Ability to travel domestically and internationally approximately 65%-75% of working time.
- Bachelor's degree with a strong emphasis in science and/or biology.
- Experience with conducting site motivational visits to boost site enrollment.
- Ability to understand and analyze data/metrics and act appropriately.
Parexel FSP offers a competitive salary, benefits package, and opportunities for professional growth and development.
We are an equal opportunities employer and welcome applications from diverse candidates.
