Senior Clinical Research Associate

Location: Center Valley

** Working

Location:

Nationwide*
* ** Workplace Flexibility:
Remote*
* ** _For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. ​_*
* ** _​_*
* ​

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our

Purpose:

** Patient Focus, Integrity, Innovation, Impact and Empathy.*
* Learn more about Life at Olympus:
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** Job Description*
* The Clinical Research Associate (CRA) III is responsible for conducting the day-to-day management of activities associated with the execution and monitoring of clinical trials. The CRA III ensures that clinical tasks are being performed in compliance with applicable regulatory standards, ICH-GCP Guidelines, and all applicable regulatory requirements and company policies and procedures.

** Job Duties*
* + Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) in compliance with the study-specific Clinical Monitoring Plan, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable government regulations and guidelines.

+ Participate in developing clinical study monitoring plans, study protocols, informed consent forms, case report forms, clinical study reports, and other key study-specific deliverables.

+ Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and reports.

+ Provide regular updates on study progression; proactively identify and resolve issues that arise during study conduct; and manage escalation of study-related issues to the Clinical Project Manager and/or the Global Lead.

+ Work on site qualification assessments and selection of countries and sites for study conduct.

+ Participate in and may facilitate cross-functional study teams, liaising with other functional areas to accurately coordinate clinical study activities.

+ Assist in the development of appropriate Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure compliance with ICH-GCP guidelines and company SOPs/WIs for clinical studies.

+ Create and conduct training sessions, including investigator meetings and site training programs.

+ Participate in study audits, as applicable, including providing guidance at the site and project levels toward audit readiness standards and supporting preparation for audits and required follow-up actions.

+ Coordinate with Regulatory Affairs and Medical Safety teams to track and monitor the reporting of adverse events, including conducting risk assessments, mitigation activities, and contingency planning as required.

+ Oversee and support Clinical Research Associates (CRAs) throughout the study lifecycle, from site identification through study close-out.

+ Collaborate with sponsor affiliates and key opinion leaders (KOLs).

+ Mentor and train junior members of the clinical team.

+ Participate in preparing vendor requirements, defining project scope, and selecting study vendors; effectively manage interactions with vendor study teams.

+ Review monitoring visit reports and collaborate with other CRAs and/or Monitors to identify quality trends or site issues and develop appropriate solutions.

** Job Qualifications*
* *
* Required:

*
* + BA/BS or equivalent experience in scientific or healthcare disciplines.

+ Minimum of five (5) or more years' experience in clinical research, with medical device and/or pharmaceutical trials.

+ Minimum of three (3) or more years' experience in on-site clinical trial monitoring.

+ Strong computer skills with a proficiency with MS Windows based applications.

+ Strong knowledge and understanding of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials which includes applicable ISO regulations for any trials conducted globally.

+ Strong interpersonal, communication and leadership skills

+ Flexibility to accommodate changes in priorities and project needs.

+…