Senior Principal Clinical Research Associate

November 5

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• 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. • Acts as a site processes specialist, ensuring compliance with protocols and ICH-GCP guidelines. • Monitors investigator sites with a risk-based monitoring approach and applies root cause analysis. • Ensures data accuracy through SDR, SDV and CRF review. • Documents observations in reports and letters in a timely manner using approved business writing standards. • May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed. • Participates in the investigator payment process. • Ensures a shared responsibility with other project team members on issues/findings resolution. • Investigates and follows-up on findings as applicable. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. • Ensures study systems are updated per agreed study conventions. • Performs QC check of reports generated from CTMS system where required. • Identifies potential investigators in collaboration with the client company to ensure compliance. • Initiates clinical trial sites according to the relevant procedures.

Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor) • Valid driver's license where applicable • An equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. • Effective clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Effective interpersonal skills • Strong attention to detail • Effective organizational and time management skills • Ability to remain flexible and adaptable in a wide range of scenarios • Ability to work in a team or independently as required • Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Able to work upright and stationary for typical working hours. • Able to use and learn standard office equipment and technology with proficiency. • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.