Thermo Fisher Scientific
Sr Clinical Research Associate (CRA)/Principal CRA - West
Thermo Fisher Scientific, New York, New York, United States,
Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
This position requires overnight travel either regionally or nationally, dependent on business needs.
Discover Impactful Work:
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 that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs. Ensures audit readiness. Develops collaborative relationships with investigational sites.
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
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 (e.g. Clinical Trial Management System, CTMS).
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to other project work and initiatives for process improvement, as required.
Keys to Success:
Education
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Experience:
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.
In some cases, 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.
Knowledge, Skills and Abilities:
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
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
Work Environment:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
Compensation and Benefits
The salary range estimated for this position based in California is $90,000.00–$157,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on.
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Environmental ConditionsOffice
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
This position requires overnight travel either regionally or nationally, dependent on business needs.
Discover Impactful Work:
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 that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs. Ensures audit readiness. Develops collaborative relationships with investigational sites.
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
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 (e.g. Clinical Trial Management System, CTMS).
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to other project work and initiatives for process improvement, as required.
Keys to Success:
Education
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Experience:
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.
In some cases, 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.
Knowledge, Skills and Abilities:
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
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
Work Environment:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
Compensation and Benefits
The salary range estimated for this position based in California is $90,000.00–$157,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on.
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