Thermo Fisher Scientific
Sr Clinical Research Associate (CRA)/Principal CRA - West
Thermo Fisher Scientific, Las Vegas, Nevada, us, 89105
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
A day in the Life:
Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions. Ensures data accuracy through SDR, SDV and CRF review. Conducts monitoring tasks in accordance with the approved monitoring plan.
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.
Participates in investigator meetings as necessary. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory obligations.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
Contributes to the project team by assisting in preparation of project publications/tools, and performing additional study tasks as assigned by CTM.
Facilitates effective communication between investigative sites, the client company and the PPD project team.
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 in a life sciences related field or a Registered Nursing certification or equivalent.
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.
Knowledge, Skills and Abilities:
Effective clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including root cause analysis and problem-solving
Effective oral and written communication skills
Strong attention to detail and effective organizational skills
Ability to work in a team or independently as required
Good computer skills: proficient knowledge of Microsoft Office
Good English language and grammar skills
Work Environment:
Able to communicate and understand information with diverse groups of people.
Able to work upright and stationary for typical working hours.
Able to perform successfully under pressure while prioritizing multiple projects.
This role requires independent travel up to 80%.
Compensation and Benefits
The salary range estimated for this position is $90,000 annually - $157,000 annually. This position will also be eligible to receive a variable annual bonus based on company performance. We offer a comprehensive Total Rewards package that includes:
A choice of national medical and dental plans, and a national vision plan
Employee assistance program
Paid time off (PTO), paid parental leave, accident and life insurance, and short- and long-term disability
Retirement and savings programs, such as our competitive 401(k)
Apply today!
http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer.
#J-18808-Ljbffr
Standard (Mon-Fri)
Environmental Conditions
Office
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.
A day in the Life:
Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions. Ensures data accuracy through SDR, SDV and CRF review. Conducts monitoring tasks in accordance with the approved monitoring plan.
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.
Participates in investigator meetings as necessary. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory obligations.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
Contributes to the project team by assisting in preparation of project publications/tools, and performing additional study tasks as assigned by CTM.
Facilitates effective communication between investigative sites, the client company and the PPD project team.
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 in a life sciences related field or a Registered Nursing certification or equivalent.
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.
Knowledge, Skills and Abilities:
Effective clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including root cause analysis and problem-solving
Effective oral and written communication skills
Strong attention to detail and effective organizational skills
Ability to work in a team or independently as required
Good computer skills: proficient knowledge of Microsoft Office
Good English language and grammar skills
Work Environment:
Able to communicate and understand information with diverse groups of people.
Able to work upright and stationary for typical working hours.
Able to perform successfully under pressure while prioritizing multiple projects.
This role requires independent travel up to 80%.
Compensation and Benefits
The salary range estimated for this position is $90,000 annually - $157,000 annually. This position will also be eligible to receive a variable annual bonus based on company performance. We offer a comprehensive Total Rewards package that includes:
A choice of national medical and dental plans, and a national vision plan
Employee assistance program
Paid time off (PTO), paid parental leave, accident and life insurance, and short- and long-term disability
Retirement and savings programs, such as our competitive 401(k)
Apply today!
http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer.
#J-18808-Ljbffr