Thermo Fisher Scientific Inc.
Location
Burnaby, BC | Canada
Job description
Description
pbu
Job Description/u/b/pp/pp
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.
With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. /pp/pp
Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies./pp/pp/ppb
Position:/b CRA I or II/ppb
Location:/b Vancouver, CAN- REMOTE Employee/pp/ph2/h2h2A day in the Life:/h2ulliMonitors 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 and decrease risks./lili
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. /lili
Assess investigational product through physical inventory and records review. /lili
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 follow all issues through to resolution. /lili
May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner./lili
Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution./lili
Investigates and follows-up on findings as applicable./lili
Participates in investigator meetings as necessary./lili
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, making recommendations where warranted./lili
Performs trial close out and retrieval of trial materials./lili
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. /lili
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)./lili
Responds to company, client and applicable regulatory requirements/audits/inspections. /lili
Maintains completes administrative tasks such as expense reports and timesheets in a timely manner./lili
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members./lili
Contributes to other project work and initiatives for process improvement, as required./li/ulh2/h2h2bEducation/b/h2ulliBachelors degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification./li/ulh2bExperience/b/h2ulliPrevious experience that provides the knowledge, skills, and abilities to perform the job (at least 6-12 Months of Research experience).Valid drivers license where applicable./lili
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./li/ulh2/h2h2bKnowledge, Skills, Abilities/b/h2ulliEffective Research skills, strong experience working within a Research setting, ideally at least 6-12 Months specifically in a Clinical Research environment/lili
Excellent understanding and demonstrated application of FDA guidelines, ICH GCPs, applicable regulations and procedural documents/lili
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving./lili
Understanding of Clinical Monitoring concepts and processes/lili
Ability to evaluate medical research data and proficient knowledge of medical terminology/lili
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel/lili
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues/lili
Excellent interpersonal skills/lili
Strong attention to detail/lili
Effective organizational and time management skills/lili
Ability to remain flexible and adaptable in a wide range of scenarios/lili
Excellent team player with team-building skills/lili
Ability to work independently as required/lili
Ability to utilize problem-solving techniques applicable to constantly changing environment/lili
Strong computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software/lili
Must be proficient with the English language and have strong grammar skills/lili
Effective presentation skills/li/ulh2/h2h2bWork Environment/b/h2pThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working spanenvironment/requirements/span for this role:/pulli
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner./lili
Able to work upright and stationary for typical working hours./lili
Able to work in non-traditional work environments./lili
Able to use and learn standard office equipment and technology with proficiency./lili
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities./lili
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments./lilib
This role requires independent travel, which may range from: 60-80%, inclusive of traveling in automobiles, airplanes, and trains./b/lilib
As a condition to work onsite at some clients, proof of the COVID vaccination may be required./b/li/ulp/pp/pp#CRAdrive/pp
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. /ph2/h2h2Apply today! span Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /ph2/h2h2spanAccessibility/Disability/span Access/h2pJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process.
For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
/pp*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. /pp/pp/ppbr / /pp/p
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