Experienced Bilingual Clinical Research Associate (CRA II / Senior CRA) - QC/ON Oncology

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Senior Clinical Research Associate (Level I) u2013 Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, youu2019ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate (Level I), you''ll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects'' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What Youu2019ll Do:
u2022 Monitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV andCRF review as applicable through on-site and remote monitoring activities.Assess investigational product through physical inventory and records review. 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. 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. 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. Investigates and follows-up on findings as applicable
u2022 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). Performs QC check of reports generated from CTMS system where required.
u2022 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, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
u2022 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.
u2022 Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
u2022 Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
u2022 Responds to company, client and applicable regulatory requirements/audits/inspections.
u2022 Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
u2022 Contributes to other project work and initiatives for process improvement, as required.
Education and Experience Requirements:
*Required: Neurology/Rare Disease
*Required: Bilingual in French/English
u2022 Bachelor''s degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
u2022 Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
u2022 Valid driver''s license where applicable
u2022 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:
u2022 Effective clinical monitoring skills
u2022 Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
u2022 Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
u2022 Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
u2022 Ability to manages Risk Based Monitoring concepts and processes
u2022 Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
u2022 Ability to maintain customer focus through the utilization of good listening skills, attention to detailand the ability to perceive customersu2019 underlying issues
u2022 Effective interpersonal skills
u2022 Strong attention to detail
u2022 Effective organizational and time management skills
u2022 Ability to remain flexible and adaptable in a wide range of scenarios
u2022 Ability to work in a team or independently as required
u2022 Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
u2022 Good English language and grammar skills
u2022 Good presentation skills
Working Conditions and Environment:
u2022 Working Conditions and Environment:
u2022 Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
u2022 Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals.
u2022 May also include extended overnight stays.
u2022 Exposure to biological fluids with potential exposure to infectious organisms.
u2022 Personal protective equipment required such as protective eyewear, garments and gloves.
u2022 Exposure to fluctuating and/or extreme temperatures on rare occasions.
u2022 Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site.
Thermo 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.