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Senior Clinical Research Associate I/II
Location
Norway
Posted
1 day ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Senior Clinical Research Associate I/II
Thermo Fisher Scientific
Role Description Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at the Forefront of Innovation. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. - Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. - Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). - Ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs. - 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 You’ll Do: - Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills. - Ensure data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities. - Assess investigational product through physical inventory and records review. - Document observations in reports and letters in a timely manner using approved business writing standards. - Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. - Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence and issue resolution. - Conduct monitoring tasks in accordance with the approved monitoring plan. - Participate in the investigator payment process. - Ensure shared responsibility with other project team members on issues/findings resolution. - Investigate and follow-up on findings as applicable. - Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. - Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System, CTMS). - Perform QC check of reports generated from CTMS system where required. - Participate in investigator meetings as necessary. - Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. - Initiate clinical trial sites according to relevant procedures to ensure compliance with protocol and regulatory obligations. - Ensure trial close out and retrieval of trial materials. - Ensure that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. - Conduct on-site file reviews as per project specifications. - Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. - Perform additional study tasks as assigned by CTM (e.g., trip report review, newsletter creation, lead CRA team calls, etc.). - Facilitate effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts. - Respond to company, client, and applicable regulatory requirements/audits/inspections. - Maintain & complete administrative tasks such as expense reports and timesheets in a timely manner. - Contribute to other project work and initiatives for process improvement, as required. Qualifications - Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification. - Total experience: at least 3 years as a CRA. - Oncology/Cell therapy experience: at least 2 years of on-site, hands-on experience. - Location: various locations. Requirements - 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. Working Conditions and Environment - Work is performed in an office/laboratory/clinical/and/or home office environment with exposure to electrical office equipment. - Frequent drives to site locations. - Frequent travel, generally 60-80% but more for some individuals. - May also include extended overnight stays. - Exposure to biological fluids with potential exposure to infectious organisms. - Personal protective equipment required such as protective eyewear, garments, and gloves. - Exposure to fluctuating and/or extreme temperatures on rare occasions. - Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific.
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