Clinical Research Associate II (CRA II) - FSP Business Unit

h3Work Schedule /h3 pStandard (Mon-Fri) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 pJoin Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation /p pWe 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. /p pAs part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), 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. /p h3What You’ll Do: /h3 ul liMonitors 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. Ensures 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. 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. /li liParticipates in investigator meetings as necessary. Identifies potential /li liinvestigators 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. Performs trial close out and retrieval of trial materials. /li liEnsures 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. /li liProvides 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). /li liFacilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. /li liResponds to company, client and applicable regulatory requirements/audits/inspections. /li liMaintains completes administrative tasks such as expense reports and timesheets in a timely manner. /li liContributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. /li liContributes to other project work and initiatives for process improvement, as required. /li /ul h3Education and Experience Requirements: /h3 ul liBachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. /li liPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. /li liValid driver's license where applicable. /li /ul pIn 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. /p h3Knowledge, Skills and Abilities: /h3 ul liProven clinical monitoring skills /li liDemonstrated understanding of medical/therapeutic area knowledge and medical terminology /li liDemonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents /li liWell-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving /li liAbility to manage Risk Based Monitoring concepts and processes /li liGood oral and written communication skills, with the ability to communicate effectively with medical personnel /li liAbility to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues /li liGood organizational and time management skills /li liEffective interpersonal skills /li liAttention to detail /li liAbility to remain flexibile and adaptable in a wide range of scenarios /li liAbility to work in a team or independently as required /li liGood computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software /li liGood English language and grammar skills /li liGood presentation skills /li /ul h3Working Conditions and Environment: /h3 ul liWork is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. /li liFrequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. /li liExposure to biological fluids with potential exposure to infectious organisms. /li liPersonal protective equipment required such as protective eyewear, garments and gloves. /li liExposure to fluctuating and/or extreme temperatures on rare occasions /li /ul pThermo 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. /p #J-18808-Ljbffr