[Remote] Clinical Research Associate II - Oncology, Ophthalmology & Neurology - Central US

Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a leader in healthcare, seeking a Clinical Research Associate II to advance research in oncology, ophthalmology, and neurology. This role involves performing and coordinating clinical monitoring and site management, ensuring compliance with regulations and protocols, and fostering relationships with investigational sites.ResponsibilitiesMonitors 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 applicableParticipates 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. Performs trial close out and retrieval of trial materialsEnsures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specificationsProvides 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)Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contactsResponds to company, client and applicable regulatory requirements/audits/inspectionsMaintains & completes administrative tasks such as expense reports and timesheets in a timely mannerContributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team membersContributes to other project work and initiatives for process improvement, as requiredSkillsBachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualificationPrevious 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 FellowshipValid driver's license where applicableProven clinical monitoring skillsDemonstrated understanding of medical/therapeutic area knowledge and medical terminologyDemonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documentsWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solvingAbility to manage Risk Based Monitoring concepts and processesGood oral and written communication skills, with the ability to communicate effectively with medical personnelAbility to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issuesGood organizational and time management skillsEffective interpersonal skillsAttention to detailAbility to remain flexible and adaptable in a wide range of scenariosAbility to work in a team or independently as requiredGood computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate softwareGood English language and grammar skillsGood presentation skillsBenefitsThis position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.A choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountCompany OverviewThermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services. It was founded in 1956, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 10001+ employees. Its website is https://www.thermofisher.com.