Join Us as a Clinical Research Associate I – Make an Impact at the Forefront of InnovationWe 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, you’ll have the opportunity to perform and coordinate different aspects of the clinical monitoring and site management process. As a Clinical Research Associate 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 -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 You’ll Do:Monitors 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 maintat 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.Participates in investigator meetings as necessary.May help to identify 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 materials.Ensures that required essential documents are complete and ording to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.Provides trial status tracking and progress update reports to the team as required.Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts.Responds to company, client and applicable regulatory requirements/audits/inspections.Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.Contributes to other project work and initiatives for process improvement, as required.Education and Experience Requirements:Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained ical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.Valid driver's license where applicable.Must be legally authorized to work in the United States without sponsorship.Must be able to pass a comprehensive background check, including a drug screening.Candidates ideally live within 60 miles of a major airport hub.Knowledge, Skills and Abilities:Basic medical/therapeutic area knowledge and understanding of medical terminologyAbility to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documentsGood oral and written communication skills, with the ability to communicate effectively with medical personnelGood interpersonal skillsAbility to maintaention to detail and the ability to perceive customers’ underlying issuesGood organizational and time management skillsAbility to remain flexibile and adaptable in a wide range of scenariosWell-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 processesAbility 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 skillsWorking 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.Compensation and BenefitsThe salary pay range estimated for this position CRA (Level I) based in North Carolina is $75,000.00–$89,000.00.This 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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: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 discountFor more information on our benefits, please visit:
https://jobs.thermofisher.com/global/en/total-rewards
5 days ago