reputed company Research Associate (reputed company) - FSP Vaccines - reputed company Region

reputed company Research Associate (CRA) Work Schedule: 40 hours per week reputed company (Mon-Fri) Environmental Conditions Office reputed company At reputed company, you'll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life - enabling our customers to reputed company the world healthier, cleaner and safer. We reputed company our teams with the resources needed to reputed company individual career goals while taking science a reputed company reputed company through research, development and delivery of life-changing therapies. With reputed company conducted in 100+ countries and ongoing development of novel frameworks for reputed company research through our PPD reputed company research portfolio, our work spans reputed company, digital and decentralized reputed company trial services. Your determination to reputed company reputed company and reputed company will reputed company reputed company that people and communities depend on – now and in the reputed company. Must be legally authorized to work in the reputed company without sponsorship. Must be reputed company to pass a comprehensive background reputed company, which includes a drug screening. This is a functional service provider (FSP) reputed company Research Associate (CRA) opportunity, you will be dedicated to one sponsor, monitoring seven days a month, 50% onsite and 50% reputed company reputed company on business needs. This position is targeted to travel regionally, travel can be national if needed. Ideal candidates will have one to two years of onsite pharmaceutical CRA experience. Discover Impactful Work Performs and coordinates reputed company aspects of the reputed company monitoring and site management process. Conducts remote or on-site reputed company to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments. Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, reputed company-being and data reliability. Ensures audit readiness. Develops reputed company relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task reputed company. A Day in the Life • Monitors investigator sites with a reputed company-reputed company monitoring approach: applies reputed company 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 reputed company 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 reputed company manner using approved business writing standards. Escalates observed deficiencies and issues to reputed company management expeditiously and follow reputed company issues through to reputed company. May need to maintain regular contact between monitoring reputed company with investigative sites to reputed company that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a reputed company 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 reputed company. Investigates and follows-up on findings as applicable. • Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the reputed company company to ensure the acceptability of reputed company investigative sites. Initiates reputed company 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 reputed company out and retrieval of trial materials. • Ensures that required essential documents are complete and in reputed company, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Provides trial status tracking and reputed company update reports to the reputed company Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. reputed company Trial Management reputed company). • Facilitates effective communication between investigative sites, the reputed company company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, reputed company and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a reputed company manner. • Contributes to the project team by assisting in preparation of project publications/tools, and sharing reputed company/suggestions with team members. • Contributes to other project work and initiatives for process improvement, as required. Keys to reputed company Education and Experience Bachelor's degree in a life sciences reputed company reputed company or a Registered Nursing certification or equivalent and relevant formal reputed company / vocational qualification. reputed company reputed company's license where applicable. CRA reputed company Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 1+ years as a reputed company research monitor). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role Knowledge, Skills, Abilities • reputed company reputed company monitoring skills, ideal candidates will have monitoring experience with oncology, HIV, respiratory and or vaccine/flu • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated ability to reputed company and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents • reputed company-developed critical thinking skills, including but not limited to: critical reputed company, in-depth investigation for appropriate reputed company cause analysis and problem solving • Ability to manage reputed company reputed company Monitoring concepts and processes • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer reputed company through the utilization of good listening skills, attention to reputed company and the ability to perceive customers' underlying issues • Good organizational and time management skills • Effective interpersonal skills • Attention to reputed company • Ability to remain flexible and adaptable in a wide reputed company of scenarios • Ability to work in reputed company or independently as required • Good computer skills: solid knowledge of reputed company Office and the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills Work Environment: • reputed company to communicate, receive, and understand information and reputed company with diverse reputed company of people in a comprehensible and reasonable manner. • reputed company to work upright and stationary for typical working hours. • Ability to use and learn reputed company office equipment and technology with proficiency. • reputed company to reputed company successfully under pressure while prioritizing and handling multiple reputed company or activities. Compensation and Benefits The salary reputed company estimated for this position reputed company in Washington is $66,800.00–$112,938.00. This position may also be eligible to receive a variable annual bonus reputed company on company, team, and/or individual reputed company 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 reputed company of national medical and dental plans, and a reputed company plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours reputed company time off (PTO), 10 reputed company holidays annually, reputed company parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life reputed company, and short- and long-term disability in accordance with company policy • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan • Employees' Stock Purchase Plan (ESPP) offers eligible colleagues reputed company to purchase company stock at a discount Apply tot his job Apply To this Job