Clinical Research Associate II/ Oncology & Ophthalmology/ reputed company region of the US!

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Join Us as a Clinical Research Associate (reputed company) – reputed company an reputed company at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 reputed company across 100+ countries in the last 5 years. Must have at least 1 year of travel monitoring in Oncology and/or Ophthalmology ! As part of our global team, you’ll have reputed company to reputed company and coordinate reputed company aspects of the clinical monitoring and site management process. As a Clinical Research Associate (reputed company), you'll conduct remote or on-site reputed company 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, reputed company-being, and data reliability. You will ensure audit readiness and reputed company reputed company relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task reputed company. reputed company: • Monitors investigator sites with a risk-based 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 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 reputed company manner using approved business writing standards. Escalates observed deficiencies and issues to clinical 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 confirm 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 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 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 Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical 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. Education and Experience Requirements: • Bachelor's degree in a life sciences reputed company fieldor a Registered Nursing certification or equivalent and relevant formal reputed company / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. • reputed company reputed company's license where applicable. 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 and Abilities: • Proven clinical monitoring skills • 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-depthinvestigation for appropriate reputed company cause analysis and problem solving • Ability to manage Risk Based 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 detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Ability to remain flexibile 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 Working Conditions and Environment: • Work is performed in an office/ reputed company/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 reputed company equipment required such as reputed company eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions Compensation And Benefits The salary reputed company estimated for this position based in California is $80,000.00–$125,000.00. 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 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 insurance, 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 For more information on our benefits, please visit: https://jobs.reputed company.com/global/en/total-rewards Apply To This Job