The World Leader In Serving Science
Senior Clinical Research Associate - Oncology
Location
California + 1 moreAll locations: California | Nevada
Posted
38 days ago
Salary
$82.8K - $154.6K / year
Seniority
Senior
Job Description
Senior Clinical Research Associate - Oncology
Thermo Fisher Scientific
Title: Sr CRA - FSP Oncology - California & Central Location: - Remote, Nevada, United States of America - West Sacramento, California, United States of America First Shift (Days) Full time Remote As 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 Senior Clinical Research Associate (Level 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 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. What You’ll Do: • Monitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV andCRF 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 • Provides 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, CTMS). Performs QC check of reports generated from CTMS system where required. • Participates 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. Ensures trial close out and retrieval of trial materials. • Ensures 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. • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc). • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. • 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. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor). • Valid driver's license where applicable • In 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. Knowledge, Skills and Abilities: • Effective clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving • Ability to manages Risk Based Monitoring concepts and processes • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detailand the ability to perceive customers’ underlying issues • Effective interpersonal skills • Strong attention to detail • Effective organizational and time management skills • Ability to remain flexible and adaptable in a wide range of scenarios • Ability to work in a team or independently as required • Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills Compensation and Benefits The salary range estimated for this position based in Nevada is $82,800.00–$154,613.00. 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 programs - Employee assistance and family support programs, including commuter benefits and tuition reimbursement - At 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 policy - Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan - Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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• Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements; • Identifies quality issues and trends related to site performance and clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, quality control visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions; • Serves as a point of contact for CRAs and Lead CRAs for assigned projects; • Provides mentoring/oversight of CRAs and Lead CRAs; • Performs site visit report review for assigned projects and tracks site visit report metrics to ensure compliance; • Contributes to the development of the Clinical Monitoring Plan; • Prepares and conducts project-specific training for the CRAs; • Develops the annotated site visit reports and monitoring tools such as source data verification worksheets; • Conducts quality control visits with CRAs; • Coordinates and leads CRA meetings; • Performs co-monitoring visits with CRAs; • May be involved in business development activities (client meetings, proposal defense meetings, requests for proposals (RFPs) requests for information (RFIs)).
Neuroscience Clinical Research Project Specialist
American College of RadiologyA certified Great Place to Work®, the American College of Radiology is the voice of #radiology.
• Partner with research site staff to streamline and support activation, accrual, ongoing operations, and close-out activities for assigned clinical research studies. • Draft and refine essential clinical study documents, including project plans, protocols, informed consent forms (ICFs), and site-facing operational resources. • Generate and manage concept documents for IRBs, imaging oversight committees, grant applications, and business proposals. • Lead protocol team operations by managing regular calls, distributing action-oriented minutes, coordinating protocol amendments, and facilitating site educational sessions. • Manage and track all assigned project deliverables, providing regular metrics and progress reports to leadership and external stakeholders. • Guarantee that all study activities and documentation strictly adhere to Good Clinical Practice (GCP) guidelines and the Code of Federal Regulations (CFR).
