As a leading full-service global CRO, we work to create solutions that advance new treatments from discovery to reality.
Senior Clinical Research Associate
Location
United States
Posted
4 days ago
Salary
$97K - $193K / year
Seniority
Senior
No structured requirement data.
Job Description
Senior Clinical Research Associate
Worldwide Clinical Trials
Role Description As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. Collaboration with top-tier colleagues from various backgrounds and specialties is not just encouraged; it's ingrained in our culture. - Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects. - Involved in all stages of the clinical study, including: - Identifying potential sites to participate in the research effort. - Performing various study start-up activities such as working with sites to collect appropriate regulatory documents. - Supporting the negotiation of contracts and budgets. - Training the sites to collect data properly and report any potential safety-related events. - Managing the site's activities during study maintenance. - Closing down research activities at the sites once the study has concluded. - Conduct study initiation visits (SIVs). - Ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements. Qualifications - Excellent interpersonal, oral, and written communication skills in English. - Superior organizational skills with attention to detail. - Ability to work with little or no supervision. - Proficiency in Microsoft Office, CTMS, and EDC Systems. Requirements - 5+ years of experience as a Clinical Research Associate. - 4-year university degree OR Nursing Degree. - Experience in CNS/Neurology is required; Psychiatry is strongly preferred. - Candidates must reside on the West Coast. - Willingness to travel regionally required. Benefits - Competitive salary range: $97,000.00 - $193,000.00 annually. - Competitive benefits package depending on location. - Pay equity and transparency.
Related Guides
Related Categories
Related Job Pages
More Research Analyst Jobs
• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial. • Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe. • Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection. • Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages. • Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments. • Prepare, plan, organize, and conduct site initiation visits. • Develop and maintain appropriate monitoring tools and project-specific documents. • Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines. • Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing. • Reconcile contents of in-house TMF and site’s Investigator Site Files. • Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements. • Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial. • Support strategies to boost recruitment efforts.
Clinical Research Associate, Various Levels
Thermo Fisher ScientificThe World Leader In Serving Science
• Perform and coordinate different aspects of the clinical monitoring and site management process. • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. • Manage procedures and guidelines from different sponsors and/or monitoring environments. • Ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs. • Ensure audit readiness and develop collaborative relationships with investigational sites. • 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. • Maintain regular contact between monitoring visits with investigative sites. Conducts monitoring tasks in accordance with the approved monitoring plan. • Participates in the investigator payment process. • Investigates and follows-up on findings as applicable. • 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 in place, according 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. • Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. • 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.
• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices. • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock. • Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites. • Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed.
Title: Registered Nurse Location: United States Job Description: Become a part of our caring community Are you a transitioning military service member or a military spouse looking for an internship that supports the goal to put health first? The DOW SkillBridge Internship and Military Spouse Fellowship Programs will provide you with key training to perform your internship. You will partner with your team to support members, projects, and to meet goals impacting business outcomes. The professionals you work with at Humana will depend on the type of internship you select. They may include healthcare professionals, HR, and IT, to name a few. The objective is to support and facilitate care for members. To be eligible for this internship, you must either be a transitioning military service member or a military spouse, and you must obtain eligibility to participate in these DOW sponsored programs. The Utilization Management Behavioral Health Registered Nurse (RN) Intern will report to a manager of the National Medicaid team. You will utilize training and engage formerly acquired skillsets to complete medical necessity reviews for behavioral health requested services using clinical judgment and provides referrals to internal stakeholders for further review depending on case findings. You will participate in the following assignments in this role: Clinical Review: - Conduct comprehensive clinical reviews of prior authorization requests to determine medical necessity and benefit eligibility. - Apply advanced evidence-based clinical guidelines in review decisions. - Ensure compliance with accreditation, state, and federal regulations. Communication and Coordination: - Communicate with healthcare providers to obtain necessary clinical information and clarify requests. - Coordinate with medical directors and interdisciplinary teams to support decision-making. - Serve as a liaison between clinicians, internal departments, and members. Documentation and Reporting: - Document all review findings and decisions in clinical documentation systems. - Ensure timely and accurate documentation of prior authorization determinations. - Support reporting initiatives and provide data for performance improvement projects. Quality Assurance: - Implement quality assurance measures to ensure accuracy and consistency in prior authorization decisions. - Conduct regular audits and reviews to maintain high standards of service. - Identify process improvement opportunities and contribute to performance improvement projects. Education and Training: - Educate providers and staff on prior authorization policies, criteria, and review processes. - Provide mentorship and feedback to nonclinical staff and peers to enhance workflow efficiency. - Stay current with clinical best practices and regulatory changes. Use your skills to make an impact Required Qualifications: - You must be a transitioning service member eligible to participate in the DOW SkillBridge or a military spouse eligible to participate in the military spouse fellowship· - Active Registered Nurse, RN, in the state of Kentucky or an enhanced Compact, (eNLC) license without restrictions or disciplinary action.· - Minimum two, (2) years of clinical behavioral health experience. - Working knowledge of MS Office including Word, Excel, PowerPoint, and Teams in a Windows based environment and an ability to quickly learn new systems and ability to troubleshoot and resolve basic technical difficulties in a remote environment. - Proficiency in healthcare software and electronic medical records (EMR) systems. - Possess an interest in working in the managed care industry. Preferred Qualifications: - Bachelor's degree - Previous Medicare/Medicaid experience. - Previous experience in prior authorization, utilization management. - Experience working with MCG or Interqual guidelines. - Certification in Case Management, (CCM) or Utilization Review, (UR). - Knowledge of payer policies, insurance companies and government health programs. Workstyle: Remote Work at Home Location: Must reside in a state that participates in the enhanced compact license, (eNLC) Work Schedule: Weekdays 8:00 AM to 4:30 PM Central Time Travel: None Additional Information Work At Home Requirements - WAH requirements: Must have the ability to provide a high-speed DSL or cable modem for a home office. Associates or contractors who live and work from home in the state of California will be provided payment for their internet expense. - A minimum standard speed for optimal performance of 25x10 (25mpbs download x 10mpbs upload) is required. - Satellite and Wireless Internet service is NOT allowed for this role. - A dedicated space lacking ongoing interruptions to protect member PHI / HIPAA information The DOW SkillBridge Internship Program provides transitioning military service members time to gain civilian work experience while still on active duty with an employer for a period approved by their command and the DOW, with an average timeline of 90 days. The Military Spouse Fellowship Program connects military spouses with employers offering a variety of professional onsite, field, or remote based opportunities for a period up to 12 weeks. - Networking opportunities will be provided while participating in the Internship or Fellowship. - Due to factors such as location, and/or requirements that cannot be modified, full-time employment is not guaranteed upon completion of the Internship or Fellowship. Interview Format As part of our hiring process, we will be using a screening and interviewing technology provided by HireVue, a third-party vendor. This technology provides our team of recruiters and hiring leaders with an enhanced method for decision-making. If you are selected to move forward from your application prescreen, you will receive an email correspondence inviting you to participate in a pre-recorded Voice Interview and/or an SMS Text Messaging interview. (please be sure to check your spam or junk folders often to ensure communication isn't missed) SSN Alert Humana values personal identity protection. Please be aware that applicants may be asked to provide their Social Security Number, if it is not already on file. When required, an email will be sent from Humana@myworkday.com with instructions on how to add the information into your official application on Humana's secure website. Travel: While this is a remote position, occasional travel to Humana''s offices for training or meetings may be required. Scheduled Weekly Hours 1 About us About Humana: Humana Inc. (NYSE: HUM) is a leading U.S. healthcare company. Through our Humana insurance services and our CenterWell healthcare services, we make it easier for the millions of people we serve to achieve their best health - delivering the care and service they need, when they need it. These efforts are leading to a better quality of life for people with Medicare and Medicaid, families, individuals, military service personnel, and communities at large. Learn more about what we offer at Humana.com and at CenterWell.com. Equal Opportunity Employer It is the policy of Humana not to discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status. It is also the policy of Humana to take affirmative action, in compliance with Section 503 of the Rehabilitation Act and VEVRAA, to employ and to advance in employment individuals with disability or protected veteran status, and to base all employment decisions only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment.




