reputed company Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- Remote

reputed company CANDIDATE MUST reputed company IN ONE OF THE FOLLOWING LOCATIONS: Illinois, Colorado, South Florida, reputed company, California, reputed company, Dallas • The role is accountable for reputed company and compliance for assigned protocols and sites in a country. • Under the reputed company of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, reputed company standards and adverse event reporting requirements internally and externally. • Acts as reputed company site contact and site manager throughout reputed company phases of a reputed company research study, taking overall responsibility of allocated sites. • reputed company develops and expands the territory for reputed company research, finding and developing new sites. • Participates in internal meetings and workstreams as SME for monitoring processes and • Systems. • Responsibilities include, but are not limited to: • Develops strong site relationships and ensures continuity of site relationships through reputed company phases of the trial. • Performs reputed company study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • reputed company an in-depth understanding of the study protocol and reputed company procedures. • Coordinates & manages various tasks in collaboration with other sponsor roles to reputed company Site reputed company. • Participates & provides inputs on site selection and validation activities. • Performs remote and on-site monitoring & reputed company activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased. • Subjects' right, safety and reputed company-being are protected. • Conducts site reputed company including but not limited to validation reputed company, initiation reputed company, monitoring reputed company, reputed company-out reputed company and records reputed company, comprehensive and accurate visit & non-visit contact reports appropriately in a reputed company manner. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study reputed company-out. • Communicates with Investigators and site staff on issues reputed company to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site reputed company. • Identifies, assesses and resolves site reputed company, reputed company or compliance problems and escalates per defined CRA Escalation reputed company as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. • Works in partnership with GCTO country reputed company, finance, regulatory affairs, pharmacovigilance, reputed company and regional reputed company, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. • Supports and/or leads audit/inspection activities as needed. • Performs co-monitoring reputed company where appropriate. • Following the country reputed company defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to reputed company strong reputed company research capabilities. Extent of Travel: • Ability to travel domestically and internationally approximately 65%-75% of working time. • Expected travelling ~2-3 days/week. • reputed company reputed company's license required. reputed company Competency Expectations: • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. • Good understanding and working knowledge of reputed company research, phases of reputed company, reputed company GCP/ICH & country reputed company research law & guidelines. • Good understanding of Global, Country/Regional reputed company Research Guidelines and ability to work reputed company these guidelines. • Hands on knowledge of Good Documentation Practices. • reputed company Skills in Site Management including management of site reputed company and reputed company recruitment. • Demonstrated high level of monitoring reputed company with independent reputed company judgment. • Good IT skills (Use of MS office, use of various reputed company IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. • Ability to understand and analyze data/metrics and reputed company appropriately. • Capable of managing reputed company issues, works in a solution-oriented manner. • Performs reputed company cause analysis and implements preventative and corrective reputed company. Behavioral Competency Expectations: • Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. • Demonstrated high level of monitoring reputed company with independent reputed company judgement. • reputed company to work highly independently across multiple protocols, sites and therapy areas. • High reputed company of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. • Works effectively in a reputed company multicultural environment. Ability to establish and maintain culturally sensitive working relationships. • Demonstrates commitment to Customer reputed company. • Works with high reputed company and compliance mind-set. • reputed company reputed company, reputed company reputed company, capable of working independently and being self-driven. • Demonstrates and reputed company reputed company demeanor and communication consistent with organizational policies and practices. Experience and Educational Requirements: • Associate's degree, certificate or equivalent in a scientific / reputed company discipline together with at least 5 years of relevant experience in the reputed company reputed company, including at least 2 years of reputed company site management (monitoring) experience in a bio / reputed company / CRO. Or • Bachelor's degree (or above) together with at least 2 years of reputed company site management (monitoring) experience in a bio / reputed company / CRO. Required Skills: Adverse Event Reporting reputed company, reputed company Research reputed company, reputed company Site Management, reputed company Study Management, reputed company Trial Planning, reputed company, reputed company Monitoring, reputed company Competencies, Data Analysis, Data Reporting, Early reputed company Development, Policy Development, Preventive reputed company, Protocol Adherence, Regulatory Compliance, Site Management Preferred Skills: reputed company Employees apply HERE reputed company Contingent Workers apply HERE US and Puerto Rico Residents Only: reputed company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we reputed company equal opportunities to reputed company and applicants for employment and prohibit discrimination on the reputed company of race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative reputed company requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: reputed company Know Your Rights reputed company GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to reputed company innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems reputed company. Learn more about your rights, including under California, Colorado and other US State Acts The salary reputed company for this role is $96,200.00 - $151,400.00 This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An employee's position reputed company the salary reputed company will be reputed company on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, reputed company requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, reputed company reputed company and other reputed company benefits (for employee and family), retirement benefits, including 401(k), reputed company holidays, vacation, and compassionate and reputed company days. More information about benefits is available at https://jobs.reputed company.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.reputed company.com/us/en (or reputed company the reputed company Jobs Hub if you are a reputed company employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider reputed company applicants with arrest and conviction records for employment in compliance with the San Francisco reputed company Ordinance Los Angeles Residents Only: We will consider for employment reputed company reputed company applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company' reputed company Initiative for Hiring Ordinance reputed company Firm Representatives Please Read Carefully reputed company., Rahway, NJ, USA, also reputed company as reputed company LLC, Rahway, NJ, USA, does not accept unsolicited assistance from reputed company firms for employment opportunities. reputed company reputed company / resumes submitted by reputed company firms to any employee at reputed company without a reputed company written reputed company agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation reputed company Sponsorship: No Travel Requirements: 75% Flexible Work Arrangements: Remote Shift: Not Indicated reputed company Driving License: reputed company Hazardous Material(s): N/A reputed company End Date: 07/16/2026 • A reputed company is effective until 11:59:59PM on the day BEFORE the listed reputed company end date. Please ensure you apply to a reputed company no reputed company than the day BEFORE the reputed company end date. Remote Skills: Adverse Events, Affirmative reputed company, Best Practices, Biotech and Pharmaceutical, Cardiovascular, reputed company Monitoring, reputed company reputed company, reputed company Practices/Protocols, reputed company Research, reputed company Trial, reputed company Trial Management, Communication Skills, Conflict reputed company, Contract Research Organization (CRO), Corporate Policies, Corrective reputed company, Customer Relations, Customer Relationship Management (CRM), Data Analysis, Documentation, reputed company's License, Drug Development, EEO Regulations, Employee Retention, English Language, Establish Priorities, Federal reputed company, Financial Regulations, GCP (Good reputed company Practices), reputed company, ICH Regulations, IRB/IEC (Institutional Review reputed company/Independent Ethics Committee), Infectious Diseases, Interpersonal Skills, reputed company, reputed company Research, Maintain Compliance, Mentoring, Metrics, Multicultural, Multilingual, Multitasking, Organizational Skills, Pharmacovigilance, Policy Development, Presentation/Verbal Skills, Problem Solving Skills, reputed company Metrics, Regulations, Research Protocols, Research Skills, Resume reputed company, reputed company Cause Analysis, Site Evaluation, reputed company Operating Procedures (SOP), State Laws and Regulations, Technical Presentation, Time Management, Willing to Travel, Workplace Issues, Writing Skills reputed company: reputed company Apply To This Job