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ICON plc logo
ICON plc

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients, and suppliers.

Senior CRA

Clinical ResearchClinical ResearchOtherRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

100 days ago

Salary

0

Seniority

Senior

No structured requirement data.

Job Description

Senior CRA

ICON plc

Sr CRA - Oncology Southeast ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What You Will Be Doing: - Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. - Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution. - Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting. - Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct. - Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations. Your Profile: - Advanced degree in a relevant field such as life sciences, nursing, or medicine. - Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. - Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills. - Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools. - Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment. - Five years of CRA experience with oncology monitoring experience - Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license - Must be located in the US Southeast - Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

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OtherRemoteTeam 10,001+Since 1888H1B Sponsor

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United States
$61.3K - $122K / year
OtherRemoteTeam 10,001+Since 1888H1B Sponsor

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United States
$86.7K - $173K / year
OtherRemoteTeam 10,001+Since 1956H1B Sponsor

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coord, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed. What You’ll Do: • According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix. • Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s). • Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads. • Provides system support (i.e., Activate & eTMF) and ensures system databases are always current. • Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members. • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. • Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. • Assists with study-specific translation materials and translation QC upon request. • Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided. • Where applicable, conducts on-site feasibility visits (Asia Pac only). • May support scheduling of client and/or internal meetings. • May review and track of local regulatory documents. • May provide system support (i.e., Activate & eTMF). May support RBM activities. • May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s). • Transmits documents to client and centralized IRB/IEC. • Maintains vendor trackers. • Supports start-up team in Regulatory submissions. • Works directly with sites to obtain documents related to site selection. • Assists the project team with the preparation of regulatory compliance review packages. • Provides support as needed to coordinate with internal departments, ensuring site start-up activities within the site activation critical path are aligned. • May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. • Documents in real time all communication, attempts an follow up associated with site contact and survey responses. • Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked. • Works in collaboration with teammates to achieve targeted deadlines for assigned projects. 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Education and Experience Requirements: • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. • Bachelor's degree preferred. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). 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: • Ability to work in a team or independently as required • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Flexibility to reprioritize workload to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout • Good English language and grammar skills and proficient local language skills as needed • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems • Ability to successfully complete the organizations clinical training program • Self-motivated, positive attitude and good interpersonal skills • Effective oral and written communication skills • Good interpersonal skills • Essential judgment and decision-making skills • Capable of accurately following project work instructions • Good negotiation skills • Independent thinker • Ability to manage risk and perform risk escalation appropriately Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment. • Occasional drives to site locations. Potential Occasional travel required.

United States
Job Closed
IU Health logo

Clinical Documentation Specialist

IU Health

Indiana University Health is the largest health system in Indiana with nearly 40,000 team members, 15 hospitals and $8.64 billion in operating revenue. The system’s programs in cancer, cardiovascular, neuroscience, orthopedics, pediatrics and transplants have received national recognition for quality patient care. IU Health, in partnership with the Indiana University School of Medicine, brings together highly skilled physicians, researchers, and educators into close collaboration to provide world-class care for children and adults and improve the health of patients and communities across Indiana. Indiana University Health is dedicated to a fair hiring process and is committed to equal opportunity and nondiscrimination for all individuals, regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, gender identity, expression, sexual orientation, or veteran status. IU Health is invested in the lives of Hoosiers, leading the transformation of healthcare to make Indiana one of the nation’s healthiest states. As an employee of Indiana’s most comprehensive health system, we are excited to support team members who are inspired by challenging and meaningful work for the good of every patient.

Clinical Research100 days ago
OtherRemoteTeam 10,001

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Clinical Documentation Specialist enhances the overall quality and accuracy of clinical documentation on a concurrent and retrospective basis through daily review and interactions with physicians and healthcare providers. They utilize clinical and coding expertise to analyze documentation, ensuring it accurately reflects the level of service provided. This role supports timely and precise capture of quality metrics to improve patient care, physician documentation, and hospital outcomes. - Perform daily review of clinical documentation and interact with physicians and providers to ensure completeness and accuracy. - Analyze and evaluate documentation to ensure it reflects appropriate levels of care and supports quality measures. - Support timely coding and documentation processes to optimize hospital and physician performance metrics. - Collaborate with clinical teams to identify documentation gaps and implement improvement strategies. - Stay current with coding guidelines, documentation standards, and quality measurement requirements. - Maintain compliance with regulatory and accreditation standards related to clinical documentation. - Support education and training initiatives for staff regarding documentation best practices. - Utilize clinical and coding expertise to support continuous quality improvement initiatives. Qualifications - Associate’s Degree required; Bachelor's Degree preferred. - 0-3 years of relevant experience in clinical documentation, coding, or related fields. - Active Registered Nurse (RN) license in Indiana or Nurse Licensure Compact (NLC) RN license, or RHIA/RHIT and/or CCS certification. - If RN licensed, 3-5 years of strong, varied clinical experience in an acute care setting preferred. - CCDS and/or CDIP credential preferred; obtain within 4 years of hire. - Ability to work independently and produce high-quality outcomes. - Working knowledge of computers and software applications such as Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, SharePoint, Teams) and Cerner EMR. - Ability to sit for extended periods. - Position is remote but may require occasional on-site meetings with advanced notice. Benefits - Comprehensive benefits package including health, dental, and vision insurance - Retirement savings plan with employer match - Tuition reimbursement and professional development opportunities - Employee assistance programs and wellness initiatives - Supportive work environment committed to safety and excellence

United States
Job Closed