Conduct site qualification, initiation, monitoring, and close-out visits while ensuring compliance with regulations. Verify informed consent, assess site processes, and manage site-level activities to meet project objectives and timelines.

Join Our Team as a TVT Clinical Data Abstractor at Carta Healthcare! Company: Carta Healthcare Inc. Position: Full Time TVT Clinical Data Abstractor Location: 100% Remote Are you experienced in clinical data abstraction? Carta Healthcare Inc. is seeking talented individuals to join our growing team as Full-Time TVT Clinical Data Abstractors! Join our team at Carta Healthcare, where we offer opportunities for experienced clinical data abstractors. We offer a flexible work schedule that allows for a balanced work-life experience. About Us: At Carta Healthcare, we are revolutionizing the way healthcare data is managed and used with innovative software solutions. Position Overview: As a Full-Time Clinical Data Abstractor, you will be responsible for abstracting and coding patient information from medical records to meet the requirements of various target registries. What We’re Looking For: - Minimum of 1 year of recent clinical data abstraction experience - Proficiency with EMR systems - Maintain a 98% or higher IRR score - Previous remote work experience preferred - Available for a minimum of 60 abstraction hours monthly Why Join Us? - Schedule: 40 hours per week, Monday–Friday - Location: 100% remote - Equipment: Laptop provided - Paid Holidays: 12 days per year - PTO: PTO: Carta Healthcare offers a flexible paid time off plan. Additional details will be shared during the hiring process. - Health Benefits: Medical, dental, and vision insurance. Includes extended PTO, bonus eligibility, and enhanced health plan tiers. - Overtime: No overtime eligibility (exempt classification) - Sick Leave: Per state/company policy In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. All applicants are required to reside within the continental United States. Carta Healthcare is dedicated to building a diverse and inclusive company because we serve health systems across the country; we’ve seen how our product and impact are strengthened the more we reflect that diversity. In addition, we have found and strongly believe that diverse teams are higher-performing, and we embrace the varied perspectives that our team members share with each other. As such, we are an Equal Opportunity Employer. #LI-Remote #BI-Remote

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Various outside weather conditions Job Description Join Us as a Senior Clinical Research Associate (Level I) – 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 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 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. 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 Working Conditions and Environment: • Working Conditions and Environment: • Work is performed in an office/ laboratory/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 protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions. • Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site.

• Monitors the progress of clinical studies at investigational sites or at company headquarters and ensures they are conducted, documented and reported in accordance with the study protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and all applicable regulatory requirements. • Establishes and maintains collaborative relationships with investigators, Contract Research Organizations (CROs), affiliated hospitals and research institutions to initiate and advance clinical studies for investigational products or medical devices. • Responsible for the review of adverse events together with investigators, for planning and monitoring timelines, budgets and milestones, for preparing study-related documentation and for producing status reports. • May support the design, development and oversight of clinical evaluation projects where applicable. • Trains investigators and site staff. • Includes duties of Clinical Research Associates (CRA) performed both from a home office and in the field. • Implements and helps prepare the clinical development strategy defined by the clinical teams. • May contact qualified investigators and recommend them for study conduct and trial initiation. • Ensures recruitment and retention of study participants.