• Perform Medicare coverage analysis and participation in ancillary service reviews along with assistance in research study activations within HealthLink (EPIC) • Review all charges related to clinical trials to ensure Medicare coverage rules and clinical trial contracts are adhered to • Serve as the primary point of contact and technical expert for complex research billing workflows, including providing ongoing updates, training, and involvement in research-related IT projects • Collaborate and build strong working relationship with clinical research departments and clinical research compliance

Role Description The Sr. CRA II will perform the following responsibilities: - Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely) ensuring compliance with regulatory, ICH-GCP, GPP, and protocol standards. - Evaluate overall site performance and provide recommendations for site-specific actions, communicating serious issues to the project team. - Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs. - Verify informed consent processes for each subject/patient. - Protect confidentiality of subjects/patients and assess factors affecting safety and data integrity. - Conduct Source Document Review and verify clinical data accuracy and completeness. - Apply query resolution techniques and guide site staff as necessary. - Utilize hardware and software for effective clinical study data review and capture. - Perform investigational product (IP) inventory and ensure compliance with protocols. - Review the Investigator Site File (ISF) for accuracy and completeness. - Document activities as per SOPs and Clinical Monitoring Plan/Site Management Plan. - Support subject/patient recruitment, retention, and awareness strategies. - Understand project scope, budgets, and timelines, managing site-level activities to meet objectives. - Act as primary liaison with study site personnel, ensuring compliance with requirements. - Prepare for and attend Investigator Meetings and sponsor meetings. - Provide guidance towards audit readiness standards and support audit preparations. - May supervise, train, and mentor junior CRAs. - For Real World Late Phase (RWLP), responsibilities include: - Site support throughout the study lifecycle. - Chart abstraction activities and data collection. - Collaborate with Sponsor and local staff. - Train junior staff as requested. - Identify and communicate out of scope activities. - Propose potential sites based on local knowledge. - Identify operational efficiencies and process improvements. - Develop informed consent forms. - Collaborate with RWLP Regulatory team. - Participate in bid defense meetings and provide input into RFPs. - Participate in Case Report Form design and edit check development. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience. - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - Demonstrated good computer skills and ability to embrace new technologies. - Excellent communication, presentation, and interpersonal skills. - Moderate level of critical thinking skills expected. - Ability to manage required travel of up to 75% on a regular basis. Benefits - Career development and progression opportunities. - Supportive and engaged line management. - Technical and therapeutic area training. - Peer recognition and total rewards program. - Inclusive culture where you can authentically be yourself.

Role Description The Clinical Research Associate (CRA) is a primary point of contact at the site level for both internal and external stakeholders, responsible for overseeing the quality, integrity and compliance of clinical trial sites in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and applicable regulatory requirements. - Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP. - Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites. - Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. - Provide training and support to site staff to uphold these standards and ensure patient safety. - Participate in sponsor and/or Health Authority audits and inspections as applicable. - Cultivate and sustain effective relationships with internal cross functional teams and external partners, including vendors, clinical sites, and key stakeholders. - Motivate and influence sites to meet study objectives, including enrollment and retention goals. - Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method. - Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner. - Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. - Identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process. - Demonstrate understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches. - Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues. - Utilize strong analytical skills to evaluate site data and operational metrics. - Perform Unblinded Site Monitoring activities to protect the blind of the study. - Accountable for the review, reconciliation, and oversight of study drug/IMP. - Involvement in Regulatory Compliance audit/inspection process, as needed. - Support start-up and submission related activities, including ICF reviews and collection of documents to/from site. - Support provision of access to relevant BMS and vendor systems for clinical trial site personnel. - Support coordination of site activities related to database locks to ensure timelines are met. - Perform timely site closure activities when all required protocol visits and follow-up are completed. - Functions independently and acts autonomously. - Participates in site level root cause analysis and CAPA (Corrective and Preventive Actions) processes. Qualifications - Bachelor’s degree required, preferably within life sciences or equivalent. - Valid driver’s license (as locally required). Requirements - 2-3 years of relevant clinical research experience as a Clinical Research Associate. - Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred. - Experience in the drug discovery/development process. - Knowledge and understanding of clinical research processes, regulations and methodology. - Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations. - Strong analytical and critical thinking skills. - Good verbal and written communication skills (both in English and local language). - Ability to manage multiple protocols across multiple therapeutic areas. - Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards). Benefits - Wide variety of competitive benefits, services and programs. - Resources to pursue goals, both at work and in personal lives.

• Draw thoughtful conclusions from complex, mostly qualitative data from a cacophony of often-conflicting sources. • Identify and collect the data you need to do so through a range of channels, including interviewing and surveying GRB members, analyzing proprietary data, conducting secondary desk research, and speaking to key players throughout the broader technology ecosystem. • Propose and test insightful ideas through primary and secondary research and convey them in polished written, graphical, and verbal products. • Aid in developing content and facilitating conversations that support our members’ most important initiatives. • Identify and connect with industry leaders, academics, and startup executives, both to conduct research interviews and to build our extensive set of ecosystem and thought-leader relationships. • Master research processes with an eye towards continuous innovation to ensure the GRB continues to provide world-class service. • Utilize approved AI tools to improve efficiencies in our business and deliver even greater value for our clients. • Able to solve complex problems and successfully manage ambiguity and unexpected change. • Teachable and embracing of best practices and feedback as a means of continuous improvement.