• Assists in developing plans for research projects and discusses the interpretation of results • Collaborates in the preparation of manuscripts for publications and preparing grant proposals • Assists in preparation of amendments to protocols and/or modifications to study design • Coordinates the development of forms, questionnaires and application of research techniques • Implements and manages all phases of study/protocol ensuring compliance with guidelines • Analyzes, investigates and reports adverse events; makes decisions on participant inclusion and protocol adjustments

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate (Level II) – 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 Clinical Research Associate (Level II), 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. • 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. 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 Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). • 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 the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. • 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 1 years min for CRA 2 and 3 years min for SR CRA as a clinical research monitor) or completion of PPD Drug Development Fellowship. • 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: • Proven clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Good 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 detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Ability to remain flexibile and adaptable in a wide range of scenarios • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills 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

Position Summary: The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member. Essential functions of the job include but are not limited to: - Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Updates, tracks and maintains study specific trial management tools/systems, and status reports. - If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager. - If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. - Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. - Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. - Performs investigational product (IP) inventory, reconciliation and reviews storage and security. - Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. - Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. - Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process. - Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team. - Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Travels as necessary according to project needs. - Performs other duties as assigned by management. Qualifications: Minimum Required: - Europe: University degree life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or be a licensed health care professional. - America: 4-year college degree or equivalent experience in a scientific or healthcare discipline. - Two (2) years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research Other Required: - Excellent communication and organizational skills are essential. A team player. - Experience monitoring oncology trials - Evidence of a client focused approach - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail. - Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed. - Fluency in English and for non-English speaking countries the local language of country where position based Preferred: - Graduate or postgraduate degree - Auto-immune monitoring experience - Experience monitoring in rare and complex therapeutic areas - Experience monitoring EDC trials and EHR records - Experience in biopharma or relevant therapeutic area - Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country - Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines. - Ability to resolve project related problems and prioritizes workload to meet deadlines with minimal support from management. Competencies: - Exhibits self-motivation and is able to work and plan independently as well as in a team environment - Understands clinical trials methodology, including a working knowledge of protocols and indications being studied - Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills - Collects data of consistently high standard - Demonstrated ability to conduct formal presentations to a wide variety of audiences including, colleagues, investigative staff, and clients with a high level of proficiency - Fluency in English and for non-English speaking countries the local language of country where position based Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $91,500—$137,300 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Overview To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day. The Nurse Applications Specialist II functions as the primary support contact and expert for the clinical application. They work under the direction of the Applications Manager to configure, build & install the application. They coordinate all issues that arise during the project for their application area. Primary responsibilities include analyzing work flows and understanding policies, procedures and constraints of the clinical or business operations. In depth and precise investigation and documentation of operational specifications and application functionality is required. A key technical activity is to analyze new releases to determine how workflow should be modified. They function as the primary contact to troubleshoot problems and questions from end-users during training, go-live and stabilization periods. Attention to detail is a critical skill for this position. Successful candidates enjoy helping other users learn and adopt usage of the application. They collaboratively with all Departments within the Information Systems Division, Clinical Departments and other Departments as necessary in problem solving issues related to the application, communication, documentation, and in the implementation and maintenance of the application. EEO/AA/Disability/Veteran Responsibilities - 1. Application Development - 1.1. Supports new application development including system analysis, planning and preparation. 1.2. Demonstrates extraordinary ability to perform the technical skills of the job. 1.3. Works with Nurse Applications Specialists I, to enhance technical and analytical skills, provide support and provides recommendations and participates in design and code walkthroughs. 1.4. Designs, programs and tests conversions, interfaces, reports and other computer programs according to the departmental standards. 1.5. Analyzes the need for development of in-house programs to support the new system, including programs needed to convert data from the old to the new system. 1.6. Identifies and recommends changes in workflow, procedures, forms and/or data to make optimal use of the new system. 1.7. Provides Epic product function, design, and build expertise and experience needed for successful implementation. 1.8. Assists in resolving major design issues and presents options for resolution. 1.9. Analyzes business processes to ensure proper system configuration. 1.10. Logs, tracks, and resolves issues and changes in regards to software code modifications or enhancements. 1.11. Meets with users to determine specifications of particular hardware or software needs. 1.12. Informs management of all issues that are impacting or will impact assigned area/s. - 2. Teamwork - 2.1. Creates and maintains regular status reports to immediate Applications Coordinator. 2.2. Attends weekly team meetings to discuss team and project related activities, issues, change, communications, and updates. 2.3. Completes specific task activities as documented on the Work Plan. 2.4. Works with training team to develop application specific training curriculums and materials. 2.5. Supports all project team members with application and information systems knowledge. 2.6. Promotes a team atmosphere that is conducive to the overall accomplishment of goals, schedules, and deadlines. 2.7. Openly shares information with all team members. 2.8. Willingness to subordinate individual goals for team goals. - 3. Documentation - 3.1. Documents and maintains all required system design and build documents and configures system accordingly. 3.2. Contributes to preparation of testing scripts and materials and performs unit, system, and integrated testing tasks. 3.3. Provides expertise and experience to the development of production environment readiness plan. - 4. Other - 4.1. Provides training to other IT staff and user clients as appropriate. 4.2. Coordinates interactions and activities of vendors, both on-site and off-site. 4.3. Work closely with end users to identify business needs and benefits of implementing a computing solution and strives to understand their needs Qualifications EDUCATION Valid CT Registered Nurse license strongly preferred. EXPERIENCE 3 years clinical experience required. Minimum of one year of experience in a clinically related IT role required. Successful completion of the career ladder process and documentation. LICENSURE Required to attend out of state training. Certification in the Epic application is required. SPECIAL SKILLS Ability to work independently and meet deadlines with minimal supervision and ability to deal with simultaneous tasks, communicate effectively, problem solve, and develop creative solutions to complex problems required. Strong organizational. problem solving and listening skills, attention to detail, innovative thinking and ability to inspire others required. Must possess a high level of customer service skills and participate as strong, collaborative team player. Working knowledge or experience in Microsoft Office tools and an understanding of computer system capabilities to address process requirements required. YNHHS Requisition ID 177366