• Support the statistical design for oncology clinical utility studies. • Serve as study statistician for multiple studies. • Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders. • Recommend and apply novel statistical approaches where appropriate.

Company : Allegheny Health NetworkJob Description : This is a remote/work from home role but preferred candidates will live within 50 miles of the Pittsburgh or Erie region. GENERAL OVERVIEW: Improves the overall quality and completeness of medical documentation; facilitates enhancements to clinical documentation through extensive interaction with physicians, nursing staff, case managers, other patient caregivers, and medical records coding staff to ensure that the appropriate reimbursement is received for the level of service rendered to all inpatients; ensures the accuracy and completeness of clinical information used for measuring and reporting physician and hospital outcomes; educates all members of the patient care team on an ongoing basis. ESSENTIAL RESPONSIBILITIES: - Facilitate appropriate clinical documentation through concurrent, prospective, and retrospective medical record review (30%) - Facilitate modifications to clinical documentation through extensive interaction with physicians, nurses and ancillary staff based on knowledge of coding and HCC guidelines, documentation strategies, and clinical documentation requirements (25%) - Work collaboratively with coding professionals to assure documentation of diagnoses and comorbidities are a complete reflection of the patient's clinical status and care (10%) - Formulate credible clinical documentation clarifications to improve clinical documentation (10%) - Educates all internal customers on compliant documentation responsibilities, coding, and reimbursement issues, as well as performance improvement methodologies (15%) - Performs other duties as assigned or required (10%) QUALIFICATIONS: Minimum - High school/ GED - Bachelor's Degree in Nursing OR Relevant experience and/or education as determined by the company in lieu of bachelor's degree - 5 years in a nursing role - Current State of PA RN licensure OR Current multi-state licensure through the enhanced Nurse Licensure Compact (eNLC) ​ Preferred - Experience in Clinical Documentation Integrity (CDI) - Experience in Coding - Knowledge of ICD 10 and HCC coding guidelines - Knowledge of Electronic Medical Record (Epic) - Knowledge of Encoder (3M 360 Encompass) - Excellent communication skills - Critical thinking skills - Certified Coding Specialist (CCS) - Certified Outpatient Clinical Documentation Improvement Specialist (CCDS-O) - Certified Clinical Documentation Improvement Specialist (CCDS) - Certified Clinical Documentation Improvement Professional (CDIP) Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job. Compliance Requirement: This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies. As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company’s Handbook of Privacy Policies and Practices and Information Security Policy. Furthermore, it is every employee’s responsibility to comply with the company’s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements. Pay Range Minimum: $30.10 Pay Range Maximum: $48.54 Base pay is determined by a variety of factors including a candidate’s qualifications, experience, and expected contributions, as well as internal peer equity, market, and business considerations. The displayed salary range does not reflect any geographic differential Highmark may apply for certain locations based upon comparative markets. Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law. We endeavor to make this site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact the email below. For accommodation requests, please contact HR Services Online at HRServices@highmarkhealth.org California Consumer Privacy Act Employees, Contractors, and Applicants Notice

Job Description This individual will manage all IRB reviews under the auspices of the Northwell Health Research Intelligence Institutional Review Board (IRB) and will oversee all IRB responsibilities related to newly implemented clinical research for Northwell. Additionally, this individual will review nonclinical trial, expedited or exempt research, as needed. The incumbent will specialize in concepts associated with FDA regulations and the research protocol review and submission process to ensure compliance with local, state, and federal regulations and guidance. The IRB analyst will assist researchers, staff, and other stakeholders with drafting and editing protocols and consent forms and interprets regulations when analyzing research submissions to identify research requirements. Conducting in-depth pre-reviews and drafting meeting minutes will be required. This individual provides feedback to investigators and research staff to guide them in making necessary modifications to submissions in order to meet applicable institutional, regulatory, and other requirements for obtaining approval and maintaining compliance with committee guidance. Job Responsibility - Analyzes, verifies, tracks and performs preliminary administrative review of items referred to IRB and communicates deficiencies or questions to investigators; assists in preparation of reports and correspondence related to IRB activities. - Reviews proposed research for compliance with federal, state and local regulations; determines category of review and assess risk; evaluates need for further clinical or professional review of research. - Provides support to investigators by assuring the accuracy of submissions and modifications; responds to investigators regarding deficiencies, inconsistencies or concerns. - Monitors continuing review of research for compliance; identifies and reports items of concern for further action. - Maintains accurate records, including database management; provides assistance in the performance of internal quality improvement activities. - Assists in facilitating and recording IRB meeting minutes and review activities. - Conducts and documents expedited IRB reviews of human subjects’ research. - Supports investigators in developing the IRB submissions for human subject research projects. - Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action. - Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions. Other Key Responbilities: - Communication Management: - Manages personal and shared inbox to ensure prompt response to stakeholder concerns - Escalates matters of concern to the Senior IRB Director or IRB Manager as appropriate - Provides regulatory guidance to IRB members, Chair, and critical stakeholders as needed. - Meeting Preparation and Follow-up: - This individual has the primary responsibility of moving submissions through the office workflow in a timely manner, ensuring that submissions are review-ready prior to routing for committee review, conducting certain non-committee reviews, and generating correspondence after the review process is complete along with coordinating the activities of IRB - Coordinates regular IRB meetings and arranges ad Hoc meetings with the assistance of the IRB project manager, as needed, ensuring appropriate timing and preparation. - Evaluates all submission materials to determine consistency with IRB requirements for approval, including all local policies, applicable federal, state and local law and Good Clinical Practices - Maintains quorum during IRB meetings - Ensures appropriate communication of meeting determinations and timely follow up for all internal and external stakeholders - Works with senior leadership to draft communications, as needed, for internal and external communication of IRB determinations that impact on local, state, or federal law. - Office Management: - Conducts pre-review to ensure that submissions are review ready, routes submissions appropriately for either non-committee or committee review, and communicates review results to investigators and others as needed - Prepares for, coordinates and facilitates IRB Committee meetings, which includes, but is not limited to: Preparing submissions for review by the convened IRB, Assigning reviewers to submissions, Managing IRB meeting agenda volume, Confirming IRB member meeting attendance to ensure quorum, Monitoring quorum during IRB meetings, Documenting determinations made by the convened IRB, Generating IRB meeting minutes and correspondence - Provides feedback to leaders regarding updates/edits needed to the HRPP, IRB functions, and educational needs (deficiencies) of the IRB Committee, research community, and IRB staff - Identifies issues that arise within work processes and escalate to team leadership. - Maintains organization of documents for audit and accreditation - Maintains current working knowledge of the regulations for the safety and protection of human subjects in research and stays current of any changes to the regulatory landscape that may affect the research community - Customer Service: - Delivers high-quality service - Provides regulatory expertise, guidance, and administrative support with empathy, reliability, and professionalism. - Other Administrative Support: - Performs general administrative duties and event organization as needed. Job Qualifications: - Bachelor's Degree required, or equivalent combination of education and related experience. - Minimum 2 years experience in research administration, required. Highly Preferred Skills: - Exceptional organizational skills and attention to detail.  - Excellent communication skills, both oral and verbal.  - Ability to maintain a high level of professionalism and confidentiality.  - Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). - Proficient in procedures associated with IRB record keeping and documentation.  - Ability to adapt to a fast-paced environment and manage changing priorities.  - A proactive problem-solver with strong critical thinking skills.  - Detail-oriented with the ability to multi-task and prioritize workload - Certified IRB Professional (CIP) expected after two years in the job based on certification requirements *Additional Salary Detail The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Description of Role The Sr. Clinical Trial Associate (Contractor) will perform tasks to support the planning and execution of clinical studies across one or more clinical trials. This position will work closely with the Clinical Trial Manager (CTM) to ensure site start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs), GCP and regulatory guidelines. Key Responsibilities - Assists and provides support to the CTM and study team in the day-to-day operational management of assigned clinical trials. - Supports the CTM in coordination, preparation, and documentation of internal and external meetings such as Kick-Off Meetings, Investigator Meetings, and vendor management meetings by preparing agendas, minutes, and presentation materials, organizing meeting logistics and travel arrangements if necessary. - Take responsibility for meeting logistics, agendas, and minutes of the clinical study team in accordance with standards. - Assist with tracking of purchase orders and invoices, site budgets, investigator payments, CTAs, etc. - Assists in tracking key site metrics and milestones such as Site Initiation Visits and site activation, subject recruitment and enrollment, critical study dosing days and assessments, scheduled Monitoring Visits and Close-Out Visits etc. - Contribute to study level tracking by maintaining tools to track assignment and training of study team members, recruitment materials and compliance tools, laboratory kits, samples and study supplies, vendor portal access, etc. - Support the CTM in the oversight of study vendors; including review of invoices. - Supports the CTM and contributes to the review of clinical documentation such as Informed Consent (ICF), Study Reference Binder, Study Management Plans, Monitoring plan, study protocols etc. - Manages and maintains the study team SharePoint - Assists in clinical site oversite, data entry timeliness, review of monitoring trip reports and tracks resolution of all action items. - Assists in TMF management to ensure it is being maintained up-to-date and all essential documents are appropriately filed in the TMF. - Assist CTM and study team in the review and cleaning of study data in preparation for database lock. Qualifications - B.A. or B.S. degree required. - 4+ years' experience within a biotech or pharmaceutical organization with at least 2 years in clinical operations. - Experience working with clinical sites, principal investigators, clinical operations staff and CROs a plus. - Knowledge and training on Good Clinical Practice (GCP) for clinical research studies. - Computer skills should include proficiency with Microsoft Office software, specifically, Outlook, Word, and Excel. - Independently motivated, detail oriented and good problem-solving ability. - Excellent written and verbal communication skills. - Flexible and able to adapt to new situations as the business demands. - Ability to work effectively from a virtual home office setting. - Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones. - Occasional travel may be required to attend investigator meetings, site visits, and/or professional conferences. Amount of travel required is study-specific. Compensation The hourly rate for this position is $65.00 to $75.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. This position is a contract role and is not eligible for company employee benefits, including but not limited to health insurance, retirement plans, paid time off, or other employee programs. Individuals engaged in this role will be employed by and receive compensation through Centessa's designated employer of record. Work Location The Sr. Clinical Trial Contractor is a remote role based in the US POSITION: Temporary, Non-Exempt EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.