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.

Title: Senior Clinical Research Associate Location: Boston, MA, United States Remote Full-time Salary Min: 94000 Salary Max: 178500 Workday Global Grade: 17 Compensation: USD 94,000 - USD 178,500 - yearly Job Description: Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience. Responsibilities: Considered as the Primary Sponsor Point of contact for the investigative site. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning. Ability to motivate and align monitoring community through leadership and mentorship. - Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able to support, guide, and mentor junior personnel on Site Management activities. - Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. - Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy. - Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape/patient journey to enable successful patient recruitment and overall protocol compliance. - Possesses advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes. - May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager. - Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer-centric approach. - Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators. - Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable. - This is a remote position. Candidates must be based in MA and be willing to travel for site visits. Qualifications - Education: Bachelor's degree or equivalent degree; health-related preferred (e.g. Medical, Scientific, Nursing, Pharmacy). - Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring. - Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials - Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. - Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders. - Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. - Superior ability to leverage technology, tools and resources to provide customer-centric support based on the health of the site. - Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training. - Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues - Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: - The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. - We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. - This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, https://www.abbvie.com/join-us/reasonable-accommodations.html

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Starting pay rate $130k The Mass General Brigham Cancer Institute’s Department of Radiation Oncology is a leader in developing and implementing some of the most innovative and effective radiation therapies in the world. Massachusetts General Hospital and Brigham and Women’s Hospital, founding members of Mass General Brigham, are ranked by U.S. News & World Report as two of the nation’s best hospitals and work together as one team to deliver extraordinary care. Become a member of our department as a Medical Dosimetrist supporting Pediatric Cancer research as part of a collaboration with M3 Pediatric Cancer Registry! M3 (Multi-institutional, Multi-disciplinary, and Multi-omic) Pediatric Cancer Registry: the M3 Collaboration is a comprehensive multi-institutional pediatric cancer and tumor registry that will use AI-augmented and automated procedures to capture multidimensional patient data in pediatric cancer patients to accelerate research and improve disease control and quality of survivorship. Data collection will include treatment exposures (inclusive of radiation treatment plans, surgery, chemotherapies), biologic characteristics of the tumor and patient, and outcomes measures with the purpose of improving cures and quality of survival. This is a merging of efforts from the Pediatric Proton/photon Consortium Registry (PPCR, 26 centers, Massachusetts General Hospital (MGH) lead), the Childhood Brain Tumor Network (CBTN, 37 centers with Children’s Hospital of Pennsylvania lead) and Johns Hopkins Radiation and Advanced Analytics Program. This is funded by a philanthropic grant from an anonymous donor. We look forward to welcoming a new teammate to help support and oversee storage and quality control of pediatric radiation treatment plans for the M3 Collaboration. Most work will be accomplished remotely except for being on site at MGH for onboarding and to institutional sites as needed to assist in development of export methodologies and workflows for image and radiation plan transfers. Competitive Compensation and Benefits Packages including: • Starting pay of $130k annually • Comprehensive Medical, Dental and Vision insurance • Tuition Reimbursement • Paid Parental Leave • Resources for childcare and emergency backup care • Hospital-paid retirement plan and tax-sheltered annuity plan • Subsidized Massachusetts Bay Transportation Authority (MBTA) passes • Employee perks - enjoy discounts on tickets and passes for everything from ski resorts to museums to sporting events. Job Summary Manage and oversee storage and quality control of radiation treatment plans using the MiM software for the M3 Collaboration. Interface with participating institution’s dosimetry and physics teams to facilitate radiation plan and diagnostic imaging transfers while serving as primary contact for MiM personnel and other dosimetry teams under the M3 Collaboration. Develop and perform treatment plan quality control procedures within MiM to monitor treatment planning data sent from participating sites. Identify and contour normal and dose-limiting structures using AI-supported tools in MiM by utilizing images from one or more data sets. Utilize scripting and workflows in MiM for creation of composite plans and data quality control and extraction. Meet weekly with research teams and researchers from a variety of disciplines and backgrounds towards fulfillment of M3 Collaboration’s aspirations. Maintain and enhance knowledge of both proton and photon (3DCRT, IMRT, VMAT, SBRT) treatment planning techniques, delivery, and software with a specific focus for pediatric patients. Participate in continuing education and quality improvement processes in support of this knowledge development. Aid in orientation and education activities for members of the M3 Collaboration as needed. Qualifications Education Bachelor’s degree in physics (or a related Life, Physical, or Applied Science) is required. JRCERT-accredited Formal Education in Medical Dosimetry (BS/MS/Certificate) is preferred. Can this role accept experience in lieu of a degree? No Licenses and Credentials Medical Dosimetrist Certification Board (MDCB) eligibility is required, while MDCB certification is preferred. Experience Clinical medical dosimetry experience, including 3D conformal and IMRT/VMAT/SBRT treatment planning or basic Proton treatment planning 3-5 years required Knowledge, Skills and Abilities - Knowledgeable in the areas of anatomy, physiology, clinical oncology, radiobiology, radiation physics, and radiation safety. - Expertise in the technical aspects of radiation oncology and medical physics to develop optimal treatment plans, with experience working with pediatric radiation treatment plans preferred but not required. - Detailed knowledge of MiM Maestro radiation oncology software, with particular focus on treatment plan manipulation, storage software methodologies, and expertise in creating scripting/workflows within MiM. - Knowledgeable in health care informatics-including the resources, devices, and methods to acquire, store and retrieve data. Tools include computers as well as clinical guidelines, current medical terminology, information, and communication systems. - Possess good communication and interpersonal skills to facilitate the exchange of information with all research members of the M3 Collaboration, including doctors, registered nurses, data engineers, bioinformaticians, biostatisticians, clinical research coordinators, and program and project managers. - Has high level critical thinking and problem-solving skills and can work both independently and in collaboration with other professionals. - Willingness to work on related items to forward the mission of the M3 Additional Job Details (if applicable) Physical Requirements - Standing Frequently (34-66%) - Walking Frequently (34-66%) - Sitting Occasionally (3-33%) - Lifting Frequently (34-66%) 35lbs+ (w/assisted device) - Carrying Frequently (34-66%) 20lbs - 35lbs - Pushing Occasionally (3-33%) - Pulling Occasionally (3-33%) - Climbing Rarely (Less than 2%) - Balancing Frequently (34-66%) - Stooping Occasionally (3-33%) - Kneeling Occasionally (3-33%) - Crouching Occasionally (3-33%) - Crawling Rarely (Less than 2%) - Reaching Frequently (34-66%) - Gross Manipulation (Handling) Frequently (34-66%) - Fine Manipulation (Fingering) Frequently (34-66%) - Feeling Constantly (67-100%) - Foot Use Rarely (Less than 2%) - Vision - Far Constantly (67-100%) - Vision - Near Constantly (67-100%) - Talking Constantly (67-100%) - Hearing Constantly (67-100%) Remote Type Remote Work Location 45 Fruit Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $118,435.20 - $172,234.40/Annual Grade 8 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.