Clinical research associate jobs in Smithtown, NY

Clinical Research Associate I Required Qualifications (as evidenced by an attached resume):Bachelor's degree (foreign equivalent or higher). In lieu of a Bachelor's degree, a combination of clinical/healthcare, medical type industry setting and/or human research experience totaling four (4) years full-time may be considered. Two (2) years of full-time research experience. One (1) year of full-time human research experience. Knowledge of medical terminology. Preferred Qualifications: Experience coordinating clinical trials in Oncology. Previous use of e-regulatory systems and Clinical Trial Management Systems. Direct experience with IRB submissions to BRANY and Stony Brook IRB. Prior experience entering data in REDCap database. Proficiency with Microsoft Word, Excel and/or PowerPoint.Brief Description of Duties:At Stony Brook Medicine, a Clinical Research Associate is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital. Qualified candidates will demonstrate superior patient care and possess outstanding communication skills while adhering to our high standard of excellence. The successful incumbent will have excellent communication and organizational skills. Duties:Prepares and submits protocols and supporting documents to the IRB of record for approval and the local IRB for acknowledgment, including submission of continuations and amendments, as necessary to maintain compliance with NCI requirements, GCP guidelines, and institutional policies. Responds to all questions from the IRB related to the regulatory aspects of the study.Creates and maintains files and documentation pertaining to regulatory requirements for clinical trials.Obtain consent from research subjects.Create research records (e.g. a research binder) for each participant by chart review for the duration of the study, as either physical and/or electronic records.Maintain a working knowledge of the research plan, and explain the study procedures and expectations to prospective participants.Enter study data in REDCap timely and accurately, and transmit imaging data to sponsor. Completion of data case report forms both paper and electronic. Document screening, eligibility, data collection, completion of Case Report Forms and all regulatory requirements per protocol.Maintain Informed Consent file versions, and other study documentation.Ensure appropriate patient follow-up as required by protocol.Other duties or projects as assigned.Special Notes:The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.For this position, we are unable to sponsor candidates for work visas.Resume/CV and cover letter should be included with the online application.Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at ************** or visit OEA.In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here.Visit our WHY WORK HERE page to learn about the total rewards we offer.SUNY Research Foundation: A Great Place to Work.The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting. Job Number: 2504218Official Job Title: Clinical Research Associate IJob Field: Research Professional / TechnicalPrimary Location: US-NY-Stony BrookDepartment/Hiring Area: PathologySchedule: Per Diem Shift :Variable Shift Hours: 8:30 am - 5:00pm Posting Start Date: Dec 2, 2025Posting End Date: Dec 17, 2025, 4:59:00 AMSalary:60,000 - 65,000Appointment Type: RegularSalary Grade:E99SBU Area:The Research Foundation for The State University of New York at Stony Brook

Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinical research nurses and team. Responsibilities Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols. Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team. Ensure compliance with the Good Clinical Practice guidelines in clinical research. Monitor study patients for adverse events in collaboration with clinical team and report as required. Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements. Qualifications Education requirement: BS Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments. Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.

Job Description The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with overall study execution. The CRA may also assist with data management, vendor management and site monitoring as needed. Duties and Responsibilities Act as the primary point of contact with assigned clinical study sites during start-up activities; Working with finance and legal experts, drive contract and budget negotiations (or amendments) with assigned sites; Review site-level documents needed for IRB/EC/REC approval; Support study initiation, monitoring, audit and close-out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan; Ensure clinical study site documentation compliance according to GCPs, ICH and FDA regulations; Provide relevant, timely study subject updates to the Clinical Study Manager(s) (e.g., upcoming treatment dates, subject withdrawals, etc.); Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors; Collaborate with clinical study site and sponsor to troubleshoot and provide appropriate solutions to study-related issues, as appropriate; Assist in patient recruitment activities; Assist with the development of study-related documents as requested; Prepare accurate and timely study reports as requested; Work independently and under general supervision. Education Bachelor's degree (or higher) in nursing, health sciences or related field; Qualifications Experience with clinical trial contract and budget negotiations Finance experience preferred Minimum of two years of CRA experience, with clinical site monitoring experience preferred; Strong oral and written communication skills; Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance; Proven organizational skills and the ability to manage multiple priorities; Strong computer skills; Ability to travel with adequate prior notification Powered by JazzHR pc6irHPzE6

Your work will change lives. Including your own. The Impact You'll Make Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a highly motivated and skilled Senior Clinical Project Manager within our Clinical Operations team who will manage the conduct and execution of one or more clinical trials from study start-up to study closure with support or direction from a Director of Clinical Operations. In this role, you will: Lead all aspects of clinical trial execution for one or more programs from IND through proof-of-concept and pivotal studies Plan and oversee implementation, coordination, and execution of global clinical trials including, but not limited to, oversight of study budgets, financial reporting, and forecasting in collaboration with Clinical Outsourcing Develop and maintain strong relationships with cross-functional study teams, CROs, clinical investigators, and clinical trial stakeholders Manage clinical trial operations and lead study teams, including CROs and vendors, and reporting of start-up, conduct, and close-out activities Ensure compliance with study protocol and applicable Standard Operating Procedures (SOP), Good Clinical Practices (GCP), ICH and local regulations The Team You'll Join Reporting to a Director of Clinical Operations, you will be an essential member of the Clinical Operations team within Development. This team is dedicated to ensuring operational excellence across our clinical programs.The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion's innovative science to patients through clinical development activities. The Experience You'll Need Bachelor's degree in a scientific or healthcare-related field 7+ years of experience in a clinical operations role in the biopharmaceutical industry, with at least 3+ years experience in a clinical project management role within a biotech organization required Early phase (Phase 1, 2) oncology experience at a biotech/Sponsor is required Demonstrated experience organizing and leading clinical study teams Preferred Skills: proficiency managing timelines, tasks, milestones working in SmartSheet or similar project management software Demonstrated track-record of efficient and effective clinical trial planning and execution, including risk management and mitigation strategies Experience in vendor and CRO selection,management, and oversight Experience managing and tracking study budgets and financials with participation and involvement with invoice and contract review and approvals Experience working closely with data management and clinical teams to set up study systems and ensure quality data collection through monitoring, cleaning and analysis Preferred: CRF development and IRT build experience, knowledge of data listings used for monitoring and cleaning, contribution to data management related plans and specifications Excellent working knowledge of FDA, ICH, GCP regulations and guidelines Willingness and ability to travel to sites, conferences and Recursion offices as needed Working Location & Compensation: This position is ideally based at our office located in New York City, but may also be located in our Salt Lake City headquarters. Please note that we are a hybrid environment and ask that employees spend 50% of their time in the office. Relocation support can be provided for this role. At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $168,000 to $204,800 (USD). You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package. #LI-DB1 The Values We Hope You Share: We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust. We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action. We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection. We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day. We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together. We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities. Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively. More About Recursion Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine. Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn. Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation. Accommodations are available on request for candidates taking part in all aspects of the selection process. Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.

Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinical research nurses and team. Responsibilities Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols. Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team. Ensure compliance with the Good Clinical Practice guidelines in clinical research. Monitor study patients for adverse events in collaboration with clinical team and report as required. Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements. Qualifications Education requirement: BS Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments. Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.

Required Qualifications (as evidenced by an attached resume): Bachelor's degree (foreign equivalent or higher). In lieu of a Bachelor's degree, a combination of clinical/healthcare, medical type industry setting and/or human research experience totaling four (4) years full-time may be considered. Two (2) years of full-time research experience. One (1) year of full-time human research experience. Knowledge of medical terminology. Preferred Qualifications: Experience coordinating clinical trials in Oncology. Previous use of e-regulatory systems and Clinical Trial Management Systems. Direct experience with IRB submissions to BRANY and Stony Brook IRB. Prior experience entering data in REDCap database. Proficiency with Microsoft Word, Excel and/or PowerPoint. Brief Description of Duties: At Stony Brook Medicine, a Clinical Research Associate is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital. Qualified candidates will demonstrate superior patient care and possess outstanding communication skills while adhering to our high standard of excellence. The successful incumbent will have excellent communication and organizational skills. Duties: * Prepares and submits protocols and supporting documents to the IRB of record for approval and the local IRB for acknowledgment, including submission of continuations and amendments, as necessary to maintain compliance with NCI requirements, GCP guidelines, and institutional policies. Responds to all questions from the IRB related to the regulatory aspects of the study. * Creates and maintains files and documentation pertaining to regulatory requirements for clinical trials. * Obtain consent from research subjects. * Create research records (e.g. a research binder) for each participant by chart review for the duration of the study, as either physical and/or electronic records. * Maintain a working knowledge of the research plan, and explain the study procedures and expectations to prospective participants. * Enter study data in REDCap timely and accurately, and transmit imaging data to sponsor. * Completion of data case report forms both paper and electronic. * Document screening, eligibility, data collection, completion of Case Report Forms and all regulatory requirements per protocol. * Maintain Informed Consent file versions, and other study documentation. * Ensure appropriate patient follow-up as required by protocol. * Other duties or projects as assigned. Special Notes: The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption. For this position, we are unable to sponsor candidates for work visas. Resume/CV and cover letter should be included with the online application. Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws. If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at ************** or visit OEA. In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here. Visit our WHY WORK HERE page to learn about the total rewards we offer. SUNY Research Foundation: A Great Place to Work. The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting. '725278

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and comply with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities * Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. * Demonstrate compliance with procedures and be accountable for compliance of team members. * Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. * Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management. * Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. * Collaborate with Global Patient Safety on risk management planning. * Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. * Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. * Participate in data analysis, scientific dissemination, and preparation of final study reports. * Analyze and contextualize clinical data to support decision-making and portfolio strategy. * Contribute to strategic planning and innovation through cross-functional working groups. * Support planning and execution of symposia, advisory boards, and other external engagements. * Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. * Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development * Stay current with medical literature and scientific developments in breast oncology. * Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. * Provide scientific consultation to medical affairs, health outcomes, and commercial teams. * Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development * Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. * Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: * PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience * 3+ years of clinical research scientist experience/clinical trial experience * Direct Line Leadership experience Additional Information/Preferences: * Breast cancer disease state knowledge/experience * An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) * Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. * Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills * Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment. * Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. * Fluent in English, verbal and written communication Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people. At Ascensia, our values serve as the bedrock of our organization. They guide our decisions, actions, and interactions, shaping the culture we collectively foster. Our Values include: Resilient Growth Mindset Executional Excellence Courageous Leadership Inclusive Collaboration We believe that when we live our values authentically, both individually and as a team, we unlock our true potential and drive sustainable success. POSITION PURPOSE: Under the supervision of the Internal Clinical Trials (ICT) manager, this position will plan and perform laboratory experiments and internal clinical studies to develop new products and support existing products in the Ascensia Diabetes Care portfolio. Expertise will be provided not only for new product development, but also for external publication, regulatory submissions, and sustaining products in the commercial phase. This position will also provide support to Global Event Management (GEM) laboratory testing needs, including management of customer complaint databases. What you will be doing: Conduct internal clinical studies across all phases of new product development and sustainment, including frequent subject sampling via fingerstick and venipuncture. Support project teams with exploratory and feasibility testing. Perform experiments using both contrived and native human blood samples, ensuring all procedures and results are accurately documented. Analyze, interpret, and report testing results clearly and concisely, providing logical recommendations for next steps. Serve as the primary analyst for blood glucose investigations requiring fresh donor blood, including receipt, logging, and laboratory evaluation of returned products. Manage the customer complaint database by creating, reviewing, and authoring test instructions for complaint evaluations. Operate and maintain laboratory equipment, including clinical reference instrumentation, ensuring ongoing compliance with maintenance and audit requirements. Adhere to Good Clinical Practice (GCP) principles at all times. Collaborate professionally with scientific colleagues to stay informed of relevant research and company initiatives. Protect the confidentiality of participant health information. Perform administrative duties as needed, including report filing, invoice submission, and coordination of biohazard waste disposal. What you need for success: Bachelor's degree (BS or BS in Medical Laboratory Science) with a minimum of 4 years of relevant experience, or a Master's degree (MS) with at least 2 years of relevant experience. Phlebotomy experience required; certification preferred. Experience in the medical device or pharmaceutical industry preferred. Strong oral and written communication skills in English required. Demonstrated ability to collaborate effectively within multidisciplinary scientific teams. Proven competency in experimental design, execution, and data interpretation. TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third-party resumes. Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Position Overview:** The **Development Clinical Research Scientist** (CRS) in the **Breast Cancer Franchise** will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and comply with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. **Primary Responsibilities** + Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. + Demonstrate compliance with procedures and be accountable for compliance of team members. + Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. + Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management. + Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. + Collaborate with Global Patient Safety on risk management planning. + Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. + Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. + Participate in data analysis, scientific dissemination, and preparation of final study reports. + Analyze and contextualize clinical data to support decision-making and portfolio strategy. + Contribute to strategic planning and innovation through cross-functional working groups. + Support planning and execution of symposia, advisory boards, and other external engagements. + Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. + Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. **Scientific & Technical Expertise and Development** + Stay current with medical literature and scientific developments in breast oncology. + Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. + Provide scientific consultation to medical affairs, health outcomes, and commercial teams. + Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. **Leadership & Professional Development** + Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. + Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. **Basic qualifications:** + PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience + 3+ years of clinical research scientist experience/clinical trial experience + Direct Line Leadership experience **Additional Information/Preferences:** + Breast cancer disease state knowledge/experience + An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) + Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. + Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills + Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment. + Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. + Fluent in English, verbal and written communication Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

Job Description The START Center for Cancer Research (“START”) is the world's largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START's mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population - leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many - by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most. START represents the world's largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda - the most effective cancer drug in medical history. We are hiring a Clinical Research Coordinator, RN, for our START New York - Long Island location. The Clinical Research Coordinator, RN supports early phase oncology trials under senior research staff guidance. This role ensures accurate, timely research conduct, adhering to protocols, regulatory standards, and patient safety. Responsibilities include direct patient interaction, data collection, maintaining Good Clinical Practice (GCP), overseeing multiple protocols, and coordinating patient participation. The CRC, RN implements and completes protocol requirements, ensuring accurate, up-to-date information is provided to the team. Address: 450 Lakeville Road, Lake Success, NY 11042 Schedule: Monday through Friday, 8:00am - 5:00pm This role offers a competitive hourly rate of $60-$75, based on experience and qualifications, along with an annual bonus opportunity of 10%.Essential Responsibilities: Communicate regularly with Study Sponsors, CROs, and staff regarding protocol status, questions, and concerns. Monitor day-to-day study conduct to ensure protocol, SOP, and Good Clinical Practice compliance. Review and create trial forms to ensure protocol compliance. Maintain organized study files with standardized labeling and filing procedures. Implement protocols and amendments, training staff on patient treatment and management. Assist with patient screening, eligibility determination, and informed consent process. Manage source documents, address protocol deviations, assist with case report forms, and submit Serious Adverse Event reports. Education & Experience: Associate's degree in Nursing and RN license in state of Michigan. 2 years of clinical research experience, with a basic understanding of oncology Phase 1 trials. Strong attention to detail, accuracy in data collection, and ability to meet deadlines. Excellent organizational, time-management, and communication skills. Proficient in Microsoft Office Suite, clinical trial management software, and knowledge of GCP and regulatory requirements. Preferred Education and Experience: Bachelor's degree in Nursing. Experience working in an oncology setting. More about The START Center for Cancer Research Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including 43 therapies that were approved by the FDA. START represents the world's largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community- eligible for opportunities through the New Haven Hiring Initiative or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale! Salary Range $65,000.00 - $101,000.00 Overview Within the Department of Neurology's Clinical Research Office and reporting to the Research manager, the Clinical Research Coordinator (CRC) will lead efforts in the execution of research studies within the scope of the established study protocol(s) assigned. These activities include, but are not limited to, study start up, patient screening, eligibility determination, registration and other protocol and subject milestones. The CRC will also be the primary point of contact on all communications and management of all study documentation. The CRC will have direct patient contact and will be responsible for managing all clinical trials primarily in the Neuroimmunology Division. Some studies may require on call rotational support on weekends/after normal business hours. Subjects will be recruited in both the New Haven and North Haven campus but may be recruited from other Yale Neurology locations within the state of Connecticut. Required Skills and Abilities 1. Excellent verbal and written communication skills, with demonstrated outstanding organizational and time management skills. Ability to independently prioritize tasks with competing deadlines and priorities. 2. Demonstrated skill in careful attention to study requirements, regulatory compliance and accuracy in follow through. Ability to prepare and submit regulatory documents and maintenance documents for the life of the research study/trial. 3. Skilled in obtaining informed consent and related research subject interactions and requirements, including working with clinical providers to support the study. Proven ability to track multiple occurrences and outcomes and document in a timely manner. 4. Demonstrated independence and management skills including critical thinking and problem solving to ensure effective study execution and compliance with sponsor policies. 5. Exemplary time and attendance. Ability to be flexible in schedule to attend to study needs and subject recruitment and work as a team with other clinical research coordinators. Preferred Education, Experience and Skills 1. Master's degree in health or research related discipline and two years of related work experience in a similar job family. 2. Strongly prefer candidates with a demonstrated ability to work with minimal supervision in a team atmosphere and receptiveness to direction and new processes. 3. Familiarity with neurological clinical research strongly preferred. 4. Proven experience in EPIC and OnCore systems and IRB submissions. Preferred Licenses or Certifications 1. Certified Clinical Research Professional (CCRP) or equivalent. Principal Responsibilities 1. Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols. 2. Documents established congruency between funding proposals and approved protocols. 3. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols. 4. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner. 5. Attends meetings and presents issues when necessary that were identified during congruency review. 6. Serves as a resource and provides technical assistance to investigators and their staff. 7. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed. 8. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements. 9. Develops, implements, and manages internal practices that ensure compliance with federal requirements. 10. May perform other duties as assigned. Required Education and Experience Bachelor's degree in a relevant academic/scientific field and a minimum of 3 years of related research support experience; or the equivalent combination of education or experience. Job Posting Date 12/05/2025 Job Category Manager Bargaining Unit NON Compensation Grade Administration & Operations Compensation Grade Profile Supervisor; Senior Associate (23) Time Type Full time Duration Type Staff Work Model Hybrid Location 2 Church Street South, New Haven, Connecticut Background Check Requirements All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website. Health Requirements This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air. HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination. Posting Disclaimer Salary offers are determined by a candidate's qualifications, experience, skills, and education in relation to the position requirements, along with the role's grade profile and current internal and external market conditions. The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the position. Employees will be assigned specific job-related duties through their hiring department. The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual's sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran. Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA). Note Yale University is a tobacco-free campus.

Founded in 1964, New York Blood Center (NYBC) has served the tri-state area for more than 60 years, delivering 500,000 lifesaving blood products annually to 150+ hospitals, EMS and healthcare partners. NYBC is part of New York Blood Center Enterprises (NYBCe), which spans 17+ states and delivers one million blood products to 400+ U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200+ research, academic and biopharmaceutical organizations. NYBCe's Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. NYBC serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit nybc.org. Connect with us on Facebook, X, Instagram, and LinkedIn. Responsibilities This position is responsible for overseeing and managing the daily activities of Clinical Trials. Execute recruitment efforts for various clinical trials. Ensure recruitment to meet study goals. Coordinate efforts and activities with NMDP(National Marrow Donor Program), and Clinical Services departments. Manage activities of consented participants for studies, including arranging physical exams, blood draws, etc. Assure completion and appropriate filing of all study documentation. Communicate all clinical trial activities to supervisor and other members of NMDP(National Marrow Donor Program) and Comprehensive Cell Solutions staff, preparing reports as necessary. Obtain informed consent and maintain documentation. Schedule and manage participant visits and study-related procedures. Communicate study updates and issues to the research team and management. Coordinate collection, processing, and shipment of biological samples per protocol requirements. Makes recommendations to improve business unit operations. Attends meetings as necessary. Any related duties as assigned. Qualifications Education: Bachelor's Degree in health services administration, health sciences, public administration or public health or related area. Experience: Three years of experience in a health-related field. Knowledge: Knowledge of computerized systems and applications (Microsoft Office). Skills: Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds. High level of interpersonal skills to handle a variety of moderate issues and situations. Position requires demonstrated poise, tact and diplomacy in dealing with a variety of staff up to and including executive leadership. Attention to detail in all work processes. Abilities: Ability to analyze processes and procedures. Ability to read and understand laboratory protocols and SOPS and assess implications for study execution. Ability to communicate clearly and with authority, both in writing and verbally, to others in one-on-one or small group settings. Ability to interact with individuals at all levels of the organization and customers in a helpful, courteous and friendly manner while demonstrating sensitivity to and respect for diverse populations. Ability to plan and organize job tasks or resources in an efficient manner. Ability to be responsive and available to management in order to address issues and concerns as they arise. Any combination of education, training and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job. For applicants who will perform this position in New York City or Westchester County, the proposed hiring rate is $33.52p/hr. to $35.00p/hr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant's skills, job-related knowledge, and experience. Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations.

Participate and coordinate in clinical research studies conducted by supervising physician. Perform a variety of administrative duties to assist in the conduct of research trials. Supervises data manager and interns. Responsible for study initiation, subject recruitment, follow-up, data management, detailed record keeping and regulatory compliance, report writing, and correspondence with investigators, sponsors/CROs, IRBs, and regulatory authorities. Responsible for the new submission of protocols with subsequent amendments. Some participation in protocol writing. Educate research subjects, physicians, nurses, and ancillary staff on available research studies, study treatment/ required activities, and use/ side effects of investigational study drug. Responsible for initial and continuing education for Good Clinical Practice compliance. * Review institutional review board approved protocol and protocol documents prior to study activation and patient enrollment. * Coordinate Study feasibility and initiation. * Review patient charts, database records, and other sources to screen and identify potential subjects for inclusion in a study. * Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate. * Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records and coordinating the collection and shipments of specimens as required by protocol. * Communicates study objectives and procedures to all relevant hospital units involved with the study, including the establishment of good rapport with the Principal Investigator and providing him/her with the required assistance. * Communicates with the Sponsor or its representatives, schedules and facilitates study Monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor's representatives. * Educate physicians, nurses, and ancillary staff regarding investigational product, trial activities, and requirements. * Meet with potential subjects and their families to explain trial and treatment plan, and provide emotional and educational support. * Collect pertinent information and data from study subject interviews, charts, study electronic devices and other sources. * Meet with study sponsor and regulatory representatives to review and discuss conduct of the trial. * Interacts with patients and families to ensure compliance with the protocol. * Obtain written informed consent for subject to participate in trial prior to performing any study-related procedures. * Coordinate research activities, including schedule appointments, laboratory tests, radiology and cardiology testing. * Assists with maintaining accurate records of the receipt, inventory, and dispensation of study drug and materials. * Assists the Director and Manager with protocol evaluation and feasibility. * Responsible for speedy and adequate patient enrollment in all assigned studies and reflective of meeting department goals as proportionate to studies assigned. * Compile and submit reports, documents, and correspondence to trial sponsor, institutional review board, and regulatory agencies. * Oversees or submits new protocols to IRB and verifies that the proper document was received. In addition, submits amendments of protocols to IRB and verifies that the required corrections were inserted following the established procedures. * Trains less experienced team members. * Complete protocol required case report forms accurately, completely, and in a timely manner in Electronic Data Capture system or paper format. * Prepare or oversee the preparation of biologic specimens for shipment to study reference laboratory. * Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. Follows Stamford Hospital's Standard Operating Procedures, AAHRPP, HIPPA, and FDA guidelines for clinical research, keeps updated with those procedures and/or guidelines, and complies with finance compliance policies and procedures. * Responsible for the interdepartmental technical logistics for Device and Facility Use studies. * Bachelor's Degree in scientific field preferred or a BA and 3 years research experience * Clinical research certification (such as CCRC, CCRP or other certification approved by Director) preferred. If not yet certified, expected certification within 18-24 months of hire date. * Human Research Subject Protection and Good Clinical Practice Certification * OSHA training for handling hazardous biologic and chemical materials

Participate and coordinate in clinical research studies conducted by supervising physician. Perform a variety of administrative duties to assist in the conduct of research trials. Supervises data manager and interns. Responsible for study initiation, subject recruitment, follow-up, data management, detailed record keeping and regulatory compliance, report writing, and correspondence with investigators, sponsors/CROs, IRBs, and regulatory authorities. Responsible for the new submission of protocols with subsequent amendments. Some participation in protocol writing. Educate research subjects, physicians, nurses, and ancillary staff on available research studies, study treatment/ required activities, and use/ side effects of investigational study drug. Responsible for initial and continuing education for Good Clinical Practice compliance. Bachelor's Degree in scientific field preferred or a BA and 3 years research experience Clinical research certification (such as CCRC, CCRP or other certification approved by Director) preferred. If not yet certified, expected certification within 18-24 months of hire date. Human Research Subject Protection and Good Clinical Practice Certification OSHA training for handling hazardous biologic and chemical materials Review institutional review board approved protocol and protocol documents prior to study activation and patient enrollment. Coordinate Study feasibility and initiation. Review patient charts, database records, and other sources to screen and identify potential subjects for inclusion in a study. Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate. Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records and coordinating the collection and shipments of specimens as required by protocol. Communicates study objectives and procedures to all relevant hospital units involved with the study, including the establishment of good rapport with the Principal Investigator and providing him/her with the required assistance. Communicates with the Sponsor or its representatives, schedules and facilitates study Monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor's representatives. Educate physicians, nurses, and ancillary staff regarding investigational product, trial activities, and requirements. Meet with potential subjects and their families to explain trial and treatment plan, and provide emotional and educational support. Collect pertinent information and data from study subject interviews, charts, study electronic devices and other sources. Meet with study sponsor and regulatory representatives to review and discuss conduct of the trial. Interacts with patients and families to ensure compliance with the protocol. Obtain written informed consent for subject to participate in trial prior to performing any study-related procedures. Coordinate research activities, including schedule appointments, laboratory tests, radiology and cardiology testing. Assists with maintaining accurate records of the receipt, inventory, and dispensation of study drug and materials. Assists the Director and Manager with protocol evaluation and feasibility. Responsible for speedy and adequate patient enrollment in all assigned studies and reflective of meeting department goals as proportionate to studies assigned. Compile and submit reports, documents, and correspondence to trial sponsor, institutional review board, and regulatory agencies. Oversees or submits new protocols to IRB and verifies that the proper document was received. In addition, submits amendments of protocols to IRB and verifies that the required corrections were inserted following the established procedures. Trains less experienced team members. Complete protocol required case report forms accurately, completely, and in a timely manner in Electronic Data Capture system or paper format. Prepare or oversee the preparation of biologic specimens for shipment to study reference laboratory. Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. Follows Stamford Hospital's Standard Operating Procedures, AAHRPP, HIPPA, and FDA guidelines for clinical research, keeps updated with those procedures and/or guidelines, and complies with finance compliance policies and procedures. Responsible for the interdepartmental technical logistics for Device and Facility Use studies.

Job DescriptionBenefits: 401(k) 401(k) matching Competitive salary Dental insurance Health insurance Paid time off Profit sharing Vision insurance Ki Health Partners, LLC Location: Stamford, CT Ki Health Partners, LLC is a growing, patient-centered clinical research organization dedicated to advancing quality healthcare through innovative clinical studies. We are seeking a highly organized and motivated Clinical Research Administrative Assistant to join our team and support daily operations across multiple service lines and clinical trials. Position Overview The Clinical Research Administrative Assistant will play a key role in supporting clinical research staff, coordinating documentation, maintaining regulatory compliance, and facilitating smooth study operations. This role is ideal for a detail-oriented professional who thrives in a dynamic, mission-driven environment. Key Responsibilities Provide administrative and operational support to the clinical research team Assist with study documentation, regulatory filing, and maintenance of trial master files Schedule patient visits, monitor calendars, and coordinate communication between staff, sponsors, and participants Maintain accurate data entry in clinical databases and tracking systems Support IRB submissions, study start-up activities, and ongoing regulatory compliance Prepare study materials, forms, and reports as needed Ensure confidentiality and adherence to Good Clinical Practice (GCP) guidelines Tracking staff training expiration dates and assisting in collecting updated documentation Ensuring proper version control of study documents (ICFs, protocol, worksheets, recruitment materials) Distributing meeting notes, reminders, and updated study documents to the research team Coordinating team calendars, meetings, and training sessions Qualifications Strong organizational skills and attention to detail Excellent written and verbal communication Ability to manage multiple tasks in a fast-paced environment Proficiency with Microsoft Office and general administrative software Prior experience in healthcare, research, or administrative roles preferred Familiarity with clinical trials or GCP guidelines is a plus Why Join Ki Health Partners? Opportunity to contribute to meaningful research that impacts patient care Supportive, collaborative team environment Professional growth and training opportunities Competitive compensation package If you are passionate about healthcare, research, and making a positive impact, we encourage you to apply! To Apply: Please send your resume and a brief cover letter to Patti Mennona, HR Manager (***************) with the subject line: Clinical Research Administrative Assistant Application .

Qualifications Bachelor's degree required. EMT certification or a minimum of 1 year working in a medical office. AHA BLS / ACLS upon hire. Minimum of one (1) year full-time experience in a pre-hospital or hospital setting. Ability to evaluate multiple data elements and interpret those data elements in real-time. Excellent verbal communication skills, including telephone skills and the ability to effectively communicate with patients, patient families, clinical and non-clinical staff, and explain rationale for decisions clearly and effectively.

Job Description Pay Range: $20.00 to $27.50 an hour. By adhering to Connecticut State Law, pay ranges are posted. The pay rate will vary based on various factors including but not limited to experience, skills, knowledge of position and comparison to others who are already in this role within the company. Summary: The primary responsibility of the role is to support the quality department programs. Essential Functions: Assists Manager and others in the Quality Department in recognizing unmet needs within the organization and assists in planning and development of corrective actions Works closely with the divisions to implement and maintain the set quality work standards by providing training to managers and employees on appropriate workflows Helps facilitate aspects of the patient safety programs in conjunction with the Safety Coordinator regarding our Environment of Care processes and other policies and procedures relating to patient safety Utilize EMR to run reports as requested by Manager and/or Quality APRN Assist Quality Manager with report reviews and workflow discoveries in regards to Quality measures Assist and become familiar with Patient Centered Medical Home certification and standards Will be expected to assist in projects involving documentation and chart updates if missing appropriate documentation Attends Quality and Safety meetings and participates on appropriate committees Skills and Knowledge: Excellent oral and written communication skills. Excellent analytical skills. High degree of initiative, judgment and discretion. Ability to coach other staff members, while simultaneously functioning as member of a team. Proven ability to integrate priorities and deadlines. Must function well under pressure, with the ability to multitask, paying close attention to detail. Education and Experience: Medical Assistant program completed Medical Assistant experience required at least 3 years Proficient in Microsoft Office (Word, Power Point, Excel and Outlook) Strong communication and collaboration skills working with providers and staff Demonstrated performance in meeting time-sensitive deadlines with minimal supervision Outgoing personality and enthusiasm to teach Enthusiasm for working with a large diverse clinical team in an expansive practice

The Communication Sciences & Disorders Department at Iona University welcomes applicants for a Clinic Coordinator. The Clinic Coordinator will report to the Speech, Language and Hearing Clinic Director to support and supervise daily office operations for the Iona University Speech, Language and Hearing Clinic. The successful candidate will have strong operational and organizational skills, be detail-oriented, and be able to manage multiple responsibilities in a fast-paced clinical and academic setting. This role requires advanced customer service, data management, problem-solving, and interpersonal and communication skills to enhance our student and client experiences. The successful candidate should have the ability to balance clinic operations with general Clinic department support, shifting between tasks and priorities while maintaining a high level of professionalism and accuracy. This position will also provide general administrative support to the Department of Communication Sciences and Disorders and report to the Department Chair for those responsibilities. Bilingual candidates are preferred. Key Responsibilities * Oversees the administrative operations of the Speech, Language, and Hearing Clinic, including scheduling, communications, documentation management, and coordination of clinic activities to ensure efficient daily operations. * Manages, processes, and tracks billing and payments, ensuring accuracy in invoicing and reconciliation of payments * Supports and manages student and staff portfolios, including maintaining accurate and up-to-date records of clinical assignments, supervision schedules, certifications, compliance documents, and professional development tracking. * Serves as the primary point of contact for clients, students, and clinical staff, providing high-quality customer service and ensuring clear, professional communication across all stakeholders. * Coordinates and maintains clinic schedules for student clinicians and supervisors; assists with posting and communicating updates, changes, and coverage needs. * Responds promptly and professionally to phone calls and emails, routing inquiries appropriately and maintaining confidentiality in compliance with HIPAA and FERPA standards. * Supports onboarding, training, and troubleshooting for the Clinic's Electronic Medical Record (EMR) system; assists users and generates reports as needed. * Oversees and supervises student workers assigned to the clinic, including scheduling, task assignment, and training to ensure adherence to clinic policies and procedures. * Coordinates communication and collaboration with other university departments (e.g., Registrar, Finance, Facilities, IT, and HR) to support clinic operations and problem resolution. * Supports departmental needs including but not limited to: * Manage and facilitate communications between department, students, and alumni * Assist with graduate student recruitment and follow-up * Assist with certification paperwork for graduate students * Maintain paperwork and provide support for graduate program accreditation, departmental grants, faculty developmental paperwork, and grant budgets * Assists with routine financial and administrative operations, including purchasing, expense tracking, and basic budget management for the clinic and department. * Assist with planning and supporting department-wide events Professional Attributes * Professionalism and discretion in all communications and interactions. * Ability to work collaboratively within a multidisciplinary team. * Initiative in identifying and implementing process improvements. * Commitment to supporting the mission and values of Iona University and the Department of Communication Sciences and Disorders.

Job Description Mission QSAC is a New York City and Long Island based nonprofit that supports children and adults with autism, together with their families, in achieving greater independence, realizing their future potential, and contributing to their communities in a meaningful way by offering person-centered services. QSAC pursues this mission through direct services that provide a supportive and individualized setting for children and adults with autism to improve their communication, socialization, academic, and functional skills "Urgently Hiring!! Looking to fill as soon as possible!!" Salary for this position is $62,000-$70,000 annually Job Summary Make recommendations to Behavior Intervention Specialists for clinical interventions. Train, guide and supervise staff in using the principles of Applied Behavior Analysis. Collaborate with Behavior Intervention Specialists to conduct functional behavior assessments. Work with BIS's to develop behavior support plans and data collection systems. Review day habilitation plans, behavior support plans, goals, and progress notes. Participate in the ISP process and goal development. Review and maintain documentation and provide reports to supervisors. Assist Behavior Intervention Specialists in conducting in-service trainings. Develop training protocols and provide staff training across all sites Provide training and support to Behavior Intervention Specialists for development of proactive and reactive strategies/SCIP-R interventions and implementation Punctuality and regular attendance is expected. Maintain individual/family confidentiality. Travel across all Day Hab sites in assigned region, at times traveling to sites outside of the region. Complete required QSAC orientation. Ensure health, safety & welfare of individuals Commitment to company values and adherence to policies. Perform other duties as assigned by supervisors and/or senior management. MINIMUM QUALIFICATIONS A Master's Degree in Special Education, Psychology, or a related field. BCBA preferred. Experience in Applied Behavior Analysis and working with individuals with Autism Spectrum Disorders. Experience in working with the adult developmental disabilities population. Knowledge and experience in the development of data-based curriculum goals and the ability to develop behavior intervention plans based on functions of behavior. Minimum of two years' experience either working directly with individuals with autism spectrum disorders and/or adults with intellectual & psychiatric disorders or supervising Behavior Intervention Specialists, lead teachers, supervisors, consultants and/or equivalent position. Knowledge and experience conducting parent/family/caregiver/staff training. Must be proficient in Microsoft Word and Excel. Must be able to travel across QSAC sites. Ability to run. Ability to safely assist lifting individuals of various weights & 20 lb items. Clearance through state mandated Background/Fingerprint Check(s). Ability to communicate effectively with others and individuals served. Benefits QSAC has terrific benefits that go beyond health and retirement. You will be joining a passionate community of professionals and staff who support each other in a challenging and rewarding work culture. Competitive salary Medical, Dental and Vision Insurance have very low out of pocket costs (for FT staff) Medical can be as low as $1 dollar per paycheck / $26 dollars a year for full medical coverage ( for FT staff) Generous Paid Time Off policy (for full time staff) Group Life Insurance and Long Term Disability (for full time staff) Flexible Spending Accounts (for full time staff) Pre-Tax Commuter Benefits 403(b) Retirement with Employer Match Opportunities for career advancement Access to BCBA, CEU's and CTLE credits * We adhere to all strict COVID guidelines at all of our programs and sites. Qualifications are subject to change in accordance with government regulations. QSAC is Equal Opportunity Employer (EOE) Mission-Oriented. Results-Driven. Collaborative. Passionate. We Are QSAC. To Apply: Please send resume to *************