Clinical research associate jobs in Babylon, NY

6 month contract w/ renewal 3 days onsite in Jersey City, NJ We are seeking a Clinical Scientist Data Reviewer that will support the scientific planning efforts and collaborate with Clinical Research, Pharmacovigilance and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate technical skills and scientific acumen as part of a cross-functional clinical development team. You will be a key contributor and supporter in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians, including protocol development, study implementation, data analysis and reporting of results. This role will be focused on the detailed and critical safety data review efforts from study start-up through final CSR. The Clinical Scientist Data Reviewer is a crucial role in analyzing and interpreting clinical trial data to ensure accuracy, integrity, and compliance with regulatory requirements. There is additional room for growth and leadership opportunities in this role. Responsible for supporting specific aspects of clinical/scientific execution of clinical protocol(s). This may include: Serving as a supportive clinical scientist data reviewer focused on safety, efficacy and critical data deliveries as part of the clinical trial team Supporting the clinical study team as part of the clinical sciences functional line which is closely aligned with the medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance (as well as other functional areas in this matrix environment) Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); partnering with Clinical Operations on critical and key study deliverables Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming Collaborating cross-functionally to review clinical data to ensure quality, completeness, and integrity of trial conduct Potential to provide tactical/scientific mentorship to other clinical scientists and move into Clinical Scientist lead role as well as focus on scientific growth and development Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate) Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs Qualifications 6+ years of experience with a Post Graduate Degree or 8+ years of experience with a Bachelor's degree in a relevant scientific discipline. Experience in clinical drug development experience, or a PhD, Pharm D, or RN degree is preferred. Experience within oncology preferred Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH) Ability to manage multiple competing priorities with good planning, time management and prioritization skills Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports Interact with key stakeholders across Clinical Development functional areas Role requires proactive approach, strategic thinking and leadership in driving toward clinical study goals Influence opinions and decisions of internal and external customers / vendors, across functional areas Problem solving, prioritization, conflict resolution and critical thinking skills Strong communication, technical writing, and presentation skills experience

Atlantic Group is seeking a detail-oriented and proactive Administrative Researcher to support our Accounting & Finance recruiting team. This role is ideal for someone who enjoys research, organization, and playing a behind-the-scenes role in driving team productivity and accuracy. You'll work closely with recruiters and leadership to manage data integrity, conduct market and candidate research, and assist in daily administrative tasks that help streamline the recruiting process. Responsibilities: Conduct research on potential candidates across LinkedIn, internal databases, and industry-specific platforms. Maintain and update candidate and client records in Bullhorn (our CRM system) to ensure data accuracy. Support recruiters by building and maintaining targeted candidate lists for ongoing searches. Assist with tracking candidate pipelines, interview schedules, and submission logs. Prepare weekly activity reports and dashboards for the team. Provide ad hoc administrative support, including calendar coordination, database updates, and report generation. Conduct basic market mapping and research to identify new business prospects and hiring trends. Collaborate with the recruiting team to identify process improvements and increase workflow efficiency. Qualifications: Bachelor's degree required. Strong attention to detail and organizational skills. Excellent written and verbal communication. Proficient with Microsoft Excel, Google Workspace, and LinkedIn. Interest in recruiting, finance, or business operations. Positive attitude, curiosity to learn, and a team-oriented mindset.

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

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 providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K

Cellectis' Clinical Sciences (CS) organization is seeking a highly motivated and experienced clinical Research Scientist to support the both the development and execution of our innovative proprietary UCART allogeneic CART cell therapies programs. The Director, Clinical Research Scientist participates in design and implementation of the development strategy and supports the Clinical Science Physicians with various deliverables necessary for effective and efficient planning and execution of their assigned program. Additionally, the successful candidate in this role would also be responsible for working closely with the Clinical Operations Team to support the development of clinical development processes, templates and potentially training and management of junior clinical research scientists. Job Responsibilities Supports the clinical development of assigned programs and participates and supports the design and implementation of the development strategy Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA) The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience May co-lead study team meetings in partnership with Clinical Operations study lead Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums, act as primary point-of-contact for clinical study or program for clinical science related activities, and providing clinical science inputs into study safety reporting. Clinical Scientists are likely to have regular external interactions with a variety of internal and external partners and stakeholders, such as cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups. They may also, alongside the Clinical Sciences Physician, participate in external interactions with health authorities (HAs) Provides strategic clinical science support for assigned studies and programs Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required May author and/or review clinical narratives in conjunction with pharmacovigilance in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion in concert with Clinical Science Physicians In concert with Clinical Sciences Physicians provide clinical contributions to internal documents and presentations including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts) As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists Where applicable, may manage one or more direct reports and is, in such instances responsible for hiring, training, developing, and retaining talent on his/her staff. As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment Core Competencies Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally Outstanding written communication skills Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points Comfortable working in fast paced entrepreneurial environment Ability to travel up to 20% Education and Experience Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred) Minimum of 5 years pharma/biotech industry experience in clinical development in oncology/hematology clinical trials experience in CAR T-cell therapy is preferred Experience in data review, data cleaning, managing and interpreting clinical trials results as well as exposure to writing protocols Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research Physical Requirements In office 4 days per week, required Sedentary, desk position Salary Range $175,000-225,000 (final salary is dependent on candidate's experience and credentials)

Collabera is ranked amongst the top 10 Information Technology (IT) staffing firms in the U.S., with more than $525 million in sales revenue and a global presence that represents approximately 12,000+ professionals across North America (U.S., Canada), Asia Pacific (India, Philippines, Singapore, Malaysia), and Europe (Ireland, Netherlands, Poland, United Kingdom). We support our clients with a strong recruitment model and a sincere commitment to their success, which is why more than 75% of our clients rank us amongst their top three staffing suppliers. Not only are we committed to meeting and exceeding our customer's needs, but also are committed to our employees' satisfaction as well. We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera. As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as the “Best Staffing Firm to Work For” for five consecutive years since 2012. Collabera has over 50 offices across the globe with a presence in ten countries and provides staff augmentation, managed services and direct placement services to global 2000 corporations. For consultants and employees, Collabera offers an enriching experience that promotes career growth and lifelong learning. Visit ***************** to learn more about our latest job openings. Awards and Recognitions --Staffing Industry Analysts: Best Staffing Firm to Work For (2016, 2015, 2014, 2013, 2012) --Staffing Industry Analysts: Largest U.S. Staffing Firms (2016, 2015, 2014, 2013) --Staffing Industry Analysts: Largest Minority Owned IT Staffing Firm in the US. Job Details: Job Title: Clinical Research Specialist Location: Manhattan, NYC Duration: 6 months (could go beyond) Job Description: · Job function includes, study coordination and implementation of a new clinical study. · The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies. · The position works closely with the Principal Investigator, members of the department, study sponsors and monitors, and the institution, to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of clinical studies. It is a full time position, Monday-Friday. Positive candidate must possess the following: · Experience as a study coordinator 1-2 years in a hospital or outpatient setting, preferably with imaging trials, and EDC systems. · High organizational ability with strong attention to detail · Flexibility with a team player attitude · Professionalism · Proficient with MS Office, Outlook and Internet Explorer · Critical thinker and problem solver · Please include a cover letter with your resume. Qualifications Education Requirements : 4 yr Bachelor's Degree. Clinical research experience required. Additional Information To know more about this opportunity, please contact: Ujjwal Mane ************ ****************************

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

Aidoc helps health systems deliver smarter and faster care when it matters most. Its mission is to transform patient outcomes through 'always on' clinical AI, eliminating preventable care gaps that lead to loss of lives and disabilities. Through our proprietary ai OS platform, Aidoc seamlessly integrates real-time intelligence into provider workflows, helping physicians make faster clinical decisions for over 45 million patients a year. With the most FDA-cleared AI solutions in its category and deployments across 150+ health systems globally, Aidoc elevates the physician and patient experience. Backed by General Catalyst, Square Peg, NVentures (NVIDIA's venture arm), and four major U.S. health systems, Aidoc has raised $370 million to date, including a recent $150 million round to accelerate development of CARE, its clinical-grade foundation model. About this role This position focuses on shaping and advancing pivotal study design strategy for AI-enabled medical devices.You will be responsible for designing and authoring pivotal study protocols, as well as planning, writing, and executing pivotal study reports that demonstrate clinical value and align with regulatory requirements. This role requires both creative and critical thinking, balancing established, well-tested study methodologies with innovative approaches enabled by large-scale real-world data and Aidoc's solution deployments. You will collaborate closely with product, regulatory, clinical, and AI teams to establish new paradigms for clinical evidence generation in a rapidly evolving field. This position is located in the US (remote) or Israel. Responsibilities * Lead the design of pivotal clinical studies, incorporating both traditional and novel approaches to study design. * Write, edit, and manage pivotal study protocols, statistical analysis plans, and study reports. * Partner with product, regulatory, and AI teams to align study design with product strategy and regulatory requirements. * Develop innovative real-world study designs that leverage large-scale Aidoc implementations. * Perform and interpret statistical analyses to inform study design and study outcomes. * Contribute to the preparation of regulatory submissions, including pivotal study documentation. * Stay abreast of evolving clinical research methodologies and regulatory guidance, particularly in AI-enabled medical devices. Requirements * Advanced degree (Masters or PhD) in Biostatistics, Epidemiology, Clinical Sciences, or related field. * 3+ years experience navigating AI study designs and regulatory expectations for AI-driven devices. * Demonstrated expertise in clinical research design and statistical analysis. * Proven ability to write and manage clinical study protocols and study reports. * Strong critical thinking and analytical skills with a track record of creative, outside-the-box study design approaches. * Excellent written and verbal communication skills, with experience in scientific publications or regulatory submissions. Strong drive to innovate and create new paradigms for clinical evidence generation in emerging device categories. Working at Aidoc We're a dynamic, collaborative and fast growing team of more than 400 global employees, committed to improving the world of healthcare. We're looking for mission-driven people excited to do transformative work. We have offices in Tel Aviv and New York City, but Aidoc is a remote-first workplace. We're able to hire US-based employees across the continental United States, although certain roles may be region-specific. What we offer: * A range of medical, dental and vision benefits * Stock options for all full-time employees * 20 days of paid vacation, plus sick days and holidays * A 401(k) plan, life insurance, plus long and short term disability * The opportunity to directly improve medical care and impact patient outcomes Aidoc is deeply committed to creating an inclusive and diverse workplace, and to the principle of equal opportunity for all individuals. We prohibit harassment of any type as well as discrimination based on race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, or any other status protected by law.

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description * Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. * Author abstracts and manuscripts for publication in peer-reviewed journals. * Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. * Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. * Oversee and coordinate the collection of and/or collect pre-study documents * Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. * Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. * Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications * Minimum 2-5 years of pharmaceutical industry clinical trial experience. * Experience in immunology or endocrinology therapeutic areas is a plus. * Primary experience with development of clinical trial protocols. * Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. * Good understanding of FDA regulatory, ICH, and GCP requirements. * Excellent communication skills, written and verbal. * Superior interpersonal communication and the ability to work across company disciplines and functional units. * Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. * Attention to detail and a commitment to high quality and on-time deliverables are key success factors. * Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

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.

About the Job: The Research Coordinator's role is to help the research practice operate more efficiently. They do this by handling the logistics to make research run smoothly so that researchers can focus on what they do best - conduct research. Research Coordinator duties may include project and client management, creating and managing materials for research, participant recruitment and session scheduling, incentive management, tool and data management, etc. What You'll Do: * Coordinate research participant recruitment * o Identify and recruit research participants per researcher specifications * o Coordinate schedules of research participants, researchers, and stakeholders * o Manage incentives * o Manage lists of past and future research participants * Manage software systems used for data collection and analysis * Coordinate with Design Program Managers, Design Leads, and other stakeholders * Work as part of the larger Design Operations team and may be called upon to do operational work for the broader design organization. * If capacity allows, manage projects across the research organization. Including * o Prepare study materials and data collection tools for research sessions * o Schedule planning, research, and report-out sessions for researchers * o Prepare data for analysis * o Create and manage data repositories and handle records retention Skills You Have: * Bachelor's degree, or equivalent * Experience providing operational support to fast-paced research teams. * Experience with research participant recruitment * Demonstrated skills in increasing team efficiency. * Strong communication and organizational skills with attention to the right details to ensure operations run smoothly * An ability to anticipate and proactively solve logistical issues so your team knows they'll never miss a beat when you're coordinating their work Additional Qualifications We'd Love: * 2 years' experience collaborating with live research teams. * Experience working in a highly regulated environment like healthcare or financial services. * Professional association with the Research Ops community. #LI-Hybrid Compensation Range: Pay Range - Start: $60,340.00 Pay Range - End: $112,060.00 Geographic Specific Pay Structure: Structure 110: $66,360.00 USD - $123,240.00 USD Structure 115: $69,370.00 USD - $128,830.00 USD We believe in fairness and transparency. It's why we share the salary range for most of our roles. However, final salaries are based on a number of factors, including the skills and experience of the candidate; the current market; location of the candidate; and other factors uncovered in the hiring process. The standard pay structure is listed but if you're living in California, New York City or other eligible location, geographic specific pay structures, compensation and benefits could be applicable, click here to learn more. Grow your career with a best-in-class company that puts our clients' interests at the center of all we do. Get started now! Northwestern Mutual is an equal opportunity employer who welcomes and encourages diversity in the workforce. We are committed to creating and maintaining an environment in which each employee can contribute creative ideas, seek challenges, assume leadership and continue to focus on meeting and exceeding business and personal objectives.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Patient Coordination * Prescreen study candidates * Obtain informed consent per Care Access Research SOP. * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines. * Assist regulatory personnel with completion and filing of regulatory documents. * Assist in the creation and review of source documents. * Patient Recruitment * Assist with planning and creation of appropriate recruitment materials. * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Other Responsibilities * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct. * Communicate clearly verbally and in writing. * Attend Investigator meetings as required. * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management * Maintain effective relationships with study participants and other care Access Research personnel. The Expertise Required * Ability to understand and follow institutional SOPs. * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 1-year prior Clinical Research Coordinator experience required * Recent phlebotomy experience required How We Work Together * Location: Position requires onsite work 5 days per week at the Yonkers, NY or Hoboken, NJ clinic. * Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives. * Physical demands associated with this position Include: * Walking-20% * Standing-20% * Sitting-20% * Lifting-20% * Up to 25lbs Overhead * Driving-20% The expected salary range for this role is $55,000-$85,000 USD per year. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. Benefits & Perks * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

Job Details New Jersey City - Jersey City, NJ $64000.00 - $80000.00 Salary/year Clinical Research Coordinator I The Clinical Research Coordinator I will work at site to help ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training, as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Submitting required administrative paperwork per company timelines. Participating in subject recruitment and retention efforts. Engaging with Research Participants and understanding their concerns. Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff Any other matters, as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required Bachelor's degree a plus Foreign Medical Graduates preferred Experience: 1+ years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. 2+ years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Proficient communication and comprehension skills both verbal and written in the English language are required. Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

The Clinical Research Coordinator III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training, as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s) Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s). Ability to train and mentor site staff, as needed Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s). Maintaining a working knowledge of Study Participants' Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team. Maintaining a working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s) Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings Any other matters as assigned by management KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required Bachelor's degree preferred Foreign Medical Graduates preferred Experience: Minimum of 5 years experience in Clinical Research Supervisory experience preferred Wide therapeutic range of clinical trials experience preferred Regulatory research experience is a plus Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Goals-driven while continuously maintaining quality. Must be detailed-oriented, proactive, and able to take initiative. Must have strong written and communication skills. Must have excellent customer service skills. Bilingual in Spanish is a plus

St. John's, established in 1870, has two New York City campuses; international locations in Rome, Italy; Limerick, Ireland; and Paris, France; and study abroad locations around the world. The Princeton Review and other top rankings consistently recognize the University's outstanding academics, diverse student body, dynamic internship, and volunteer opportunities, focus on student life, and diverse study abroad offerings. St. John's University offers more than 100 undergraduate and graduate programs in its six colleges and schools, with a growing number of programs offered online. The University is accredited by the Middle States Commission on Higher Education and 12 other major academic and professional associations. A dedication to diversity, equity and inclusion is at the heart of our mission. As a Catholic and Vincentian university, St. John's is committed to institutionalizing practices of inclusive excellence to ensure that we welcome and celebrate the intrinsic worth of all members of our community. We will become an even stronger university as we enhance equity at every level of our institution. Our graduates will excel in the competencies and values needed for leadership and service in a rapidly evolving world. Job Opportunity: Intake Coordinator/Research Assistant for Child Trauma Clinical Research Program Child HELP Partnership (CHP) at St. John's University is seeking a Bachelor's-level applicant for an Intake Coordinator/Research Assistant, beginning immediately. CHP is designed to protect and heal children and caregivers from trauma and its emotional impact. Founded in 2001, CHP is nationally recognized as a leading source for evidence-based mental health treatment and prevention of childhood trauma. The CHP team delivers free therapy in our clinic and online for children and their parents. In addition, CHP offers educational training to parents, other adults caring for children, and mental health professionals. Parents and caregivers are empowered with strategies to prevent trauma. Clinicians across the country are empowered with scientifically-sound therapies that mitigate the impact of trauma. CHP recently received a $3 million grant to train communities in eight states on their evidence-based services and interventions. All programs embed evaluation systems so that they are continually improved. The Intake Coordinator/Research Assistant is critical to the success of these initiatives - handling the following administrative, clinical, and research tasks: Administrative * Oversee outreach to community partners, including presentations on child maltreatment, bereavement, and how CHP's services can effectively address children's needs * Coordinate scheduling of assessments and childcare * Train and oversee students and volunteers on childcare, data management in Qualtrics and SPSS, psychological assessments, and other lab protocols * Maintain supplies for all clinical research projects * Assist with development and fundraising activities * Conduct phone screens with caregivers of traumatized and grieving children Research * Compile applications and amendments for the Institutional Review Board * Aid with data collection and management, including building online data collection via Qualtrics, writing SPSS syntax, and data entry and cleaning * Support with data analysis for grant reports * Manage thorough literature reviews on psychological measures to help supervisors determine appropriate protocol changes * Assist with conference presentations and manuscripts The Intake Coordinator/Research Assistant works closely with CHP leadership and staff in a supportive environment. This is a great opportunity to: * Gain experience in a clinical research setting, essential for those interested in pursuing related graduate programs * Strengthen research skills * Hone and present independent projects at research meetings This position requires a minimum of a two-year commitment due to the time spent on training. The Intake Coordinator's schedule is Monday-Friday, 10am-6pm. Start date is immediately to allow for training by current Intake Coordinator. Required skills/experience: * B.A./B.S. in psychology, social work, or related healthcare field * Experience in another research lab * Experience with children in a professional setting * Experience with SPSS * Bilingual English/Spanish preferred If interested, please email your resume and cover letter Dr. Elissa Brown (******************). In compliance with NYC's Pay Transparency Act, the annual salary for this position is $51,000. St. John's University considers factors such as (but not limited to) scope and responsibilities of the position, candidate's work experience, education/training, key skills, internal peer equity, as well as market and organizational considerations when extending an offer. * Important Note- St. John's is NOT an E-Verify Employer St. John's offers a competitive compensation program which is commensurate with your qualifications, experience, and contingent upon the departmental budget. We also offer an extremely comprehensive benefits program to meet the diverse needs of our workforce. Along with exceptional benefits such as medical, dental, life insurance, long term disability insurance, tuition remission, generous 403(b) employer contribution, employee assistance program, and liberal paid time off policies, faculty and staff can also enjoy St. John's performing arts, libraries, bookstores, dining facilities, campus recreation and sporting events Any offer of employment is subject to receipt by St. John's University of satisfactory references, verification of employment and education. St. John's University is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, or any other characteristic protected by law.

Our Community-Based Research Department, housed in the Bronx is currently hiring a Clinical Research Medical Assistant. supports the conduct of clinical trials and research studies by performing both administrative and clinical tasks under the supervision of investigators, research coordinators, or clinicians. We are seeking an individual with previous medical assistant experience and graduate from a Medical Assistant training program who also possesses a National Certified Phlebotomy Technician credential as blood draws are common in this role. Bilingual English/Spanish is required for this role. Key Duties: Assist in recruiting, screening, and enrolling study participants; obtain informed consent in accordance with regulatory and institutional requirements. Prepare participants for visits, record vital signs, collect medical history, and conduct assigned screenings or point-of-care testing. Perform or assist with phlebotomy, EKGs, specimen collection, and other protocol-specified clinical procedures requiring certified technical skills. Label, process, and handle biological specimens per protocol, ensuring accurate tracking and chain-of-custody documentation. Record and verify study data accurately in source documents and electronic data capture (EDC) systems; maintain case report forms (CRFs). Support adherence to IRB guidelines, Good Clinical Practice (GCP), HIPAA, and study-specific protocols to ensure audit readiness. Schedule participant visits, send reminders, monitor adherence to protocol timelines, and follow up on missed appointments or adverse events. Assist investigators and clinicians during study visits, procedures, and patient exams; ensure smooth coordination of care and study flow. Maintain study supplies, prepare materials for monitoring visits, and coordinate with multidisciplinary teams (clinical, administrative, and sponsor staff). Maintain and organize essential study records, including informed consent forms, regulatory binders, subject logs, and communication records. Serve as a point of contact for participants, addressing questions or concerns, and ensuring ongoing engagement throughout the study. Demonstrate professionalism with participants, staff, and sponsors; ensure accuracy, completeness, and timeliness in all tasks and documentation. Minimum Qualifications: High School Diploma and Medical Assistant Certificate is required Nationally Certified CPT/Phlebotomy Tech through nationally accredited institution. 1-2 years of previously Medical Assistant experience. Familiarity with clinical research is a huge plus. Bilingual Spanish/English required Excellent communication skills. Detailed-oriented with ability to multi-task. Starting Compensation: Minimum: $47,840 per annum; Maximum: $49,920 per annum. Work Environment Type, Location, and Schedule:Onsite, Monday through Friday 8am-5pm or 9am-6pm shift, Bronx, NY. As a full time associate at Urban Health Plan, you'll enjoy: Fully funded Health Insurance for you/ 73.5% funded Health Insurance for your family Dental, Vision, and Prescription Coverage 401(k) Retirement Savings (including 3% annual employer contribution) Comprehensive time off including paid vacation, personal time, sick time, and paid holidays (including your birthday!) Flex Spending Accounts (Health care, Dependent Care, and Commuter Benefits) Entertainment Discount Programs Employee Assistant Program Eligibility to apply for Public Service Loan Forgiveness Program (PSLF) Fitness Discounts and Perks through our medical plan. $50,000 term life Insurance About Urban Health Plan:At Urban Health Plan (UHP) our mission is to continuously improve the health of communities and the quality of life of the people we serve by providing affordable, comprehensive, quality, primary and specialty health care and by assuring the performance and advancement of innovative best practices. At UHP, our commitment to provide patient-centered, holistic, quality health care, is part of a tradition started by our founder, Dr. Richard Izquierdo, more than 50 years ago. That tradition continues today by promoting excellence in everything that we do. UHP is an equal opportunity employer. M/F/D/V. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, gender identity, gender expression, national origin/ancestry, citizenship status, disability, age, marital or family status, and military or veteran status.

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 3+ years of clinical research experience Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven

Unblinded Clinical Research Coordinator II DM Clinical Research is looking for an Unblinded Clinical Research Coordinator II to join our team in New Jersey. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials. Duties & Responsibilities: Compound and dispense prescribed IP. Supervise and maintain records of all medications Ensure compliance with study-specific blinding plans. Provide consultative support regarding the preparation and dosing of drugs. Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction. Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials. Understand and apply all applicable site procedures. Ensure receipt and proper storage of IP and bioretention samples. Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy. Review protocols and provide input on clinical and pharmacy supply needs. Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information. Temperature reporting. Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs. Knowledge & Experience: Education: High School Diploma or equivalent required Foreign Medical Graduate is a plus Pharmacy Technician Certification a plus Experience: Clinical Experience Credentials: LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant) Knowledge and Skills: Computer proficiency, especially Word, Excel, Outlook, and Google Docs. Excellent communication and customer service skills. Outgoing personality Well-organized with attention to detail. Must be able to multitask. Bilingual (Spanish) preferred but not required DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an Unblinded Clinical Research Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials. Duties & Responsibilities: Compound and dispense prescribed IP. Supervise and maintain records of all medications Ensure compliance with study-specific blinding plans. Provide consultative support regarding the preparation and dosing of drugs. Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction. Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials. Understand and apply all applicable site procedures. Ensure receipt and proper storage of IP and bioretention samples. Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy. Review protocols and provide input on clinical and pharmacy supply needs. Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information. Temperature reporting. Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs. Knowledge & Experience: Education: High School Diploma or equivalent required Foreign Medical Graduate is a plus Pharmacy Technician Certification a plus Experience: Clinical Experience Credentials: LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant) Knowledge and Skills: Computer proficiency, especially Word, Excel, Outlook, and Google Docs. Excellent communication and customer service skills. Outgoing personality Well-organized with attention to detail. Must be able to multitask. Bilingual (Spanish) preferred but not required