Clinical research coordinator jobs in Valley Stream, NY - 448 jobs

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)

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications 3-5 years Strong Project Management Regulatory submission experience Oncology experience Participate on a cross functional team focused on US regulatory submissions (FDA). * Previous Pfizer experience is preferred; Pharmaceutical/biotech experience mandatory. Familiarity with U.S. NDA processes required Provides Financial Oversight Forecasts and manages high level clinical trial budget. Oversees the study risk planning process (e.g. IQMP) Works proactively with AP/CRO Supports Practical Clinical Trial Design o Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design. o Initiates and ensures a Protocol Operational Feasibility and Budget assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed. o Facilitates early engagement of Alliance Partners/Vendors when needed. Additional Information $70/hr 6 months

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 ************ ****************************

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.

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

Clinical Research Site Manager The Site Manager's job is to 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. Also To ensure study enrollment meets or exceeds Sponsors' expectations and 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. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Responsible for immediate supervision and performance of the assigned site staff under the supervision of the Site Director or Director of Site Operations. 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. It is the responsibility of the Site Manager to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow-up on the action items, at their respective sites. Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s). Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs, and guidance documents. Ensuring data quality, subject retention, and compliance, timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations Coaching, counseling, and disciplining the employees as applicable. To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards. Communicating and effective implementation of strategic goals from senior management to the site team. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly, and quarterly assigned goals are met for 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: Bachelor's degree preferred Advanced degree preferred Experience: At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization. Credentials: Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred. Knowledge and Skills: Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail. Critical Thinking Active Listening Reading Comprehension - Understanding written sentences and paragraphs in work-related documents. Speaking and Writing to communicate effectively as appropriate for the needs of the audience. Ability to multitask, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams. Strong computer skills in relevant software and related clinical systems are required. Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.

Noom is on a mission to help people live better, longer. We're a consumer-led digital health company, connecting people to content, coaching, community, and clinicians, to build lasting habits and live healthier lives. We're a high-growth organization powered by science, technology, and world-class talent. When you join Noom, on any team, you'll see the impact of your work on the world. Our Clinical Research Team Noom's Clinical Research team is at the heart of our evidence-based approach to whole-person health. We design and conduct rigorous studies to evaluate the effectiveness of our programs and interventions, shaping the future of digital health through science. By aligning clinical integrity with strategic goals, our team ensures Noom's offerings are both credible and transformative. About the Role As Noom continues to expand its research efforts, we are seeking a Clinical Research Operations Manager to support the execution of high-quality research across clinical and UX research initiatives. This role partners closely with the Head of Clinical Research to coordinate study operations, manage regulatory processes, and ensure research initiatives are delivered efficiently and compliantly. You will play a key role in enabling study success through strong project management, operational rigor, and cross-functional collaboration. You Will Own operational execution across clinical and UX research studies, including timelines, milestones, and deliverables Triage incoming Jira Research Ask Tickets and maintain the Research Prioritization deck Perform budget reconciliation and planning across clinical research programs Track timelines and deliverables, surfacing and escalating blockers as needed Develop operational processes for new studies, including SOPs and training documentation Full command of study start-up with milestone planning and ongoing troubleshooting Oversee logistics for participant recruitment, tracking, and data management workflows Train and oversee Study Coordinators, ensuring high quality data capture and execution of protocols with minimal protocol deviations Manage Institutional Review Board (IRB) submissions, renewals, and amendments Ensure all research activities align with ethical guidelines, regulatory standards, and Noom policies Organize the team and processes that translate claims needs into scoped research projects Develop study protocols and measurement tools Manage and maintain records for study preregistration Collaborate with statisticians and analysts to interpret data and generate insights Manage and contribute to scientific outputs including manuscripts, white papers, and presentations Support integration of research findings into product and business strategies About You If you're interested in shaping the future of health by operationalizing high-impact clinical research, this role may be for you! You Have A Master's degree required; PhD preferred in a clinical research or health outcomes discipline (e.g., psychology, public health) 3+ years of experience supporting clinical research studies in an operational, coordination, or project management capacity At least 2 years of experience with IRB documentation and compliance Experience using Python and/or R for data analysis Familiarity with multiple electronic data capture systems (EDCs) CCRC or PMP certification preferred Required authorship on peer-reviewed publication(s); first-author manuscripts preferred Experience presenting research at academic conferences Strong project management capabilities, including timeline and resource tracking Ability to manage multiple priorities in a fast-paced, evolving environment Strategic thinking with the ability to align research with broader business objectives Excellent interpersonal and cross-functional collaboration skills What Makes This Job Amazing High-impact role bridging science and strategy at a mission-driven company Opportunities to publish and present original research Collaborative, cross-functional environment with world-class researchers and clinicians Autonomy and ownership over research operations and innovation Compensation Package The US base salary for this full-time position is $120,000. This reflects the salary target for the position for US-based candidates, at the time of posting. The actual salary offer is based on factors including relevant experience and training, assessment of functional skills and behavioral competencies, and location, among others. Other elements of Noom's Compensation Package Noom offers a comprehensive and generous total rewards package. This may include a discretionary performance-based bonus, stock awards, healthcare (featuring a plan with premiums covered by Noom), paid holidays and paid leave (including Summer Fridays), 401k program, and various cash stipends and budgets for employees (wellness, tech, learning & development, etc). Location This position is a hybrid role, with 2 days per week on-site required in one of our offices: New York, NY, USA Princeton, NJ, USA More About Noom Noom is a leading whole-person health platform on a mission to help people live better, longer. We combine personalized medication with the science of behavior change and psychology, to help people build lasting habits and live longer, healthier lives. With nationally-recognized, holistic programs spanning weight, diabetes prevention, GLP-1 support, menopause, longevity, and more, we serve millions through health plans, employers, and direct-to-consumer offerings. As a trailblazer in the world of health and wellness, Noom makes healthy living easy, fun, and deeply rewarding. Join us in shaping the future of health. Whether you're remote or in-office, you'll be part of a passionate, mission-driven team working to make the world a healthier place-one habit at a time. Noom is proud to be an Equal Opportunity Employer, and all applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, caste, national origin, physical or mental disability, protected veteran status, age, or any other characteristic protected by applicable law. Noom is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities. To help protect against potential hiring scams, please be aware that all email communications from the Noom Talent team and/or hiring managers will come only from ************ email address. Please ignore any messaging or communication from other domains (e.g. @noom.team). Noom will never ask you for personal payment, require you to purchase equipment, conduct an interview process or messaging exchange via Microsoft Teams, or extend a job offer without the completion of a multi-step interview process featuring a combination of phone, Zoom, and in-person interviews, as well as references. If you are unsure about the validity of a Noom job posting on another website, we strongly encourage you to apply directly through our website.

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

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. * 5+ 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.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This field-based position is based in either New York or New Jersey. Purpose and Scope: A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: * Site Selection * Pre-trial assessment * Site level Study Participant recruitment/retention plans * Site Activation/Initiation * On-site and remote monitoring * Overall site relationship management in collaboration with other sponsor roles that interact with the site * Close-out activities Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Responsibilities & Accountabilities: * Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. * Develops meaningful site relationships through consistent collaborative communication and engagement. * May participate in site feasibility and/or pre-trial site assessment visits. * Attends/participates in investigator meetings as needed. * May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. * Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. * Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. * Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. * Ensure ongoing adequacy of site (facilities, staff) for trial conduct. * Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA * Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. * Ensures site non-IMP study supplies are adequate for trial conduct. * Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. * Oversees the appropriate destruction of clinical supplies. * Ensures site staff complete data entry and resolve queries within expected timelines. * Ensures validity and completeness of data collected at trial sites. * Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. * Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. * Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. * Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. * Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. * Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. * Prepares trial sites for close out, conduct final close out visit. * Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. * May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. * May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Manage and support the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. Essential Duties and Responsibilities: Assist to plan, implement, manage and report for regional or global clinical studies. Manage selection process of CROs for regional or global clinical studies. Manage the performance of study vendors (e.g. CROs and central labs) Manage activities for clinical site selection, investigator meetings and study initiation. Oversight of patient recruitment and development of recruitment strategies and plans Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.) Tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans. Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols. Coordinate negotiation of clinical trial contracts between investigational sites and CROs. Manage assigned vendors to ensure timely analysis output delivery in accordance with vendor-specific plan. Support coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites. Implement project specific training program and training materials Support creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes. Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.). As needed and required perform other tasks and functions. Qualifications: Must be able to manage and coordinate with the Clinical Lead and Study Manager to achieve project objectives and able to manage/solve project management performance issues if they arise. Demonstrated ability to support the development and management of various aspects of the end to end study operational plan. Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners and vendors. Thorough understanding of clinical operations involved as related to the planning, conducting, and closing clinical studies. Ability to handle multiple tasks and prioritize. Strong organizational, communication and presentation skills. Team player, flexible, ability to adapt to change. Must be able to travel within the US and outside of US 15-25% monthly and interact with Investigators in-person regarding the protocol and study drug. Education and Experience: Bachelor's Degree in sciences or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience. Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. Program and project management experience preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $110,000 to $135,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs Discretionary Bonus Programs and Long-term Incentive Plan Retirement Savings 401k with company match Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown. Career Development, Progression and Training Flexible Work Arrangement Programs Applications will be accepted until January 19, 2025, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

* Job Type: Support Staff - Non-Union * Regular/Temporary: Regular * End Date if Temporary: * Hours Per Week: 25 * Salary Range: $52,000- $65,000 The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. Position Summary The Hunt Molecular Biophysics Laboratory at Columbia University lab uses structural, thermodynamic, enzymological, and computational methods to understand the molecular mechanisms of complex biochemical processes. Hunt Lab is seeking a part-time scientific Research Coordinator position for a project focused on engineering the amino acid and nucleotide sequences of a human protein for use in genetic therapies. The major job responsibilities are coordinating communication and data interchange between four participating laboratory groups at different institutions, managing a publicly accessible project database, and assisting with related grant-reporting and manuscript-writing activities. This is a part-time role, subject to grant funding. Responsibilities Project Communication & Coordination * Serve as the primary liaison between project participants. * Coordinate biweekly Zoom meetings and follow up on action items. * Maintain consistent communication flow to ensure alignment across all sites. * Oversee and coordinate inter-site sample shipments. * Track sample inventory and ensure proper handling and documentation during transit. * Assist with the preparation and submission of progress reports to the funding agency. Data and Website Management * Coordinate the timely posting of data on the project website. * Ensure proper versioning and data labeling for easy accessibility. * Assist project staff in preparing data for upload to publicly accessible databases. * Make basic content and format updates to the project website. * Organize project resources and data presentations as guided by the team. * Ensure that the website is updated with the latest findings, protocols, and relevant documentation. Final Data Deposition * Oversee the deposition of final results into publicly available databases. * Assist staff with formatting and submission requirements. * Ensure compliance with funder and institutional data-sharing policies. Minimum Qualifications * A bachelor's degree is required in a scientific discipline. * A minimum of three years of experience is needed in a research environment. Preferred Qualifications * Master's or PhD degree strongly desirable. * Rudimentary computer programming skills. * Comfort using a standard computer database system. * Two years of continuous laboratory research experience in a related scientific field. Other Requirements * Basic familiarity with research-level molecular and cellular biology and protein structure studies. * Excellent written, verbal, and interpersonal communication skills. * Ability to maintain high confidentiality and professionalism with a client focus. * Strong multi-tasking, prioritization, and organization skills. * Attention to detail, research, critical thinking, analytical, and problem-solving skills. * Self-starter, a fast learner who can work independently under limited supervision. * Work well in an interactive team environment. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.

A Study Manager is responsible to 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. In addition, ensure study enrollment meets or exceed Sponsors' expectations and 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 certifications on a timely basis. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Adherence and compliance to the assigned protocols at their respective site(s). 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. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s). Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s). 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) Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner. Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner. Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation. Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines. Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial. Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents. Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site. Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly and quarterly assigned goals are met for 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. 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 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 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. 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

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 to 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 Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access to the community, Sponsors, CROs, and study participants and their family members. The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations. How You'll Make An Impact Study Preparation: Ability to understand and follow institutional SOPs Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc. Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff Assist with planning and creation of appropriate recruitment and marketing materials Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc. Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives Assist in the creation or review of protocol specific source documents Determine facility, equipment and outsource vendor requirements and availability Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks Study Management: Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety. Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records Collect and evaluate concomitant medications Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual. Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access team in an ongoing fashion Maintain effective relationships with study participants and other Care Access personnel Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management Strong and clear communication skills, both verbally and in writing Accept accountability for actions and function independently Patient Coordination: Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment Obtain informed consent per Care Access SOP and document process when revised ICF discussed with patient during course of the trial Administer delegated study questionnaires, where appropriate. Collect and evaluate medical records with the support of medically qualified members of the study team. Complete visit procedures and ensure proper specimen collection, processing and shipment 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 Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs) Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance. Monitor patient progress on study medication Documentation: Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion. Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart Accurately transcribe data to CRF or EDC. Resolve data management queries and correct source data as needed Record protocol exemptions and deviations as appropriate with sponsor. Complete Note(s)-to-File for patient chart and regulatory filing if necessary Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing Maintain copies of patient-specific correspondence in source charts Assist regulatory personnel with completion of continuing/final review reports Perform other duties as assigned. The Expertise Required Excellent working knowledge of clinical trials, medicine and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+ 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. Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc. 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: BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred RN or LPN preferred Research Professional Certification- CRCC or exam eligibility preferred A minimum of 3 to 4 years Clinical Research experience A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred. How We Work Together Travel: Extensive travel required. Candidates must be willing to travel 75% of the time nationwide. Duties may require travel for a two-week stretch, followed by one week home. Frequency and length of travel may depend on the length and location of study. The expected salary range for this role is $70,000 - $100,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) 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: ********************************

Idea Evolver is seeking a forward-thinking AI-Search Coordinator to join our growing team. This is not your typical SEO role-we're looking for someone who understands people and integrates AI into their everyday workflow. As part of our team, you'll explore how audiences discover information across both traditional and emerging AI-driven platforms, translating those insights into strategies that drive content performance and client growth. You'll collaborate closely with leaders in healthcare and other regulated industries to help them adapt to the future of AI-driven digital discovery.What You'll Do Conduct advanced search behavior research using our AI-powered platform, SEMrush, Google Search Console, and other leading tools. Leverage AI to streamline research, surface patterns, and deliver actionable insights faster. Transform search and performance data into clear, compelling stories and recommendations for clients. Support technical SEO best practices to ensure websites meet modern performance, accessibility, and indexability standards. Monitor and interpret performance metrics (via Google Analytics and other platforms), delivering optimization strategies that move the needle. Stay at the forefront of AI-driven search and conversational experiences, helping clients position their content for visibility in these new discovery environments. Deliver client-ready materials-reports, roadmaps, presentations-that drive meaningful business outcomes. What We're Looking For A human who loves what they do and is energized by solving complex problems. A human who wants to contribute to building AI solutions for search and content discovery. 4+ years of experience in SEO, search analytics, or related digital marketing roles. Outstanding communication skills-able to turn complex insights into engaging, client-friendly narratives. Proven ability to collaborate across disciplines in fast-moving, data-driven environments. Experience in healthcare, life sciences, or other regulated industries is a plus. Why Join Idea Evolver Collaborate with a forward-thinking agency at the forefront of AI and search innovation. Partner with high-profile clients in healthcare and consumer industries. Be part of a collaborative, growth-oriented culture where your ideas directly influence outcomes. Enjoy competitive compensation, comprehensive benefits, and opportunities for professional development. Ready to help shape the future of AI-powered search? Apply today to join Idea Evolver's AI-Search & Analytics team and lead the charge into the next era of digital discovery.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity. Job Description • The Clinical and Research Collaboration (CRC) Liaison has primary responsibility for the oversight and management of clinical and research collaborations within assigned Therapeutic Area(s) • Clinical and research collaborations are research studies/programs and partners with an external collaborator(s) to develop, conduct and execute research that would be used to support the business or regulatory goals • The CRC Liaison will be in support of at least two or more Business Units and/or Research Units that engage with external (third party) collaborators that include but are not limited to principal investigators, research organizations, co-op groups, relevant government agencies (e.g., NIH, NCI), other pharmaceutical companies, drug safety monitoring boards, alliance partners, and any vendors that support CRC activities. • The CRC Liaison ensures the timely due diligence review of CRC proposals, contract generation and execution, and forecasts and coordinates drug shipments across the program globally • This due diligence ensures that proper oversight, risk identification and mitigation are addressed before and during these collaborations with third parties. The CRC Liaison also oversees study progress and collaborates with colleagues to ultimately ensure compliance with CRC processes, systems and regulations • Internally, the CRC Liaison is the primary Point of Contact for colleagues, including TA Medical Teams (within the Business Units and Research Units), RMRSs, PCOs, and Regions, PGRD, Worldwide PharmSci, Contracts & Outsourcing, Safety & Risk Management, Outcomes Research, Project Management, Legal, Regulatory, and Finance. • The CRC Liaison also monitors the CRC-related systems and educational needs of internal and external stakeholders to maintain compliance with CRC policies and guidelines as well as external healthcare law throughout the process • The CRC Liaison will champion operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve CRC functions globally across an asset program. • Manages CRC requests from development to close • Partners with the Project Lead and Legal to work with external collaborator(s) to develop research collaboration proposals • Supervises initial review for completeness and classification of CRC proposals, entry of information into the CRC system, and requests for additional information or documentation through the entire lifecycle of assigned CRC studies. • Liaises with the Project Lead and Legal and external collaborator(s) of CRC proposals, especially those that will require or more sophisticated handling for review and decision. (e.g., proposals from co-operative groups or partnerships) Leads CRC Due Diligence Internally • Informs CRC Functional Line Subject Matter Experts about the proposal and manages their due diligence activities on the CRC proposal • Manages and facilitates Kick-Off and review meetings of Functional Line SMEs, Project Lead and Legal that review and make decisions about CRC proposals • Ensures appropriate and efficient follow-up of Due Diligence including action items and decisions, developing Task Ownership Matrices and Oversight Plans between external collaborator(s) • Collaborates with internal and external partners and stakeholders • Responds to queries from RU/BU ELTs about the status of assigned CRC proposals, studies, and CRC policies and procedures and other internal and external stakeholders, as required • Interacts directly with Collaborator(s), research sites, co-operative groups and public or private sector intergroup and networks globally to facilitate process and execution of CRC studies within assigned TA and to ensure compliance with CRC policy, global and local healthcare laws. • Partners with the Project Leads to manage relationships with PCO and Regional colleagues as required for management of CRC proposals globally as needed • Works with Reporting and Analytics Lead to provide detailed summaries and reports for asset or TA leadership and informs decisions on the management of CRC programs Mediates in the generation of CRC contracts • Facilitates and monitors the efficient and accurate creation of contracts and amendments for CRC studies - new or ongoing - with Legal. • Liaises with the Project Lead and Legal and external collaborator(s) of CRC proposals, especially those that will require or more sophisticated handling for review and decision and due diligence activities for amendments (e.g., proposals from co-operative groups or partnerships) Secures and manages clinical supplies and vendors • Forecasts study drug supply requirements, and initiates requests for clinical supply. • Works with PharmSci colleagues to maintain adequate drug supplies, including pooled supplies when feasible and appropriate • Manages study drug supply inventories, and ensures timely deliveries to sites • Monitors study milestones and requests for additional supply and funding Qualifications • Experience in infectious diseases or vaccines Clinical study experience • No Overtime/Some travel (4-5 times per year) • Minimum of a BS/BA is required with preference for a focus in science or biomedical discipline. (Candidates with equivalent experience as defined below may be considered) • Master's degree, Advanced education and/or training/experience preferred. • Prior Experience in clinical study management or research collaborations is required • Demonstrated effectiveness in working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change. • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization. • Strong knowledge of Therapeutic Area(s), subject matter expertise and international experience are desirable. Additional Information Technical Knowledge- • Strong working knowledge of the scientific and operational issues relevant CRC to study design, drug product(s), disease characteristics, and relevant scientific and operational aspects of drug development. • Solid understanding of GCP, HCL, Regulatory, Safety, and laws applicable to CRC studies • Comprehensive knowledge of appropriate SOPs, processes and systems • Good understanding of other functional areas (e.g., Clinical Supply, Finance, C&O) and organizations (e.g., RMRS and Regions including U.S.) • Experience with financial and CRC drug supply forecasting • Adept at the use of computer based tools and systems (e.g., tracking, financial, document management, etc.) used to support CRC study management (i.e. CRC system) • Excellent written and oral communication skills • Excellent project management skills; capable of managing two or more CRC asset programs at the same time • Provides end-to-end management of CRC processes for multiple asset programs from review to implementation and close. • Brings results to the appropriate attention of Medical to demonstrate ROI. • May serve as an SME for a specific activity related to continuous improvement (e.g., SOP or process).

Jain Global is an innovative multi-strategy / multi-manager investment firm founded on the basis of achieving scale on Day 1, across regions, markets and investors. With over 300 employees operating from offices in New York, Houston, London, Singapore, and Hong Kong, we are looking to add to our growing teams. Overview Jain Global is seeking a highly motivated research coordinator to work closely with the executive assistant team, the head of broker relations and corporate access, and portfolio managers to provide administrative, organizational and strategic support. A high standard of experience, excellence, professionalism, flexibility, teamwork, strong organizational skills, polished communication and the ability to work efficiently under pressure are critical to this role. Responsibilities: Provide day-to-day support for PM and analyst teams including calendar management, travel, expenses and any ad hoc requests Maintain critical reporting systems for Broker Relations team with daily data entry and maintenance Strategically coordinate Research and Corporate Access with external partners Liaise with internal and external partners on behalf of your team including Sell-side contacts, Research Vendors, Corporate IR teams & Expert Networks Work with Compliance team to ensure adherence to policy Collaborate with Research Coordinator team on cross-sector work and provide back-up coverage as needed Contribute to ad hoc projects as the business scales Coordinate domestic and international travel Expense reporting and processing Qualifications: Minimum 3-5 years administrative experience within financial services Bachelor's degree required Strong time management skills Must be teamwork oriented with ability to work independently Excellent organization skills and detail oriented Sense of ownership of work; proactive in following up on details, anticipating needs or issues and closing the loop on requests Mature and strong inter-personal skills; able to interact professionally with peers and senior level management both internally and externally Proficient in Microsoft Office; familiarity with Workday, Bloomberg and CorpAxe is not required but a plus Location: New York We are an Equal Opportunity Employer As an employer, we believe every individual brings with them unique diversity of thought and perspectives to meaningfully enrich perspectives of Jain Global teams to drive competitive performance. We believe an inclusive environment can yield exceptional contributions. #LI-DNI

A top NYC Hedge fund is seeking to hire a Junior Research Coordinator to work closely with the Research Coordinators providing administrative and operational support to the Investment Research team. The ideal candidate is an intrinsically motivated team player who sets high expectations for him/herself and has a positive mindset and passion for organization. RESPONSIBILITIES: Coordinate calendars and logistics for calls, meetings, and HQ visits with public company management teams Manage Outlook calendars for earnings call invites by monitoring and updating earnings call details across distribution lists Act as vendor relationship manager for all existing and new research subscriptions, contracts, and association memberships Schedule, transcribe and organize department wide internal meetings, not limited to taking detailed notes, compiling meeting materials/agendas, troubleshooting technical issues, and distributing daily reminders of upcoming calls, meetings, and investor events Coordinate strategy marketing binders quarterly and manage the deliverables spreadsheet for Investment Research, Trading, and Client Development teams Responsible for coding and monitoring entries to the department's central analyst calendar New Hire Onboarding: compile and distribute onboarding resources (welcome packets); maintain and update Research Handbook; add new hires to weekly calls/meetings and liaise with IT to add to email distribution lists Training Library: training and teach-in library support (schedule related events, distribute materials, and archive presentations in the research management platform; request legal and compliance approval and work with IT to record trainings for reference) Coordinate department wide engagement activities and/or off-site events, as needed Act as coverage support for administrative professionals across the department QUALIFICATIONS: Bachelor's degree A minimum of 1-2 years of related experience High level of accuracy, attention to detail and follow through Demonstrated organizing, planning, and problem-solving abilities Positive attitude and approach to assignments, regardless of how big or small Excellent interpersonal, writing, and communication skills Proficient in Microsoft Office Highest degree of integrity, professionalism, and confidentiality

The Clinical Research Coordinator plays a pivotal role in the execution of clinical trials by utilizing Good Clinical Practices (GCP) to screen, enroll, and monitor study subjects while ensuring compliance with protocols and regulations. Responsibilities * Prioritize activities according to protocol timelines. * Maintain adherence to FDA regulations and ICH guidelines throughout the clinical trial process. * Foster effective relationships with study participants and research personnel. * Interact professionally with patients, sponsor representatives, investigators, and management. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits. * Identify and report adverse events and serious adverse events promptly. * Prescreen study candidates and obtain informed consent. * Conduct visit procedures in alignment with protocol guidelines. * Train others and perform basic clinical procedures such as blood draws and ECGs. * Review laboratory results and test outcomes for completeness and alert values. * Discuss study medication and required procedures with the Investigator and site staff. * Record data legibly and enter it in real-time on paper or electronic sources. * Manage study medication inventory and patient compliance accurately. * Resolve data management queries within sponsor-provided timelines. * Assist with regulatory documentation and source document creation. * Contribute to recruitment planning and material development. * Work with recruitment teams to actively recruit subjects. * Review and assess protocol amendments for clarity and feasibility. * Ensure training and study requirements are met before trial conduct. * Attend Investigator meetings as required. * Ensure adequate supply availability for protocol initiation. Essential Skills * Strong understanding of institutional SOPs. * Excellent knowledge of medical and research terminology. * Familiarity with federal regulations and good clinical practices (GCP). * Effective communication and teamwork skills. * Strong organizational and leadership capabilities. * Attention to detail. * Proficiency with clinical trial databases, IVR systems, and EDC. * Critical thinking and problem-solving abilities. * Positive attitude and high level of motivation. * Professional writing and communication skills. * Ability to work independently in a fast-paced environment. Additional Skills & Qualifications * Bachelor's Degree preferred or equivalent combination of education and experience. * Minimum of 3 years of prior Clinical Research Coordinator experience required. * Recent phlebotomy experience required. Work Environment The position is based in an on-site clinic environment, providing opportunities to engage directly with patients and research personnel in a dynamic setting. Job Type & Location This is a Permanent position based out of Hoboken, NJ. Pay and Benefits The pay range for this position is $75000.00 - $80000.00/yr. 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 Workplace Type This is a fully onsite position in Hoboken,NJ. Application Deadline This position is anticipated to close on Jan 14, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.