Clinical research coordinator jobs in North Hempstead, NY

Regional Cancer Care Associates (RCCA) is looking for an exceptional Clinical Research Manager to join the team. This position manages clinical research program and operations in accordance with USON SOP and ICH GCP guidelines. Coaches and develops staff. Develops research accountability standards, metrics, and reports and identifies areas for improvement Implements action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. ICH GCP guidelines. Coaches and develops staff. Develops research accountability standards, metrics, and reports and identifies areas for improvement Implements action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures(SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. Supports and adheres to the US Oncology Compliance Program, to include Code of Ethics and Business Standards. This individual must also possess strong multi-tasking abilities and bring positivity and passion to their work. If you want to join a team that is on the cutting edge of cancer care, while always putting the patient first, we want to hear from you! Employment Type: Full Time Location: Belleville, NJ As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities. We believe these benefits underscore our commitment to the well-being and professional growth of our employees. Key Responsibilities: Manages clinical research program and operations in accordance with USOR SOP and ICH GCP guidelines. Responsible for ensuring at the administrative level that all research activities are coordinated with affected departments within the practice. Coaches and develops staff. Responsible for recruitment, interviewing, recommending hires, assessing performance, recommending salary changes, and progressive discipline. Enforces adherence to company policies. Develops research accountability standards, metrics, and reports and identifies areas for improvement. Implement action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. Develops accountability standard to ensure that targets and budgets are achieved. Collaborates with the SRL, physicians of the practice, research committee, and other research management in the process of study selection for the research program. Responsible to promote or market research program to the practice, community and referring physicians. Responsible for coordinating research activities with other (non-USOR) bases or sponsors. Requirements Minimum Job Qualifications (Knowledge, Skills, & Abilities): Education/Training: Bachelors degree in a clinical or scientific related discipline desired, Bachelors degree in nursing preferred. Business Experience: Minimum of 7 years clinical nursing experience or scientific related discipline required, preferably in oncology Minimum of 2 years of supervisory experience preferred, experience in clinical research preferred If required for state of practice, current licensure as a registered nurse (RN) SoCRA or ARCP certification preferred Specialized Knowledge/Skills: Excellent communication skills, strong ability to multitask Strong interpersonal skills Must be able to work in a fast paced constantly changing environment Knowledge and proficiency in all basic computer programs, windows, excel etc. Special knowledge of GCP and ICH guidelines Specific knowledge of all aspects of clinical research - ability to read, analyze and interpret technical items such as protocols, informed consent documents, and regulatory documents, ability to solve problems and implement solutions Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trails Basic knowledge of financial management to include budgeting and contracting, understanding of site financials including revenue cycle Working Conditions: Traditional office environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements (Lifting, standing, etc.) - Large percent of time performing computer based work is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)

Title: Coordinator, Fabric R&D of Denim & Woven Bottoms Reports To: Manager, Fabric R&D About American Eagle American Eagle is a youth culture brand grounded in denim. Our purpose extends beyond making the best jeans-we embrace self expression, culture, optimism and connection. Through the brand platform Live Your Life, we empower our community to be who they want to be all while wearing the clothes that make them most confident. Get to Know the Role: Coordinate raw material sourcing and development for our AE denim and woven bottoms fabric categories. Source and develop category-appropriate fabrics that meet the timeline, quality, fit for purpose, price point, and aesthetic guidelines established by CFT partners for each category. What You'll Do: Source and develop trend-right, brand-appropriate materials Help to acquire seasonal collections from the supply base or set up appointments to review collections when possible. Identify items that meet seasonal needs and present to design team for selection Oversee the development of materials that are designed in-house by the AE design teams Acquire testing documents from suppliers to ensure materials meet industry and AEO standards Research trends in raw material design and innovation. Maintain daily communication with the supply base. Adhere to seasonal development calendar with internal and external partners; elevate issues to manager as needed Work to ensure milestone deadlines are met and that needed information is obtained from CFT partners on time Pre-position key materials to ensure on-time sample execution; arrange substitute materials as necessary Ensure that suppliers submit materials for approval on time and comply with all development deadlines Promote efficiency and effective problem solving with suppliers and internal teams to meet development and production deadlines Actively participate in key milestone meetings with design, production and merchants Support financial goals for each category Partner with PD and production teams to ensure that new development meet the pricing and MOQ/MCQ needs of each category Provide cost-engineering options for items that do not meet IMU targets Re-source materials as needed to meet financial targets Maintain material library and internal records database Obtain Material Profile Sheets for all items sampled and organize all records on internal shared drive. Ensure information on profile sheets is updated as needed Update and maintain development chart through handoff to Production Teams Create PLM codes for sampled materials in Tradestone Ensure that the material library is up-to-date and organized. Other projects and responsibilities as assigned What You Bring: Bachelors' Degree in Fashion or Textiles; 2-4 years of related experience Denim experience a plus High degree of proficiency MS Office Suite, Outlook & Internet applications Strong analytical, interpersonal, problem-solving, presentation, and project management skills Strong verbal and written communication skills Demonstrated collaborative skills and ability to work well within a team Ability to work with and influence peers in a fast-paced, deadline-oriented environment Self-motivated with critical attention to detail, deadlines and reporting Comfortable working in an hybrid environment - working in office a few days a week (based on the needs of the business or big milestone week) with occasional remote work from home Perks: Why You'll Love it Here Generous employee discount Summer Fridays Casual dress code Hybrid schedule FOMO events (Exciting company-wide events) Gym Discounts Competitive Company Bonus Internal Mobility & Growth Pay/Benefits Information: Actual starting pay is determined by various factors, including but not limited to relevant experience and location. Subject to eligibility requirements, associates may receive health care benefits (including medical, vision, and dental); wellness benefits; 401(k) retirement benefits; life and disability insurance; employee stock purchase program; paid time off; paid sick leave; and parental leave and benefits. Paid Time Off, paid sick leave, and holiday pay vary by job level and type, job location, employment classification (part-time or full-time / exempt or non-exempt), and years of service. For additional information, please click here. AEO may also provide discretionary bonuses and other incentives at its discretion.

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)

Country Lead Monitor ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to drive the successful delivery of clinical trial outcomes. What you will be doing * Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards. * Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures. * Build and manage strong relationships with trial investigators and stakeholders. * Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines. * Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management. Your Profile * University degree in medicine, science, or equivalent combination of education & experience * Demonstrated ability to drive the clinical deliverables of a study * Subject matter expertise in the designated therapeutic area * Prior monitoring experience is preferred * Ability to travel up to 20% What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Salary range: $110,520.00-$138,150.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here to apply

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.

Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications. At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources. Job Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, Client, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications BS/MS Additional Information For more information, Please contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

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

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

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Title: Clinical Research Scientist Duration: 12 Months (Possibility of Extension) Location Woodcliff lake NJ Job Responsibilities: The incumbent is responsible for, but not limited to the following: Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) Performs literature search and data analysis to address research questions In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) Assisting in database cleaning, review of study results, and interpretation of results Adhering to key performance indicators for clinical study development, conduct, and reporting Individual contributor with specialized knowledge Presents concepts, facts, and reports and advises on key trends and issues Troubleshooting routine site inquiries Work is completed under limited supervision Supports the planning, execution and reporting of clinical programs/trials May handle multiple protocols simultaneously Contributes to risk resolution by escalating and monitoring project risks Qualifications Qualifications Minimum of 2-5 years of experience in clinical research in the pharmaceutical industry A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; Bachelor's Required. Doctoral (PharmD or PhD) or MD degree preferred . Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus Thank you for your time and consideration. I look forward to hearing from you! Kind Regards Ruchi Kumari Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO Certified MBE | GSA - Schedule 66 I GSA - Schedule 621I (DIRECT BOARD) # 732-844-8716 (F) 732-549-5549 LinkedIn: https://www.linkedin.com/in/ruchi-kumari Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

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.

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.

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.

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.

Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits. I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization. Job Description Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/ CTD/ MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry Additional Information All your information will be kept confidential according to EEO guidelines.

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

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: ********************************