Clinical research coordinator jobs in Greenwich, CT

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Medical Affairs - Global Oncology Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments. Assist in the management of the Trial Master File (submit documents, reconciliation, QC, etc.). Participate in development of protocol, case report form, CRF guidelines and other study documents. Prepare and/or review regulatory documents (e.g. ICF), contracts, requests for proposal. Ensure the training of CROs/investigators on protocol, regulatory, Client SOPs and data issues. Reviews and approves monitoring reports and ensures tracking of ongoing site issues. Minimum of college degree in a relevant discipline. Bachelor's degree in relevant scientific discipline preferred. CANDIDATES MUST HAVE MIN 3-5 years in-house in pharma company. Not just 3-5 years in CRO or onsite monitoring. We want to see associate in-house large pharma. Also, want to see experience in phase 3 global study trials in multifunctional areas. MUST HAVE experience in reviewing patient data and patient profiles. **Oncology Experience Highly Preferred Qualifications BS Additional Information Best Regards, Akriti Gupta ************** Morristown, NJ 07960

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)

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

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

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

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

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

Job Description 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.

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

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.

Coordinates and monitors research trials; actively oversees the recruitment of study participants. May be required to perform venipuncture on study participants; collects, processes, and ships specimens according to protocol and training requirements. Adheres to good clinical practice, and complies with regulatory and grant agency requirements, and study protocol; maintains study records and collaborates with the institutional review board as necessary. Job Responsibility * Responsible for coordination of a designated study or group of studies. * In research projects, oversees recruitment of subjects, implementation of study procedures, and the collection and processing of data. * Keeps accurate and up-to-date records. * Collects labels, logs, processes, and ships biological specimens for analysis according to protocol and training requirements. * Schedules subjects for protocol-related evaluations; collaborates with physicians, investigators and other healthcare providers; promotes respect for subjects' rights. * Administers, scores and evaluates results of assessments as assigned and as related to study protocol; collects data, confers with PI and forwards results to sponsor (internal or external). * Interfaces with external agencies as necessary; organizes all phases of grant process for submission to funding agencies as necessary. * Ensures availability of drug supplies and/or equipment for studies; maintains drug accountability logs. * Liaisons with agencies and pharmaceutical companies, laboratories, and equipment and supply companies, as needed. * Adheres to good clinical practice, and complies with regulatory and grant agency requirements; follows protocol as developed and keeps investigator or supervisor informed of developments. * Collaborates with PI and the food and drug administration and drug companies on related issues; may be required to perform phlebotomy, electrocardiograms, or monitor vital signs on study participants and report findings to supervisor. * Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action. * Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions. Job Qualification * Bachelor's Degree required, or equivalent combination of education and related experience. * 1-3 years of relevant experience, required. * Familiarity with clinical research processes, including informed consent, participant recruitment, and data collection, preferred * Basic understanding of GCP, IRB regulations, and other relevant ethical and regulatory guidelines, preferred * Ability to travel occasionally to clinics and community centers, preferred * Additional Salary Detail The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).

Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change. The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which is assigned. Responsibilities A day in the life of a Clinical Research Coordinator at Hackensack Meridian Health includes: Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol. In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study. Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator. Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversee subject enrollment to ensure that informed consent is properly obtained and documented. Coordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams as required. Works with the study team to draft/create study specific study orders, billing templates and study calendars as necessary. Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols. Monitors all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies. Registers protocol patients with appropriate statistical centers as required. Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts. Acts as principal investigator's representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnel. Along with clinical research nurses, maintains accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required. Works closely with clinical research finance to ensure study patient's clinical trial related activities are billed appropriately. Schedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit. Maintains contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data. Ensures compliant maintenance of all required records of study activity including case report forms, drug dispensation records, or regulatory forms. Oversees and directs the requisition, collection, labeling, storage, or shipment of specimens. Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. Identifies protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions. Organizes space for study equipment and supplies. Participates in the development of study protocols including guidelines for administration or data collection procedures. Contacts outside health care providers and communicate with subjects to obtain follow-up information. Reviews scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues. Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. Attends research meetings and conferences as required. Participates in staff meetings and in-service education as necessary. Other duties and/or projects as assigned. Adheres to HMH Organizational competencies and standard of behavior. Qualifications Education, Knowledge, Skills and Abilities Required: BA/BS diploma/degree in science or healthcare field. Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research. Strong attention to detail and customer service focus. Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential. Excellent organizational, presentation, documentation and interpersonal skills. Excellent written and verbal communication skills. Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms. Education, Knowledge, Skills and Abilities Preferred: Education on human subject research and GCP. Licenses and Certifications Preferred: SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC). If you feel that the above description speaks directly to your strengths and capabilities, then please apply today! Starting Minimum Rate Starting at $82,513.60 Annually Job Posting Disclosure HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to: Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant work experience. Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.

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

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.

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 Clinical Trial Manager needs Bachelor's degree and minimum 3 years experience in the healthcare or clinical trial industry, or the equivalent combination of education and experience. Clinical Trial Manager requires: Extensive knowledge of clinical development principles, theories and concepts and high degree of comprehension of pharmaceutical industry practices, standards and GCP's. Thorough working knowledge of the clinical trial lifecycle from protocol development and feasibility through study closeout and reporting. Ability to manage complex, multiple studies simultaneously. Some may be of a global nature Clinical Trial Manager duties: Manages/oversees the conduct and execution of assigned clinical trails and associated activities in accordance with Good Clinical Practices (GCP) and relevant standards. Assists with the review and determination of appropriate site and vendor selection and ensures all vendors meet predetermined program milestones. Additional Information $54/hr 12 months

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

Job Description 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: ********************************

Title: Manager Clinical Project Planning-REMOTE Contract: 6 Month (renewable) + Manager, Clinical Project Planning, is responsible for developing and managing clinical study timelines. The role involves collaborating with stakeholders to ensure successful clinical trial execution. Key responsibilities include planning, developing, monitoring, controlling, and updating clinical study schedules using scheduling software (e.g, Microsoft Project, Plainisware, etc.), while applying scheduling standards and best practices. In this role, a typical day might include: ? + + Creates and maintains end-to-end study timelines to support study strategy, operational deliverables and goals. + Create schedule baselines and document changes through formal change control processes. Analyze variance between planned and actual performance. Elevate awareness to relevant stakeholders about issues impacting adherence to the baseline. Propose corrective actions to avoid delays and optimize the schedule. + Facilitate collaboration and influence cross-functional teams without direct authority by fostering open communication, building trust, and aligning stakeholders around timeline goals to ensure successful delivery of milestones. - Perform critical path analysis to drive the optimization of trial execution and assess risks to milestone delivery. + Create and manage timeline visuals to clearly convey milestones, deadlines and dependencies, empowering teams to monitor progress, anticipate challenges and maintain alignment for ontime and successful milestone delivery. + Apply scheduling standards and best practices. - Identify improvements for the templates and scheduling processes. + Perform schedule risk analysis in order to determine if milestone dates are achievable. - Perform "what-if" analysis using scenario planning to support in developing and executing trial strategies. Works independently within defined parameters, executing study plans and escalating critical issues when necessary. Typically rely on senior leadership for strategic direction and complex problem-solving Ref: #568-Clinical System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.