Clinical research associate jobs in White Plains, NY - 183 jobs

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

Clinical Research Associate Duration : 12 +months contract Start Time : 08:00 AM End Time : 05.00 PM Total Hours/week : 40.00 Qualifications: The Clinical Research Associate (CRA) is responsible for planning, negotiating, conducting, monitoring, and reporting on clinical trials. The CRA is responsible for protocol development, site selection and qualification, preparing Informed Consent materials, contracting, training, site monitoring, and study document management. The CRA collaborates with data management and statistics groups to ensure accuracy and integrity of study data. The CRA is responsible for preparing reports of study results for investigators and internal development teams, assisting in preparation of regulatory submissions, and supporting publication activities. The CRA will interface with appropriate internal individuals to manage trials in order to meet business objectives and timelines, provide clinical and technical support to product development activities, support product launches, and/or conduct post-market surveillance and evaluation activities. Responsibilities: Responsible for planning, budgeting, executing, and monitoring clinical evaluations of BD products to support product development. Clinical evaluations may also be for post-market surveillance studies, or claims extensions of existing products. Provide product development teams and other functions with technical and clinical expertise and support. Activities will be performed in accordance with international, federal and/or local regulations (FDA, ISO), Good Clinical Practices (GCPs), and compliance with corporate and local quality policies and procedures. Specific Responsibilities: Develop the study design and protocol(s) Screen, select, and qualify principal investigators and investigational sites Conduct negotiations of clinical site agreements and contracts Ensure the compliance to all human subject protection and privacy regulations, including developing Informed Consent materials Develop time schedules and budgets necessary to manage the clinical evaluations Coordinate and plan availability of supplies and shipment of materials Train clinical evaluation participants in study products and procedures. Monitor sites to assure that the Protocol is understood and followed Collect, review, analyze, and report data generated during clinical evaluations in a timely manner, through interactions with Clinical Database/Statistics Communicate results of data analysis to each clinical center, project teams and applicable functions within BD, and actively support the publication and presentation of results by investigators Support the reporting of performance data to regulatory authorities Assumes responsibility for occasional special departmental projects Anticipate 10% to 25% travel (primarily domestic; international travel a possibility

, you must reside in the same country where the job is located. Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. - Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. - Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. - Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. - Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. - Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. - Collaborate and liaise with study team members for project execution support as appropriate. - If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. - If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications - Bachelor's Degree Degree in scientific discipline or health care preferred. - Requires at least 2 years of year of on-site monitoring experience. - Equivalent combination of education, training and experience may be accepted in lieu of degree. - Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. - i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. - Good therapeutic and protocol knowledge as provided in company training. - Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). - Written and verbal communication skills including good command of English language. - Organizational and problem-solving skills. - Effective time and financial management skills. - Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $57,500.00 - $226,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled

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.

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

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.

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)

Sr. Clinical Research Associate NY/NJ 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 Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. **What You Will Be Doing:** + Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. + Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution. + Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting. + Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct. + Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations. **Your Profile:** + Advanced degree in a relevant field such as life sciences, nursing, or medicine. + Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. + Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills. + Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools. + Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment. + Must be located in the Midwest (areas like Chicago or Detroit/Ann Arbor, MI are ideal) + Oncology monitoring experience required + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license **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. Are you a current ICON Employee? Please click here (****************************************************** to apply

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.

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.

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Clinical Study Manager is responsible for the delivery and execution of global clinical studies under the direction of a Study Delivery Lead. This role is primarily focused on tactical study delivery and reports to a Director or higher-level position. The position requires excellent written and verbal communication, project management skills, and attention to detail. The Clinical Study Manager will have routine interaction with key internal and external stakeholders to communicate project status, resolve issues, and troubleshoot routine inquiries. This position may require the Clinical Study Manager to take on a dual role of both operational strategy and study execution. Job Description Responsibilities Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables. In a CRO outsourcing model, responsibilities also include: * Study Oversight: Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials. May provide support as back-up to the Study Delivery Lead as needed. * Cross-Functional Leadership: Participate and provide expertise as a cross-functional study team member, including vendors, and liaise with other departments. Provide mentorship of more junior Operations team members. * Vendor Management: Lead vendor selection, contracting, and management to maintain study quality and compliance and adherence to scope of work within timelines and budget. Oversee complex vendors (i.e., eCOA). * CRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level. Coordinate and develop materials for CRO KOMs and Investigator meetings. * Compliance and Regulatory: Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). * Timeline and Budget Management: Create and coordinate clinical study timelines and budgets with Global Project Management and R&D Finance to meet critical milestones and manage budgets. Responsible for continual review of study timelines and study budget. * Risk Management: Identify, mitigate, and escalate risks per process throughout the study lifecycle. Ensure risks are appropriately logged in the risk management system. * Study Material Development: Co-develop and manage study materials, including training materials, protocols, CRFs, and study operational plans. Ensure all necessary operational materials are in place. * Data Cleaning: Oversee site and monitor data cleaning metrics including EDC data entry, query resolution timeliness, and protocol deviation review. * Site Management: Oversee site selection, start-up, monitoring, and closeout for the trial. * Study Communication: Triage, resolve or escalate study issues /risk mitigations to the Study Delivery Lead. * Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).). oSupports risk Management initiatives oSupports audit/inspection activities as needed oEnsures trial master file is complete and accurate for assigned stud(ies) * Communication and Reporting: Provide regular updates on study progress to key stakeholders. * Training: Identify training needs for key stakeholders as needed, e.g., study team members, vendors and ensure training is carried out. Develop training materials as necessary. Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree preferred in Life Sciences required Experience Qualifications 3 or more years required and Relevant experience is required with a BSc required and Experience in oversight of global clinical trials (all phases) in all stages of delivery with requisite industry training and experience required and Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferred CRA experience preferred Time spent directly in a medical environment (e.g. as a Study Site Coordinator) preferred Familiarity to a Japan-based organization preferred Travel Requirements Ability to travel up to 10% of the time. In-house office position that may require occasional travel (domestic or global). Additional Information Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$133,600.00 - USD$200,400.00 Download Our Benefits Summary PDF

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

Title: Pre-Trial Specialist II Reports To: Program Director - Pre-Trial Services FLSA: Non-Exempt Status: Full-time Supervisory Responsibility: Not Applicable Purpose of the Role: The Pretrial Specialist II is a critical member of the Pretrial Services team, responsible for providing case management and administrative support to the court's judges, attorneys, and other stakeholders. The Pretrial Specialist II will oversee the daily operations of the Pretrial unit in the absence of the Program Director, ensuring efficient and effective management of cases, while maintaining the highest level of professionalism and discretion. The Senior Pretrial Specialist will serve as a direct support to the Program Director - Pretrial Services. Essential Functions of the Role: Provide guidance and training to junior staff members on pretrial procedures, court rules, and policies. Collaborate with judges, attorneys, law enforcement agencies, and other court staff to ensure effective communication and coordination on pretrial matters. Develop and maintain positive working relationships with court personnel, judges, and other stakeholders. Identify and implement process improvements to enhance efficiency, productivity, and customer service. Participate in special projects and committees as assigned by the Pretrial Program Director. Prepare and maintain accurate and detailed records, reports, and statistics related to pretrial matters. Work collaboratively with the court and other pretrial staff team to facilitate and ensure caseload participants' successful completion of mandated supervision appointments and court appearances during the pendency of their legal case. Review legal and court screening documentation and work with participants to analyze their offending behavior patterns, identifying behavioral changes, need for implementation of supports that may reduce likelihood of any pretrial arrests. Provide on-call support as needed. Ensure the timely flow of community outreach and case management activities to meet program goals and objectives. Provide all services in a manner that is gender-responsive, trauma-informed, and that adheres to the core principles of risk-need-responsivity. Special projects and other duties as assigned. Decision-Making Authority: Decisions regarding Pretrial Services are to be made with guidance and collaboration of the Director to whom the Pretrial staff is assigned. It is expected that the Pretrial Specialist will show an increasing ability to make decisions independently on routine matters as knowledge and experience progresses. Working Relationships: Internal: Pretrial Supervisor, Director of Criminal Justice External: Dept. of Social Services, Mental Health Providers, Primary Care Physicians, Parole Officers, Legal Services, District Attorney's Office, Court Officials, Police Departments, etc. Work Schedule: Monday - Friday, 9am - 5pm with some flexibility around client needs. Physical Environment: Traditional office environment. Must be comfortable attending appointments at various courts, agencies, facilities and client's homes. Physical Demands: Must be able to drive a motor vehicle and carry up to 20 lbs. Mental and Visual Demands: Flow of work and nature of duties involve normal coordination of mind and eyes much of the time. Must be able to interact with persons having mental health issues, periods of instability (i.e. lack of shelter, food, clothing or support), recently released from an institution (i.e. hospital, prison), limited comprehension and/or ability to manage through complex scenarios Qualifications for this Role: Bachelor's degree or equivalent experience. Minimum of four years of experience working in human services with individuals with substance use disorders, co-occurring mental health and substance use disorders and involvement in the criminal justice system. Extensive knowledge of community treatment, support services and resources Knowledge of the criminal justice system, court processes and alternative to detention/incarceration services Valid driver's license required and a driving record that will permit the use of an Agency vehicle to transport clients to appointments or other activities as needed. Bilingual English/Spanish a plus. Job Type: Full-time Benefits: 401(k) matching Health insurance Dental insurance Vision insurance Health reimbursement account Paid time off Referral program Schedule: Monday to Friday Work Location: In-person Salary range: $65,000 - $70,000

Berkeley College, a career-focused institution of higher education, seeks a part-time Clinical On-Site monitor to observe and document the clinical procedures Surgical Technology and Surgical Processing Technician students perform in the clinical environment. This individual will also serve as the liaison between the clinical sites and the College. Primary Duties and Responsibilities Observe and document clinical procedures as performed in the clinical setting. Monitor case specialties of Surgical Technology students. Review clinical performance with each student. Review weekly student self-evaluations and skill assessments and advise as appropriate. Maintain clinical attendance logs. Serve as a liaison between the College and clinical affiliate staff. Meet with the Clinical Coordinator to discuss student performance. Occasional administrative work to be performed at the Woodland Park, NJ, campus upon request of the School Dean and/or Clinical Coordinator. Salary Range: $40-$45/hour Job Location The part-time staff position includes off-site visits to clinical sites as well as on-campus meetings and administrative work as requested by the School Dean and/or Allied Health Surgical Clinical Coordinator. Educational Requirements Be a graduate of an educational program in surgical technology accredited by a nationally recognized programmatic accreditation agency. Possess a credential in the field of surgical technology through a national certification program that is accredited by the National Commission on Certifying Agencies (NCCA). Training and/or Experience Have a minimum of three years of documented experience in the operating room scrub role or as an instructor in surgical technology, or a combination of both, within the past five years. Possession of a current unrestricted driver's license. Possess a current CST certification. Knowledge, Skills & Abilities Knowledgeable in the competencies required for competent Surgical Technologists and Surgical Processing Technicians. Knowledgeable about the program's evaluation of student learning and performance. Skilled in Microsoft Office applications such as Word and Excel. Knowledge of learning management systems is preferred. Miscellaneous Mileage, tolls, and parking will be paid to the part-time Clinical Site Monitor and will be based on the College's reimbursement policy. The maximum number of hours worked each week shall not exceed 20, unless prior approval is received. Berkeley College is an Equal Opportunity Employer and considers applicants for all positions regardless of race, color, religion, creed, gender, age, national origin, marital and veteran status, disability, sexual orientation, gender identity or expression, or any other legally protected status. We believe in fostering tolerance, acceptance, and understanding in our community, by employing individuals who bring unique perspectives to the College.

Consumer BrandsResearch & DevelopmentUnited States, Stamford, CT, CTFull TimeRegular **_About_** **_this_** **_position_** At Henkel, you'll be part of an organization that's shaping the future through innovation, sustainability and collaboration. With our trusted brands like Persil , 'all , Loctite , Snuggle , and Schwarzkopf and our cutting-edge technologies, you'll have countless opportunities to explore new paths and grow. This position is with our Consumer Brands business unit - where we empower our employees to bring the best Laundry & Home Care and Hair products to people around the world. _Henkel's R&D labs are planned to relocate to Trumbull, CT in the latter half of 2027. This position will move with the team. Candidates pursuing this opportunity will be working on-site at our Trumbull R&D center once the relocation is complete._ **Dare to learn new skills, advance in your career and make an impact at Henkel. ** **What you´ll do** Business Context + Henkel CTI team (Consumer Technology & Insights) is looking for its new Clinical Study Coordinator to execute clinical studies for claims support and development of new products. If you are interested in supporting R&D needs with strong clinical data and outstanding innovations, then join our CTI community and be a key contributor at Henkel HCB! Main Purpose of the Job + Steer and coordinate clinical studies to strengthen claims support for the HCB NA R&D Team. Duties and Tasks + With the support of the Clinicals manager: + Executes well designed clinical studies per written protocols. + Interprets study results and recommends next steps, as necessary. + Provides topline results and final reports to study sponsors. + Ensures accurate data is generated during the conduct of the study. + Ensures test instruments are properly maintained and calibrated per standard operating procedures. + Highly customer oriented, interact daily with clinical study subjects. Conduct 1 on 1 interviews, collect medical history information, take vitals and apply beauty care products. **What makes you a good fit** Skills + Knowledge of Good Clinical Practices (GCP), Clinical Coordinator certification preferred + Consistently produces dependable and highly reliable results independently, thorough understanding of clinical test methods and interpretation of results + Ability to work in fluid environment, positive interactions with study subjects, that demands creativity with new product test methods + Good communication skills with product development, clinical subjects, etc, and desire to work in a team environment + Assists in clinical study subject recruitment and maintenance of recruiting database Minimum Qualifications: + Education - Minimum of a B.S. degree and experience in study design and the conduct of clinical trials is preferred. + Experience - 1-3 years of relevant laboratory and industry experience + Skills - Consumer product R&D experience preferred, problem solving skills, communication and analytical skills, quick learner, strong interpersonal skills + Certifications and licenses -Certified Clinical Coordinator would be a plus but not required + Physical Requirements: The physical requirements of this job are consistent with an office job: significant amount of time at a computer station. On rare occasions there is a need to lift up to 20 pounds. **Some benefits of joining Henkel** + **Health Insurance:** affordable plans for medical, dental, vision and wellbeing starting on day 1 + **Work-Life Balance:** Paid time off including sick, vacation, holiday and volunteer time, flexible & hybrid work policies (depending on role), and vacation buy / sell program + **Financial:** 401k matching, employee share plan with voluntary investment and Henkel matching shares, annual performance bonus, service awards and student loan reimbursement + **Family Support:** 12-week gender neutral parental leave (up to 20 weeks for parents giving birth), fertility support, adoption & surrogacy reimbursement, discounted child and elderly care, and scholarships + **Career Growth:** diverse national and international growth opportunities, access to thousands of skills development courses, and tuition reimbursement The salary for this role is $70,000.00 - $80,000.00. This is the range that we in good faith anticipate relying on when setting wages for this position. We may ultimately pay more or less than the posted range and this range. This salary range may also be modified in the future. Henkel does not accept unsolicited resumes from search firms or employment agencies. Unsolicited referrals and resumes are considered Henkel property and therefore, Henkel will not pay a fee for any placement resulting from the receipt of an unsolicited referral. Henkel is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information, and other legally protected categories. **JOB ID:** 25089848 **Job Locations:** United States, CT, Stamford, CT **Contact information for application-related questions:** ***************************** Please do not use this email address for sending your application or CV. To apply, please click on the "Apply for this role" button below. Applications sent via e-mail will not be accepted. **Application Deadline:** As long as the vacancy is listed on our Career Site, we are happy to receive your application **Job-Center:** If you have an application already, you can create or log in to your accounthere (******************************************************************************************************************************************************** to check the status of your application. In case of new account creation, please use your email address that you applied with.

Apply today and become a valuable member of our Modivcare PDN Family! Care Finders Total Care, a Modivcare Personal Care Service, is looking for an RN or LPN responsible for providing high-quality services to our home care private duty clients. Position Spotlight... Pay: LPN hourly rate $35 , RN hourly rate $40 Schedule: 2 days per week Mon & Tues 7:30a-5p Area of Coverage: North, Central, South New Jersey Full Time Benefits Package if eligible: See below more details. You will... Conduct initial home visits to assess patient needs. Provide skilled nursing care following Patients Physicians Orders, Medication profile/sheet. Document daily clinical notes and progress updates on the patient's clinical record Communicate with a patient's physician and other healthcare professionals to ensure delivery of appropriate patient care. We are excited to speak to someone with the following… RN or LPN with at least 1 year of experience preferred. Experience in Home Healthcare preferred. Strong clinical judgment and critical thinking skills to make effective decisions with ability to adhere to Company/State/Regulatory requirements· We value our team members and realize the importance of benefits for you and your family. Modivcare offers Full Time or variable hour employees working an averaged 30 hours per week a comprehensive benefits package including the following: Medical, Dental & Vision Insurance 401(k) with a 6% match Paid Time Off Employee Assistance Program Employee Discounts (retail, hotel, food, restaurants, car rental, and much more!) Voluntary Term Life and AD&D Insurance Legal Services Insurance Short-Term and Long-Term Disability Accident, Critical Illness & Hospital Indemnity Insurance We live and lead by our Values… • We treat everyone with dignity and RESPECT • We earn the TRUST of our members, and each other • We provide RELIABLE services that open doors • We serve with courtesy and COMPASSION • We prioritize SAFETY • We communicate with purpose and TRANSPARENCY Modivcare. Because we care...always. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

We are seeking a Manager, Clinical Scientist to join our team. The Manager Clinical Scientist assists in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Manager works in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Manager reports to the Associate Director/Director Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. **As a Manager within Clinical Sciences, a typical day may include the following:** + Member of the Clinical Study Team and the Global Clinical SubTeam; regularly attends and actively participates in study team meetings + May contribute to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments + Develops/maintains basic understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and limited knowledge of disease and drug landscape + Applies basic scientific expertise to support execution of clinical research and development studies for early and/or late stage assets + May assist with preparation of documents related to trials, such as medical monitoring plans, SAPs, informed consents, clinical components of the Clinical Study Reports and regulatory documents; collaborate with others for scientific and foundational guidance + Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + May contribute to preparations for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority) + Supports clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety + Supports identification of data trends and potential inconsistencies in data across assigned studies and raises + Exhibits basic research and analytical knowledge to understand how study objectives and design impact data analysis; supports identification of critical risks and mitigations to study **This role may be for you if:** + Demonstrated basic knowledge of the drug development process, Good Clinical Practice, study design and clinical research methodology; beginner level medical writing skills + Demonstrate some ability to influence within study team + Independently resolves most issues and complex matters, requiring advanced analytical skill, training and/or education. Raises highly complex problems or out-of-policy issues + Strong management, interpersonal and problem-solving skills + Proven track record in clinical trial process improvements + Considerable organizational awareness, including significant experience working cross-functionally To be considered for this role, you must have a BS/MS/PhD/PharmD in a related area. Additionally, ≥ 6 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. We are seeking experience in immune/inflammatory related clinical trials. Basic knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. (1 or 2) Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. **Salary Range (annually)** $128,600.00 - $210,000.00

Under general supervision, coordinates clinical research protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality.t. Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Associates degree in Business, Public Health, or Health Education, and one to three years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred. Previous experience in clinical research or clinical trials coordination program management preferred.

Under general supervision, coordinates clinical research protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality.t. Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Associates degree in Business, Public Health, or Health Education, and one to three years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred. Previous experience in clinical research or clinical trials coordination program management preferred.