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  • Clinical Research Associate

    Insight Global

    Clinical research coordinator job in New York, NY

    **This role will onsite 5x week in NYC - part time 25-30 hours per week** Required Experience: BILINGUAL - conversational Spanish · Bachelor's degree, preferably in science, public health, health education, or a related field · Prior experience in healthcare or research settings · Prior patient education experience · Knowledge of research methodologies, protocols, and regulatory requirements · Attention to detail and a commitment to maintaining accurate and confidential patient records · Proficiency in using electronic health records (EHR) systems and other relevant software applications (eg, REDCap, Qualtrics), including qualitative research tools (eg, Dedoose, Atlas.ti) · Compassionate and patient-centered approach to care, with a commitment to ensuring patient safety and well-being Job Responsibilities: · Assist coordinators with daily participant-related tasks. · Recruit and screen potential patients/subjects for study eligibility. · Schedule and confirm participant visits. · Maintain regular contact with patients; send visit reminders and encourage compliance with research protocols. · Interact with patients, subjects, and their families in a courteous, professional, and cooperative manner. · Ensure all communication with participants is effective and respectful. · Collaborate with various personnel involved in different aspects of the study. · Ensure all protocol compliance, including adherence to eligibility criteria, follow-up procedures, and documentation standards. · Assist with regulatory procedures required by the NYU Institutional Review Board (IRB) and external IRBs to maintain approvals for human subjects research. · Utilize established quantitative and qualitative methodologies to collect research data from patients, partners, staff, and/or trainees. · Gather, compile, and input clinical and nonclinical data into databases or case report forms. · Maintain a thorough understanding of research studies and associated procedures. · Ensure compliance with study protocols and address any issues that arise.
    $53k-83k yearly est. 3d ago
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  • Director, Clinical Research Scientist

    Cellectis

    Clinical research coordinator job in New York, NY

    Cellectis' Clinical Sciences (CS) organization is seeking a highly motivated and experienced clinical Research Scientist to support the both the development and execution of our innovative proprietary UCART allogeneic CART cell therapies programs. The Director, Clinical Research Scientist participates in design and implementation of the development strategy and supports the Clinical Science Physicians with various deliverables necessary for effective and efficient planning and execution of their assigned program. Additionally, the successful candidate in this role would also be responsible for working closely with the Clinical Operations Team to support the development of clinical development processes, templates and potentially training and management of junior clinical research scientists. Job Responsibilities Supports the clinical development of assigned programs and participates and supports the design and implementation of the development strategy Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA) The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience May co-lead study team meetings in partnership with Clinical Operations study lead Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums, act as primary point-of-contact for clinical study or program for clinical science related activities, and providing clinical science inputs into study safety reporting. Clinical Scientists are likely to have regular external interactions with a variety of internal and external partners and stakeholders, such as cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups. They may also, alongside the Clinical Sciences Physician, participate in external interactions with health authorities (HAs) Provides strategic clinical science support for assigned studies and programs Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required May author and/or review clinical narratives in conjunction with pharmacovigilance in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion in concert with Clinical Science Physicians In concert with Clinical Sciences Physicians provide clinical contributions to internal documents and presentations including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts) As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists Where applicable, may manage one or more direct reports and is, in such instances responsible for hiring, training, developing, and retaining talent on his/her staff. As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment Core Competencies Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally Outstanding written communication skills Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points Comfortable working in fast paced entrepreneurial environment Ability to travel up to 20% Education and Experience Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred) Minimum of 5 years pharma/biotech industry experience in clinical development in oncology/hematology clinical trials experience in CAR T-cell therapy is preferred Experience in data review, data cleaning, managing and interpreting clinical trials results as well as exposure to writing protocols Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research Physical Requirements In office 4 days per week, required Sedentary, desk position Salary Range $175,000-225,000 (final salary is dependent on candidate's experience and credentials)
    $175k-225k yearly Auto-Apply 60d+ ago
  • UX Research Coordinator

    Northwestern Mutual 4.5company rating

    Clinical research coordinator job in New York, NY

    About the Job: The Research Coordinator's role is to help the research practice operate more efficiently. They do this by handling the logistics to make research run smoothly so that researchers can focus on what they do best - conduct research. Research Coordinator duties may include project and client management, creating and managing materials for research, participant recruitment and session scheduling, incentive management, tool and data management, etc. What You'll Do: * Coordinate research participant recruitment * o Identify and recruit research participants per researcher specifications * o Coordinate schedules of research participants, researchers, and stakeholders * o Manage incentives * o Manage lists of past and future research participants * Manage software systems used for data collection and analysis * Coordinate with Design Program Managers, Design Leads, and other stakeholders * Work as part of the larger Design Operations team and may be called upon to do operational work for the broader design organization. * If capacity allows, manage projects across the research organization. Including * o Prepare study materials and data collection tools for research sessions * o Schedule planning, research, and report-out sessions for researchers * o Prepare data for analysis * o Create and manage data repositories and handle records retention Skills You Have: * Bachelor's degree, or equivalent * Experience providing operational support to fast-paced research teams. * Experience with research participant recruitment * Demonstrated skills in increasing team efficiency. * Strong communication and organizational skills with attention to the right details to ensure operations run smoothly * An ability to anticipate and proactively solve logistical issues so your team knows they'll never miss a beat when you're coordinating their work Additional Qualifications We'd Love: * 2 years' experience collaborating with live research teams. * Experience working in a highly regulated environment like healthcare or financial services. * Professional association with the Research Ops community. #LI-Hybrid Compensation Range: Pay Range - Start: $60,340.00 Pay Range - End: $112,060.00 Geographic Specific Pay Structure: Structure 110: $66,360.00 USD - $123,240.00 USD Structure 115: $69,370.00 USD - $128,830.00 USD We believe in fairness and transparency. It's why we share the salary range for most of our roles. However, final salaries are based on a number of factors, including the skills and experience of the candidate; the current market; location of the candidate; and other factors uncovered in the hiring process. The standard pay structure is listed but if you're living in California, New York City or other eligible location, geographic specific pay structures, compensation and benefits could be applicable, click here to learn more. Grow your career with a best-in-class company that puts our clients' interests at the center of all we do. Get started now! Northwestern Mutual is an equal opportunity employer who welcomes and encourages diversity in the workforce. We are committed to creating and maintaining an environment in which each employee can contribute creative ideas, seek challenges, assume leadership and continue to focus on meeting and exceeding business and personal objectives.
    $60.3k-128.8k yearly Auto-Apply 44d ago
  • Clinical Research Associate II

    Allen Spolden

    Clinical research coordinator job in New York, NY

    Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K
    $53k-83k yearly est. 60d+ ago
  • Clinical Research Scientist

    Mitsubishi Tanabe Pharma America 4.1company rating

    Clinical research coordinator job in Jersey City, NJ

    Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off
    $75k-125k yearly est. 3d ago
  • Clinical Research Scientist - Breast Cancer Franchise

    Eli Lilly and Company 4.6company rating

    Clinical research coordinator job in Stamford, CT

    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 stay in sync 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. * Lead and contribute 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. * Partake 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 strategy 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 and experience in Health-related field with 10+ years' industry experience * 3+ years of clinical research scientist experience/clinical trial experience * Leadership experience Additional Information/Preferences: * Direct Line Leadership experience 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. * 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
    $83k-111k yearly est. Auto-Apply 58d ago
  • Clinical Study Coordinator/Specialist

    Henkel 4.7company rating

    Clinical research coordinator job in Stamford, CT

    **_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. Activate external content When clicking the button below external content will be loaded which involves transfer of personal data (e.g. IP address) to external servers. This may involve that cookies are set by the external content provider. Please see Data Protection Statement for further information. **Accept for all YouTube content** Deactivate loading external content from YouTube. How is work at Henkel
    $70k-80k yearly Easy Apply 27d ago
  • Clinical Research Associate

    Nymc

    Clinical research coordinator job in Hawthorne, NY

    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.
    $48k-60k yearly Auto-Apply 60d+ ago
  • Clinical Research Coordinator I (Yonkers, NY)

    Care Access 4.3company rating

    Clinical research coordinator job in Yonkers, NY

    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 to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The 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 for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $55k-85k yearly 28d ago
  • Clinical Research Coordinator

    Actalent

    Clinical research coordinator job in Hoboken, NJ

    The Clinical Research Coordinator plays a pivotal role in the execution of clinical trials by utilizing Good Clinical Practices (GCP) to screen, enroll, and monitor study subjects while ensuring compliance with protocols and regulations. Responsibilities + Prioritize activities according to protocol timelines. + Maintain adherence to FDA regulations and ICH guidelines throughout the clinical trial process. + Foster effective relationships with study participants and research personnel. + Interact professionally with patients, sponsor representatives, investigators, and management. + Coordinate and attend pre-study site visits, site initiation visits, and monitor visits. + Identify and report adverse events and serious adverse events promptly. + Prescreen study candidates and obtain informed consent. + Conduct visit procedures in alignment with protocol guidelines. + Train others and perform basic clinical procedures such as blood draws and ECGs. + Review laboratory results and test outcomes for completeness and alert values. + Discuss study medication and required procedures with the Investigator and site staff. + Record data legibly and enter it in real-time on paper or electronic sources. + Manage study medication inventory and patient compliance accurately. + Resolve data management queries within sponsor-provided timelines. + Assist with regulatory documentation and source document creation. + Contribute to recruitment planning and material development. + Work with recruitment teams to actively recruit subjects. + Review and assess protocol amendments for clarity and feasibility. + Ensure training and study requirements are met before trial conduct. + Attend Investigator meetings as required. + Ensure adequate supply availability for protocol initiation. Essential Skills + Strong understanding of institutional SOPs. + Excellent knowledge of medical and research terminology. + Familiarity with federal regulations and good clinical practices (GCP). + Effective communication and teamwork skills. + Strong organizational and leadership capabilities. + Attention to detail. + Proficiency with clinical trial databases, IVR systems, and EDC. + Critical thinking and problem-solving abilities. + Positive attitude and high level of motivation. + Professional writing and communication skills. + Ability to work independently in a fast-paced environment. Additional Skills & Qualifications + Bachelor's Degree preferred or equivalent combination of education and experience. + Minimum of 3 years of prior Clinical Research Coordinator experience required. + Recent phlebotomy experience required. Work Environment The position is based in an on-site clinic environment, providing opportunities to engage directly with patients and research personnel in a dynamic setting. Job Type & Location This is a Permanent position based out of Hoboken, NJ. Pay and Benefits The pay range for this position is $75000.00 - $80000.00/yr. Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Workplace Type This is a fully onsite position in Hoboken,NJ. Application Deadline This position is anticipated to close on Jan 14, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
    $75k-80k yearly 8d ago
  • Junior Clinical Research Coordinator - Oncology

    Vitalief

    Clinical research coordinator job in Newark, NJ

    Vitalief is a consulting and professional services firm that partners with clinical research sites, sponsors, and CROs to enhance trial activation, operational performance, and workforce readiness. Our approach combines deep clinical research expertise with operational excellence and business acumen, enabling organizations to work more efficiently. We help clients streamline processes, reduce costs, accelerate timelines, and ultimately improve patient outcomes. THE ROLE We are seeking an experienced Clinical Research Coordinator to join our team as a full-time Vitalief employee. In this role, you will support a leading academic research center in Newark, NJ, managing high-priority interventional oncology clinical studies across multiple disease groups. WHY VITALIEF? Contribute to advancing scientific discoveries that improve patient lives. PEOPLE FIRST culture with opportunities for growth and innovation. Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans. Work schedule: 5 days per week on-site (Newark, NJ) initially; potential for 1 day remote weekly after acclimation. Market-competitive salary, $45,000 to $50,000 (commensurate with experience). RESPONSIBILITIES: Under the direction of the Clinical Research Study Site Leader, support the planning, implementation, and execution of multiple concurrent Medical Oncology interventional studies (Phase II-III). Studies are largely drug and biologic trials that may include radiation and surgical components. Independently manage day-to-day clinical research activities across the full study lifecycle, from start-up through close-out. Collaborate closely with principal investigators, clinical care teams, and ancillary departments (e.g., pathology, radiology, clinical laboratory, surgery, and infusion services) to ensure protocol adherence, patient safety, and compliance with Good Clinical Practice (GCP) guidelines. Support investigators in the preparation and activation of new clinical trials, including feasibility assessments, patient screening, enrollment, and ongoing protocol-driven clinical management and retention of study participants. Coordinate and conduct participant study visits; maintain study databases; and ensure accurate, timely data collection and entry. Manage regulatory documentation, including regulatory binders, IRB submissions, amendments, continuing reviews, and compliance with FDA, IRB, and GCP requirements. Identify, assess, document, and report adverse events and serious/unexpected adverse events (SAEs) in accordance with protocol and regulatory requirements. Consistently meet or exceed study enrollment and retention targets. Monitor participant safety, prepare required study reports, and support sponsor monitoring visits, audits, and inspections. Maintain accurate study records within Clinical Trial Management Systems and institutional platforms (e.g., OnCore, Epic, ClinicalTrials.gov), including oversight of research billing reviews. REQUIRED SKILLS: Bachelor's degree required (healthcare, life sciences, or related field preferred). Minimum of one (1) year of clinical research coordination experience; academic or institutional research site experience strongly preferred. Prior experience supporting oncology clinical trials strongly preferred. Phlebotomy certification or willingness to obtain training preferred. Working knowledge of GCP, FDA, and IRB regulations and clinical research compliance standards. Demonstrated experience with patient recruitment and retention, IRB submissions, data management, and adverse event reporting. Excellent written and verbal communication skills, with the ability to interact effectively with investigators, clinical staff, sponsors, and research participants. Strong organizational and time-management skills; ability to manage multiple studies and competing priorities in a fast-paced environment. Proactive, adaptable, and self-motivated, with strong critical thinking and prioritization skills. Compassionate, professional demeanor with strong patient-facing skills and the ability to translate complex clinical information into clear, patient-friendly language. Proficiency in Microsoft Office applications (Word, Excel, PowerPoint). Experience with Electronic Health Records (Epic preferred) and Clinical Trial Management Systems (OnCore preferred). PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.
    $45k-50k yearly Auto-Apply 9d ago
  • Study participant - US (EST)

    Prolific 4.2company rating

    Clinical research coordinator job in New York, NY

    Study Participants Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world. Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills. The role We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects. Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter. What you'll bring A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable) A willingness to take our screening to assess your suitability for our participant pool Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time A reliable and fast internet connection and access to a computer A willingness to self-declare your earnings, as our participants are self-employed A Paypal account to receive payment from our clients What you'll be doing in the role Completing paid research studies such as answering surveys, participating in experiments, and providing written responses Providing feedback, judgements, and opinions in structured research tasks Contributing to high-quality research outcomes by responding thoughtfully and accurately Key study types Surveys and Questionnaires Behavioural Experiments User Research and Product Feedback Educational and Academic Studies Interviews and Open-Ended Responses Quality Checks and Attention Tasks Why Prolific is a great platform to join as a Participant Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home. We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines. We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity. Links to more information on Prolific Website Youtube Privacy Statement By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.
    $18 hourly Auto-Apply 7d ago
  • Clinical Coordinator

    Lenox Hill Neighborhood House 4.1company rating

    Clinical research coordinator job in New York, NY

    Lenox Hill Neighborhood House, widely recognized as one of New Yorks premier human services providers, is a settlement house founded in 1894 that provides an extensive array of effective and integrated servicessocial, educational, health, housing, mental health, nutritional and fitnesswhich significantly improve the lives of 16,000 people in need each year, ages 3 to 103, on the East Side of Manhattan. Our clients include older adults, unhoused and formerly unhoused adults, children and families, disabled persons, adult learners and more. For more information on Lenox Hill Neighborhood House, please visit lenoxhill.org and check us out on Facebook or Instagram. Casa Mutua, located on East 102nd Street, is our 54-unit permanent supportive housing residence for formerly unhoused single adults living with mental health diagnoses. We have operated this building and are both the property manager and social services provider for over 30 years. Our program serves the individual needs of the clients, with a focus on recovering from the trauma of homelessness, learning independent living skills, maintaining their current housing, and moving toward greater physical and mental wellbeing. Casa Mutua offers individual counseling, crisis intervention, benefits management and assistance, referrals and linkages to medical doctors, psychiatrists, and therapists, financial management training and assistance; on-site psychiatric services, medication management, group supports and socialization. Casa Mutuas on-site and off-site recreational activities further foster a strong sense of community among residents. The Clinical Coordinator will be a critical part of the Casa Mutua team, ensuring we help to promote the independence and stability of our residents by providing comprehensive, supportive social services, recreational, case management and therapeutic programming in house and on site. Reporting to the Director, the Clinical Coordinator will have primary responsibility for providing direct social services, case management and counseling services and effectively collaborating across our multi-disciplinary team to support the best outcomes of our residents. The Clinical Coordinator will: Provide person-centered services to residents who have a history of homelessness and are living with various mental health diagnoses such as Depression, Bipolar Disorder, Schizophrenia and Anxiety Coordinate, provide and referral to psychiatric, medical and substance use services as needed Complete comprehensive intakes, biopsychosocial assessments, service plans and other required assessments and documentation with residents Provide direct therapeutic supportive services such as counseling, case management, advocacy for government benefits and services, group work and referrals to community resources Participate in treatment planning and implementation, case conferences, and weekly clinical and staff meetings, in addition to collaborating effectively with the on-site clinical and psychiatric providers Accompany clients to essential medical appointments and government offices to ensure access to needed services and support Provide crisis intervention, problem-solving and conflict resolution to resolve resident issues and conflicts Be willing to be on call with other staff on a rotating schedule Facilitate and assist with group activities, including support and social groups, monthly community meetings, and community special events and parties for residents Collaborate with staff at all levels at Casa Mutua and throughout Lenox Hill Neighborhood House to ensure quality service provision Complete all responsibilities and duties as assigned by the Clinical Director Qualifications: The ideal candidate for the Clinical Coordinator must possess excellent interpersonal, engagement and relationship-building skills to work effectively with the residents. A social justice perspective combined with a commitment to mental health and unhoused populations is required. Experience working with mental illness, substance use, and trauma-informed care and treatment are essential. The candidate must be detail-oriented and have excellent communication, technology and organizational abilities. The Clinical Coordinator must be willing to work a full-time, Monday-Friday schedule, 9am-5pm with some on-call requirements. Master's in Social Work or Counseling. Applicable Licensure and/or SIFI Certification if applicable a plus. Salary: $70,000 What We Offer Comprehensive health insurance choices for staff and their families Extensive paid time off 25 days vacation :12 holidays; and substantial sick time Matching contributions to Retirement Plan paid parental leave policy for all staff Professional Development Opportunities conferences, trainings, lectures and more Free Life Insurance 3x annual salary Pre-tax Flexible Spending Accounts for Medical, Dependent Care and Parking/Mass Transit Supplemental Insurance Coverage (Accident, Hospital and Critical Illness) Staff events and parties including Film and Dinner nights, bowling parties, baseball games, food trucks, holiday parties, parties on our Green Roof, chocolate event for Valentines Day and ice cream socials, and much more. State-of-the Art Fitness Center, Gym and Swimming Pool Staff yoga and boot camp classes (six a week), swimming lessons and lap swim for staff PSLF (Public Service Loan Forgiveness) Eligible Employer All individuals, as a condition for employment by Lenox Hill Neighborhood House, are required to undergo a pre-employment background check. Certain positions require more extensive background checks to comply with applicable laws. At Lenox Hill Neighborhood House we value respect, integrity, diversity and integrity. We are an equal opportunity employer. Lenox Hill Neighborhood House prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to 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. Lenox Hill Neighborhood House conforms to the spirit as well as to the letter of all applicable laws and regulations. The policy of equal employment opportunity (EEO) and anti-discrimination applies to all aspects of the relationship between Lenox Hill Neighborhood House and its colleagues. Compensation details: 70000-70000 Yearly Salary PI97b0fde7ae6c-31181-39283784
    $70k yearly 8d ago
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research coordinator job in New York, NY

    Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K
    $53k-83k yearly est. 60d+ ago
  • Clinical Research Scientist

    Mitsubishi Tanabe Pharma America 4.1company rating

    Clinical research coordinator job in Jersey City, NJ

    Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off
    $75k-125k yearly est. 60d+ ago
  • Clinical Study Coordinator/Specialist

    Henkel 4.7company rating

    Clinical research coordinator job in Stamford, CT

    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 account here to check the status of your application. In case of new account creation, please use your email address that you applied with. Activate external content When clicking the button below external content will be loaded which involves transfer of personal data (e.g. IP address) to external servers. This may involve that cookies are set by the external content provider. Please see Data Protection Statement for further information. Accept for all YouTube content LOAD EXTERNAL CONTENT Deactivate loading external content from YouTube. How is work at Henkel About Henkel Building on a strong legacy of almost 150 years, we are leading the way to reimagine and improve life every day. Today and for generations to come. Through our innovative and sustainable brands and technologies, across our teams around the world. Henkel holds leading positions in both industrial and consumer businesses: Our portfolio includes well-known hair care products, laundry detergents, fabric softeners as well as adhesives, sealants, and functional coatings.
    $70k-80k yearly Easy Apply 14d ago
  • Clinical Research Coordinator I (Yonkers, NY)

    Care Access 4.3company rating

    Clinical research coordinator job in Yonkers, NY

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The 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: ********************************
    $55k-85k yearly 60d+ ago
  • Clinical Research Coordinator

    Actalent

    Clinical research coordinator job in Hoboken, NJ

    The Clinical Research Coordinator plays a pivotal role in the execution of clinical trials by utilizing Good Clinical Practices (GCP) to screen, enroll, and monitor study subjects while ensuring compliance with protocols and regulations. Responsibilities * Prioritize activities according to protocol timelines. * Maintain adherence to FDA regulations and ICH guidelines throughout the clinical trial process. * Foster effective relationships with study participants and research personnel. * Interact professionally with patients, sponsor representatives, investigators, and management. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits. * Identify and report adverse events and serious adverse events promptly. * Prescreen study candidates and obtain informed consent. * Conduct visit procedures in alignment with protocol guidelines. * Train others and perform basic clinical procedures such as blood draws and ECGs. * Review laboratory results and test outcomes for completeness and alert values. * Discuss study medication and required procedures with the Investigator and site staff. * Record data legibly and enter it in real-time on paper or electronic sources. * Manage study medication inventory and patient compliance accurately. * Resolve data management queries within sponsor-provided timelines. * Assist with regulatory documentation and source document creation. * Contribute to recruitment planning and material development. * Work with recruitment teams to actively recruit subjects. * Review and assess protocol amendments for clarity and feasibility. * Ensure training and study requirements are met before trial conduct. * Attend Investigator meetings as required. * Ensure adequate supply availability for protocol initiation. Essential Skills * Strong understanding of institutional SOPs. * Excellent knowledge of medical and research terminology. * Familiarity with federal regulations and good clinical practices (GCP). * Effective communication and teamwork skills. * Strong organizational and leadership capabilities. * Attention to detail. * Proficiency with clinical trial databases, IVR systems, and EDC. * Critical thinking and problem-solving abilities. * Positive attitude and high level of motivation. * Professional writing and communication skills. * Ability to work independently in a fast-paced environment. Additional Skills & Qualifications * Bachelor's Degree preferred or equivalent combination of education and experience. * Minimum of 3 years of prior Clinical Research Coordinator experience required. * Recent phlebotomy experience required. Work Environment The position is based in an on-site clinic environment, providing opportunities to engage directly with patients and research personnel in a dynamic setting. Job Type & Location This is a Permanent position based out of Hoboken, NJ. Pay and Benefits The pay range for this position is $75000.00 - $80000.00/yr. Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Workplace Type This is a fully onsite position in Hoboken,NJ. Application Deadline This position is anticipated to close on Jan 14, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $75k-80k yearly 8d ago
  • Clinical Research Associate II

    Allen Spolden

    Clinical research coordinator job in Newark, NJ

    Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K
    $53k-83k yearly est. 60d+ ago
  • Clinical Research Coordinator I

    Care Access 4.3company rating

    Clinical research coordinator job in New York, NY

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The 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 New York, NY * 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 for full time team members. Benefits & Perks (US Full Time Employees) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $55k-85k yearly 25d ago

Learn more about clinical research coordinator jobs

How much does a clinical research coordinator earn in Franklin Square, NY?

The average clinical research coordinator in Franklin Square, NY earns between $41,000 and $86,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.

Average clinical research coordinator salary in Franklin Square, NY

$60,000

What are the biggest employers of Clinical Research Coordinators in Franklin Square, NY?

The biggest employers of Clinical Research Coordinators in Franklin Square, NY are:
  1. Northwell Health
  2. OCLI
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