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Clinical research coordinator jobs in Goshen, NY - 122 jobs

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Clinical Research Coordinator
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Clinical Research Monitor
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Clinical Associate
  • Weights and Research Coordinator

    R+L Carriers 4.3company rating

    Clinical research coordinator job in Maybrook, NY

    Full-Time Monday-Friday, Various shifts Salary range $60,000-$65,000 per yr Come and experience the difference with R+L Carriers Earn 1 week of vacation after 90 days of employment Click here to learn more about our employee resorts Company Culture Requirements: Any type of LTL experience preferred but not required Ability to self-motivate and self-manage Willingness to learn Analytical skills Computer proficiency Able to work in a fast-paced environment Excellent Benefits R+L Carriers offers an excellent compensation and comprehensive benefits package, including Medical/Dental/Vision Insurance, 401(k) Retirement Plan with matching contributions, Paid Vacation & Holidays, and vacation lodging at our exclusive employee resorts in Daytona Beach, FL, Big Bear Lake, CA, Pigeon Forge, TN and Ocean Isle Beach, NC. Click here ****************************
    $60k-65k yearly Auto-Apply 6h ago
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  • Research Coordinator

    Regional Cancer Care Associates 4.2company rating

    Clinical research coordinator job in Sparta, NJ

    Are you ready to be a pivotal force in groundbreaking cancer research? RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management. We're seeking someone with a knack for multitasking, a positive outlook, and an undeniable passion for making a difference. If you're eager to join a team that's leading the charge in cutting-edge cancer care and places the patient at the forefront, we want to hear from you! Employment Type: Full Time Location: Sparta, NJ Compensation: $27.09 - $36.54 per hour Compensation packages based on your unique skills, experience, and qualifications As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities. We believe these benefits underscore our commitment to the well-being and professional growth of our employees. ESSENTIAL DUTIES AND RESPONSIBILITIES: Demonstrate understanding of the protocol elements and requirements. Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality. Screening, recruit, enroll prospective patients using EMR, EDC, CTMS Create and maintain enrollment logs for each trial from beginning to end Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial. Collaborates with the cross functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistances, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial. Oversee study kits, study drug accountability records, study kits/IMP drug destruction and maintenance. Enter all the data to EDC, and EMR within 24 hours of data collection. Communicate and resolve all the data queries within 5-days Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator. Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug ice storage for the specimens, temperature logs and other required essential documents Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times. Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements. Interacts with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues. Supports internal and external audits Ability to take initiative to resolve protocol-related concerns and discrepancies. Generate solutions to barriers and opportunities for improvements. Centrifuge, process, prepare, ship, and store biological materials by the sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions. Conduct clinical trial weekly and monthly meetings within the division. Require attending SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings. Track and submit clinical trial patient reimbursement. Other duties as assigned. Requirements Minimum Job Qualifications: Minimum 1 year of experience with oncology interventional clinical trials. ACRP (CCRC, CCRA) or SoCRA (CCRP) Certified Clinical Research Professional with one year of oncology trial experience. High School diploma with four years of oncology clinical trial experience. Computer literate with good interpersonal, writing, and verbal communication skills. Previous regulatory affairs experience is a plus. Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm in all RCCA network. Prior experience working with centrifuge and handling biofluid specimens is preferred. Ability to multi-task and prioritize in a fast-paced work environment, time management skills, and ability to work well under pressure. Working Conditions: Traditional office environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements (Lifting, standing, etc.) Large percent of time performing computer based work is required The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. Salary Description $27.09 - $36.54
    $27.1-36.5 hourly 60d ago
  • Clinical Research Associate - Sponsor Dedicated

    Iqvia 4.7company rating

    Clinical research coordinator job in Parsippany-Troy Hills, NJ

    Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications • Bachelor's Degree Degree in scientific discipline or health care preferred. Req • Requires at least 1 year of on-site monitoring experience. Req • Equivalent combination of education, training and experience may be accepted in lieu of degree. Req • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines). • Good therapeutic and protocol knowledge as provided in company training. • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). • Written and verbal communication skills including good command of English language. • Organizational and problem-solving skills. • Effective time and financial management skills. • Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
    $71.9k-169.3k yearly Auto-Apply 60d+ ago
  • Clinical Research Scientist (EZIJP00002334)

    Artech Information System 4.8company rating

    Clinical research coordinator job in Woodcliff Lake, NJ

    Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications. At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources. Job Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, Client, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications BS/MS Additional Information For more information, Please contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960
    $79k-116k yearly est. 10h ago
  • Clinical Research Scientist

    Integrated Resources 4.5company rating

    Clinical research coordinator job in Woodcliff Lake, NJ

    Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Title: Clinical Research Scientist Duration: 12 Months (Possibility of Extension) Location Woodcliff lake NJ Job Responsibilities: The incumbent is responsible for, but not limited to the following: Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) Performs literature search and data analysis to address research questions In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) Assisting in database cleaning, review of study results, and interpretation of results Adhering to key performance indicators for clinical study development, conduct, and reporting Individual contributor with specialized knowledge Presents concepts, facts, and reports and advises on key trends and issues Troubleshooting routine site inquiries Work is completed under limited supervision Supports the planning, execution and reporting of clinical programs/trials May handle multiple protocols simultaneously Contributes to risk resolution by escalating and monitoring project risks Qualifications Qualifications Minimum of 2-5 years of experience in clinical research in the pharmaceutical industry A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; Bachelor's Required. Doctoral (PharmD or PhD) or MD degree preferred. Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus Thank you for your time and consideration. I look forward to hearing from you! Kind Regards Ruchi Kumari Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I (DIRECT BOARD) # 732-844-8716 (F) 732-549-5549 LinkedIn: https://www.linkedin.com/in/ruchi-kumari Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
    $77k-115k yearly est. 60d+ ago
  • Clinical Research Associate

    Touro University 4.4company rating

    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 Associate

    Millenniumsoft 3.8company rating

    Clinical research coordinator job in Franklin Lakes, NJ

    Clinical Research Associate Duration : 12 +months contract Start Time : 08:00 AM End Time : 05.00 PM Total Hours/week : 40.00 Qualifications: The Clinical Research Associate (CRA) is responsible for planning, negotiating, conducting, monitoring, and reporting on clinical trials. The CRA is responsible for protocol development, site selection and qualification, preparing Informed Consent materials, contracting, training, site monitoring, and study document management. The CRA collaborates with data management and statistics groups to ensure accuracy and integrity of study data. The CRA is responsible for preparing reports of study results for investigators and internal development teams, assisting in preparation of regulatory submissions, and supporting publication activities. The CRA will interface with appropriate internal individuals to manage trials in order to meet business objectives and timelines, provide clinical and technical support to product development activities, support product launches, and/or conduct post-market surveillance and evaluation activities. Responsibilities: Responsible for planning, budgeting, executing, and monitoring clinical evaluations of BD products to support product development. Clinical evaluations may also be for post-market surveillance studies, or claims extensions of existing products. Provide product development teams and other functions with technical and clinical expertise and support. Activities will be performed in accordance with international, federal and/or local regulations (FDA, ISO), Good Clinical Practices (GCPs), and compliance with corporate and local quality policies and procedures. Specific Responsibilities: Develop the study design and protocol(s) Screen, select, and qualify principal investigators and investigational sites Conduct negotiations of clinical site agreements and contracts Ensure the compliance to all human subject protection and privacy regulations, including developing Informed Consent materials Develop time schedules and budgets necessary to manage the clinical evaluations Coordinate and plan availability of supplies and shipment of materials Train clinical evaluation participants in study products and procedures. Monitor sites to assure that the Protocol is understood and followed Collect, review, analyze, and report data generated during clinical evaluations in a timely manner, through interactions with Clinical Database/Statistics Communicate results of data analysis to each clinical center, project teams and applicable functions within BD, and actively support the publication and presentation of results by investigators Support the reporting of performance data to regulatory authorities Assumes responsibility for occasional special departmental projects Anticipate 10% to 25% travel (primarily domestic; international travel a possibility
    $50k-82k yearly est. 60d+ ago
  • Clinical Research Scientist

    Lancesoft 4.5company rating

    Clinical research coordinator job in Woodcliff Lake, NJ

    Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits. I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization. Job Description Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/ CTD/ MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry Additional Information All your information will be kept confidential according to EEO guidelines.
    $78k-121k yearly est. 10h ago
  • Manager, Clinical Research

    NS Pharma Inc.

    Clinical research coordinator job in Paramus, NJ

    Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Manage and support the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. Essential Duties and Responsibilities: Assist to plan, implement, manage and report for regional or global clinical studies. Manage selection process of CROs for regional or global clinical studies. Manage the performance of study vendors (e.g. CROs and central labs) Manage activities for clinical site selection, investigator meetings and study initiation. Oversight of patient recruitment and development of recruitment strategies and plans Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.) Tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans. Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols. Coordinate negotiation of clinical trial contracts between investigational sites and CROs. Manage assigned vendors to ensure timely analysis output delivery in accordance with vendor-specific plan. Support coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites. Implement project specific training program and training materials Support creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes. Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.). As needed and required perform other tasks and functions. Qualifications: Must be able to manage and coordinate with the Clinical Lead and Study Manager to achieve project objectives and able to manage/solve project management performance issues if they arise. Demonstrated ability to support the development and management of various aspects of the end to end study operational plan. Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners and vendors. Thorough understanding of clinical operations involved as related to the planning, conducting, and closing clinical studies. Ability to handle multiple tasks and prioritize. Strong organizational, communication and presentation skills. Team player, flexible, ability to adapt to change. Must be able to travel within the US and outside of US 15-25% monthly and interact with Investigators in-person regarding the protocol and study drug. Education and Experience: Bachelor's Degree in sciences or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience. Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. Program and project management experience preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $110,000 to $135,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs Discretionary Bonus Programs and Long-term Incentive Plan Retirement Savings 401k with company match Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown. Career Development, Progression and Training Flexible Work Arrangement Programs Applications will be accepted until January 19, 2025, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.
    $110k-135k yearly 27d ago
  • Research Program Coordinator II, Research - Clinical Trials, Full Time, Day

    The Valley Hospital 4.2company rating

    Clinical research coordinator job in Paramus, NJ

    The Research Program Coordinator II (RPC II) provides administrative, operational, and programmatic support services to manage the research portfolio for The RPC II will join a highly collaborative team of investigators to examine specific diseases processes using electronic health record (EHR) data. Candidate must be able to independently conduct research including statistical analyses and prepare manuscripts and abstracts for dissemination. Education Bachelor's degree required, preferably in a healthcare, science, or data-focused field. Proficiency in Microsoft Word, Excel, PowerPoint, Teams and Outlook is required. Experience with statistical analysis and software such as SPSS, REDCap is preferred. Familiarity with electrophysiology clinical workflows, research practices, or electronic health records is desirable. Experience Bachelor's degree or equivalent plus 5 years of related experience, OR Master's candidate with 2 years of related experience and at least 1 year experience of data collection and analysis. Completion and maintenance of Human Subjects Research training/certifications via the CITI program. Special Skills/Qualifications Excellent verbal and written communication skills. This includes strong writing skills. Computer proficiency with excellent data management and data analysis skills are also required. Experience with Redcap/SPSS and/or other statistical software programs is helpful. Ability to communicate, interpret, share and present information to leadership, staff and lay audiences. Strong organizational skills and appreciation for detail and quality is an essential skill for the position. Achieves subject matter proficiency by reading and synthesizing pertinent literature. Familiarity with topics pertaining to health care delivery, health policy, public health, and/or acute care. Proficiency with the Microsoft Office Product Suite (including Word, Excel, PowerPoint, Outlook) Job Location Paramus 140 E Ridgewood Ave Shift Day (United States of America) Benefits Medical/Prescription, Dental & Vision Discount Program (Full Time/Part Time Employees) Group Term Life Insurance and AD&D(Full Time Employees) Flexible Spending Accounts and Commuter Benefit Plans Supplemental Voluntary Benefits ( e.g. Short-term and Long-term Disability, Whole Life Insurance, Legal Support, etc.) 6 Paid Holidays, Paid Time Off (varies), Wellness Time Off, Extended Illness Retirement Plan Tuition Assistance Employee Assistance Program (EAP) Valley Health LifeStyles Fitness Center Membership Discount Day Care Discounts for Various Daycare Facilities SalaryJoining Valley Health System means becoming part of a dedicated team that values the highest quality of care in a supportive environment. In our commitment to high performance and reliability, we encourage and recognize exceptional individual performance through our industry leading compensation practices including a starting salary and benefits in accordance with your role, experience, education, and licensure. Actual individual salaries vary depending on these factors. The salary listed does not include other forms of compensation or benefits.Pay Range: $32.36 - $40.45 (per hour) EEO Statement Valley Health System does not discriminate on the basis of ancestry, age, atypical hereditary cellular or blood trait, civil union status, color, creed, disability, domestic partnership, gender, gender identity or expression, familial status, genetic information, liability for service in the Armed Forces of the United States, marital status, medical condition or illness, mental or physical handicap, national origin, nationality, perceived disability, pregnancy, race, refusal to submit to genetic testing or make available results of such tests, religion, sex, sexual orientation, veteran's status or any other protected basis, in accordance with all applicable Federal, State and Local laws. This applies to all areas of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoff, compensation, benefits, social and recreational programs, and all other conditions and privileges of employment.
    $32.4-40.5 hourly Auto-Apply 32d 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 - Cancer Institute - Poughkeepsie, NY

    Danbury Hospital 4.7company rating

    Clinical research coordinator job in Poughkeepsie, NY

    at Vassar Brothers Medical Center Full-time Clinical Research Coordinator, Poughkeepsie, NY (On-site) Monday - Friday, 8:30 am - 5:00 pm Purpose: Coordinates clinical research activities within the research division through the use of Good Clinical Practice Guidelines. Essential Responsibilities: Function independently in a clinical research setting and responsible for the complete coordination of assigned clinical research protocols from national research agencies and pharmaceutical corporations. Assists investigators, research and, medical center staff with the initiation of research protocols. Ensures accurate and timely communication is facilitated, presenting the research division in a positive manner. Supports the management of clinical research databases to ensure records are accurately and timely maintained. Demonstrates regard for the dignity and respect of medical center personnel and community residents as defined in the philosophy of HVCVP or Vassar Brothers Medical Center. EKG's, body measurements. Maintain and Model REACH Values (Respect, Excellence, Accountability, Compassion, Honor). Demonstrates regular, reliable and predictable attendance. Performs other duties as required. Requirements: Bachelor's Degree, Allied health professional degree, or equivalent experience. Minimum of one-two (1-2) years' experience with EDC and CRFs. Minimum Knowledge, Skills and Abilities Requirements: Ability to multi-task and work as a team and independently. Knowledge of Medical Terminology, good clinical practice, FDA, OHRP, and HIPAA policies. Outstanding interpersonal communication skills. Strong attention to detail, self-motivation, and good organizational skills. Ability to prioritize quickly and follow directions and protocol. License, Registration, or Certification Requirements: Basic Life Support (BLS) certified or willing to obtain upon employment. Valid driver's license and reliable transportation. PREFER: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or certified within 2 years. Environmental Factors: Bio-hazardous Waste Chemicals/Commercial Products Exposure to Latex Interacting with a Diverse population Patient Care/Handling Duties Risk of Electrical Shock Physical & Mental Requirements: Repetitive Motion Noise Level - Varies from Quiet to Very Loud Fumes or Airborne Particles Experiencing challenging conditions where a professional attitude will be required Blood Borne Pathogens. Job may require performance or tasks that involve potential for exposure to blood, body fluids, or tissues. Location: Poughkeepsie-28 Reade Place Salary Range: $27.9072 - $51.8262 hourly, commensurate with experience Working conditions: Essential: * Some manual skills / motor coord & finger dexterity * Little or no potential for occupational risk * Sedentary/light effort. May exert up to 10 lbs. force * Generally pleasant working conditions. EOE, including disability/vets. We will endeavor to make a reasonable accommodation to the known physical or mental limitations of a qualified applicant with a disability unless the accommodation would impose an undue hardship on the operation of our business. If you believe you require such assistance to complete this form or to participate in an interview, please contact Human Resources at ************ (for reasonable accommodation requests only). Please provide all information requested to assure that you are considered for current or future opportunities. About Nuvance Health Nuvance Health has a network of convenient hospital and outpatient locations - Danbury Hospital, New Milford Hospital, Norwalk Hospital and Sharon Hospital in Connecticut, and Northern Dutchess Hospital, Putnam Hospital Center and Vassar Brothers Medical Center in New York - plus multiple primary and specialty care physician practices locations, including The Heart Center, a leading provider of cardiology care, and two urgent care offices. Non-acute care is offered through various affiliates and the Home Care organizations.
    $27.9-51.8 hourly Auto-Apply 60d+ ago
  • Clinical Trials Coordinator

    St. Joseph's Healthcare System 4.8company rating

    Clinical research coordinator job in Paterson, NJ

    Under general supervision, coordinates clinical research protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality.t. Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Associates degree in Business, Public Health, or Health Education, and one to three years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred. Previous experience in clinical research or clinical trials coordination program management preferred.
    $50k-67k yearly est. Auto-Apply 2d ago
  • Sr. Clinical Trial Study Manager - Oncology

    Syndicus

    Clinical research coordinator job in Parsippany-Troy Hills, NJ

    Whippany, NJ Sr. Study Manager Job description The incumbent will: •Manages and is responsible for all activities related to clinical pharmacology, complex phase I, extended phase I/IIa oncology clinical trials from the approved study concept to the clinical study report. •Manages all Study Team activities as defined per SOPs/OIs and ensures the organization of regular Study Team meetings •Manages the selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.) •Develops and manages budget, timelines and quality of the study and its deliverables. Responsible for forecasting and tracking of study costs. Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT) •Responsible for all start up activities e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight. •Writes protocols and amendments in collaboration with study team members •Responsible for study specific feasibility and site selection to meet study enrollment and timelines. •Together with OPL and ECL/CPL responsible for developing the total external study budget and accountable for providing monthly and yearly estimates, tracking study budget, initiating payments, providing monthly information to controlling, OPL, ECL/CPL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues. •Tracks and compiles patient enrollment, data quality and cleaning progress and overall study progress and ensures study timelines are met •Responsible for training and oversight of CROs to ensure compliance with timelines and budget. •Develops appropriate study related training for monitors and site personnel according to GCP and company standards Qualifications Qualifications The qualified candidate is required to possess the following: •Bachelor's degree or equivalent education with 8+ years of relevant healthcare experience of which 5 years working in early clinical operations pharmaceutical (preferably oncology) including direct monitoring and clinical trial/study management experience. Ideal candidate will have solid clinical operations experience working as a study manager including 2 years of monitoring experience and a minimum of 3 years of study management (early oncology) experience is preferred •The incumbent is responsible for the direct management of Phase I & IIa complex oncology global clinical trials. This requires an in-depth knowledge of study management/project management. In addition Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations). The position also requires strong awareness and understanding of cultural differences as well as regional operational differences. •Demonstrated leadership in project management and vendor management. •The incumbent requires comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters. •Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, and excellent interpersonal, decision-making and issue resolution skills are required. In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through. Additional Information All your information will be kept confidential according to EEO guidelines.
    $78k-125k yearly est. 60d+ ago
  • Clinical Research Coordinator - Dutchess County, NY - Part-TIme

    Sitebridge Research, Inc.

    Clinical research coordinator job in Hyde Park, NY

    SiteBridge Description: Founded in 2021, SiteBridge Research is a community-focused integrated research organization, building a national network of community practices to deliver world-class industry sponsored clinical research on time and on budget, accelerating time to market and product adoption in communities that are the most vulnerable and the hardest to reach. The SiteBridge network extends reach further into these communities to empower a broader set of patients with some of the highest unmet needs to take part in clinical research to improve health outcomes. SiteBridge also helps with FDA diversity planning and building effective community engagement strategies. Job Description: Clinical Research Coordinator/Research Nurse - Contractor The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. In addition, and most importantly, this role represents our mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will be responsible for specific clinical site activities to maintain the operational excellence required of clinical sites/staff involved in clinical studies and to assure compliance with protocol-specific procedures, data acquisition, and records management. This role will report to the Director, Clinical Site Development Operations and Study Management. Location: The position is located in Hyde Park, NY and will be required to be on-site. Job Type: This is an (1099) Independent Contractor position and is part-time to begin with potential to move into full-time based on study needs. Responsibilities: Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines Ensure study feasibility assessments for contracted sponsor-initiated studies Assist the Clinical/Site Ops Leads on the set-up/start-up of research site to prepare for start-up and conduct of clinical trials Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO Consult with Site Leads, sponsor, and CRO to determine the best recruitment practices for site and trials Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies Arrange screening and recruitment of potential study participants by scheduling visits to establish Informed Consent and perform intake assessments according to protocols Create and maintain all essential documents and records related to the study Act as a point of reference for study participants by answering questions and keeping them informed on the study's progress Oversee and/or manage the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results Direct the request, collection, labeling, storage, or shipment of interventional products Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems Monitor the enrollment status of participants at the site for each specific clinical study Operate as primary contact for sponsors/CROs to schedule and coordinate site visits and answer queries Participate in meetings (Investigator Meetings, Site Trainings, etc.) and seminars to update knowledge of clinical research and related issues Prepare or participate in quality assurance audits and inspections performed by sponsors/CROs, regulatory authorities, or exclusively designated review groups Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops Leads on study progress related to recruitment, compliance, and other study-related matters Qualifications & Required Experience: Candidates with pediatric experience strongly encouraged to apply. Bachelor's degree in a relevant life science discipline is preferred; LPN/RN is preferred; certification as CCRC/CCRP is a plus; Education requirement exceptions can be made based on relevant clinical research experience Minimum 1 year of experience in clinical research. Number of years of previous experience working in a clinical research setting; number of years of clinical site/trials experience will determine position level Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required Strong preference for experience with late-phase and observational clinical research Managing necessary clinical study and staff records related to clinical study activities including: case report forms, drug dispensation records, etc. Preparing advertising and other educational materials and conducting campaigns to recruit and enroll subjects Preparing trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports Experience identifying, reviewing, and reporting adverse events, protocol deviations, or other unanticipated problems appropriately to investigators and/or regulatory agencies Assessing risk factors in study protocols such as sample collection procedures, data management issues, and possible subject threats Clinical and laboratory skills, including the ability to perform phlebotomy and process samples are preferred Detail-oriented and meticulous in all aspects of work Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative Superior organizational and time management skills Capable of working independently with minimal supervision and as part of a team Understanding of medical terminology as well as standard clinical procedures and protocol Ability to lift approximately 20 pounds for a short period and capable of standing for extended periods of time Additional Qualifications: Strong Project Management skills including risk assessment and contingency planning High level of collaboration, customer-oriented awareness, and focus Skilled with standard computer programs including the MS Office suite Strong interpersonal and written and verbal communication skills Therapeutic experience in alignment with primary protocol(s) and site practice preferred Some travel may be required Pay Range: The combined pay range for this role is $28 - $36/hour. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role. SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.
    $28-36 hourly 15d ago
  • Part-time Clinical On- Site Monitor

    Berkeley College 4.7company rating

    Clinical research coordinator job in Woodland Park, NJ

    Berkeley College, a career-focused institution of higher education, seeks a part-time Clinical On-Site monitor to observe and document the clinical procedures Surgical Technology and Surgical Processing Technician students perform in the clinical environment. This individual will also serve as the liaison between the clinical sites and the College. Primary Duties and Responsibilities Observe and document clinical procedures as performed in the clinical setting. Monitor case specialties of Surgical Technology students. Review clinical performance with each student. Review weekly student self-evaluations and skill assessments and advise as appropriate. Maintain clinical attendance logs. Serve as a liaison between the College and clinical affiliate staff. Meet with the Clinical Coordinator to discuss student performance. Occasional administrative work to be performed at the Woodland Park, NJ, campus upon request of the School Dean and/or Clinical Coordinator. Salary Range: $40-$45/hour Job Location The part-time staff position includes off-site visits to clinical sites as well as on-campus meetings and administrative work as requested by the School Dean and/or Allied Health Surgical Clinical Coordinator. Educational Requirements Be a graduate of an educational program in surgical technology accredited by a nationally recognized programmatic accreditation agency. Possess a credential in the field of surgical technology through a national certification program that is accredited by the National Commission on Certifying Agencies (NCCA). Training and/or Experience Have a minimum of three years of documented experience in the operating room scrub role or as an instructor in surgical technology, or a combination of both, within the past five years. Possession of a current unrestricted driver's license. Possess a current CST certification. Knowledge, Skills & Abilities Knowledgeable in the competencies required for competent Surgical Technologists and Surgical Processing Technicians. Knowledgeable about the program's evaluation of student learning and performance. Skilled in Microsoft Office applications such as Word and Excel. Knowledge of learning management systems is preferred. Miscellaneous Mileage, tolls, and parking will be paid to the part-time Clinical Site Monitor and will be based on the College's reimbursement policy. The maximum number of hours worked each week shall not exceed 20, unless prior approval is received. Berkeley College is an Equal Opportunity Employer and considers applicants for all positions regardless of race, color, religion, creed, gender, age, national origin, marital and veteran status, disability, sexual orientation, gender identity or expression, or any other legally protected status. We believe in fostering tolerance, acceptance, and understanding in our community, by employing individuals who bring unique perspectives to the College.
    $40-45 hourly 60d+ ago
  • Clinical Trials Coordinator

    St. Joseph's Health 4.8company rating

    Clinical research coordinator job in Paterson, NJ

    Under general supervision, coordinates clinical research protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality.t. Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Associates degree in Business, Public Health, or Health Education, and one to three years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred. Previous experience in clinical research or clinical trials coordination program management preferred.
    $47k-64k yearly est. Auto-Apply 2d ago
  • Clinical Trial Supply Manager

    Celldex Therapeutics 3.4company rating

    Clinical research coordinator job in Hampton, NJ

    The Clinical Supplies Trial Manager will support outsourcing of product manufacturing including labeling, packaging, and distribution of materials to clinical sites in the US and ROW. The key responsibilities that the Clinical Supplies Trial Manager will perform are managing Phase 2/3 clinical supplies and clinical distribution for global studies and investigating overseeing activities at commercial labeling / distribution contractors. Responsibilities * Manage the storage, distribution, and inventory tracking of bulk product, labeled product, co-medication inventory throughout the supply chain internally and at CMO's in the most cost-effective manner and in compliance with cGMP's. * Manage the day-to-day fulfillment of drug shipment requests for all products under clinical development in a cost effective and cGMP compliant manner. * Schedule and implement labeling, packaging, and quality release operations internally and with CMOs to ensure continuous clinical supply. * Responsible for receiving reports on excursions or deviations that may occur during shipment, handling, and storage of drug products. Drive such investigations to resolution in collaboration with Quality, CMO and clinical sites and define and implement procedures to minimize future occurrences. * Implement tracking systems to document the genealogy and detailed lot usage history of all drugs for each clinical trial. * Working internally and with CMOs, manage the distribution and global depot locations with special considerations on import licenses and shipping lead times for country specific requirements. * Arrange for cost effective return/destruction of all products no longer suitable for clinical use. * Meet financial objectives by forecasting budget requirements; preparing project budgets; reviewing CMO proposals, issuing and scheduling expenditures; analyzing change in scope and reviewing invoices for accuracy. * Schedule and implement labeling, packaging, and quality release operations with CMOs to ensure continuous clinical supply. * Work with CMOs, to manage the distribution and global depot locations with special considerations on import licenses and shipping lead times for country specific requirements. * Meet financial objectives by forecasting budget requirements; preparing project budgets; reviewing CMO proposals, issuing and scheduling expenditures; analyzing change in scope and reviewing invoices for accuracy. Qualifications * BA/BS degree, or equivalent work experience * 5+ years' experience working in a Manufacturing or Pharmaceutical Environment, at least two to three years of which directly involve Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in a Biotech, Pharmaceutical, or CRO company * Involvement in labeling, packaging and distribution is preferred * Experience managing internal resources and external contractors/vendors * Demonstrated success in delivering projects on time with team satisfaction * Experienced in meeting facilitation * Ability to travel up to 10-20% * Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors * Strong medical writing skills, takes ownership of document, organizes timeline, works with other co-authors, resolves discrepancies and edits to achieve consistency, and uses precise accurate language and grammar * Knowledge and experience in clinical development * Strong working knowledge of IRT systems such as, Signant and Suvoda. * Ability to multitask to meet timelines under changing conditions * Excellent analytical and organizational skills * Strong written/verbal communication skills * The ability to work independently and as part of a team * Team player with demonstrated ability to prospectively identify issues and to influence key project decisions to achieve positive outcomes * Proficiency in MS Office software such as Project, Word, Excel, Outlook, Visio, and PowerPoint Compensation:The expected base salary range for this position is $116,156 - $150,852 . We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page. Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach
    $116.2k-150.9k yearly Auto-Apply 3d ago
  • Clinical Study Associate Manager (CSAM)

    Regeneron Pharmaceuticals 4.9company rating

    Clinical research coordinator job in Armonk, NY

    The Associate Manager Clinical Study (CSAM) role supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct execution versus oversight of CROs deliverables will vary accordingly. The Assoc Mgr Clinical Study works with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Regeneron Standard Operating Procedures (SOPs). Travel to study sites may be required to assist with monitoring clinical studies. A typical day in this role looks like: * May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study * Contributes to risk assessment and helps identify risk mitigation strategies * Supports feasibility assessment to select relevant regions and countries * Oversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc. * Reviews site level informed consents and other patient-facing study start-up materials * Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of required vendors for the study * Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation * Provides regular status reports to stakeholders as requested by the Clinical Study Lead * Contributes to development of and oversees implementation of recruitment and retention strategies * Monitors recruitment and retention * Monitors progress for site activation and monitoring visits * Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites * Escalates data flow and data quality issues to Clinical Study Lead * Oversees the execution of the specific clinical study deliverables against planned timelines * Escalates issues related to timelines or budget to Clinical Study Lead * Supports accurate budget management and scope changes * Contributes to clinical project audit and inspection readiness throughout the study lifecycle * Supports internal and external inspection activities and contributes to CAPAs as required * Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability * May be responsible for mentoring clinical trial management staff * May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring In order to be considered qualified for this role, a minimum of Bachelor's degree and 4+ years of relevant clinical trial expereince is required. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $109,900.00 - $179,300.00
    $109.9k-179.3k yearly Auto-Apply 3d ago
  • Clinical: CF - North Haledon- PDN

    Modivcare

    Clinical research coordinator job in North Haledon, NJ

    Apply today and become a valuable member of our Modivcare PDN Family! Care Finders Total Care, a Modivcare Personal Care Service, is looking for an RN or LPN responsible for providing high-quality services to our home care private duty clients. Position Spotlight... Pay: LPN hourly rate $35 , RN hourly rate $40 Schedule: 2 days per week Mon & Tues 7:30a-5p Area of Coverage: North, Central, South New Jersey Full Time Benefits Package if eligible: See below more details. You will... Conduct initial home visits to assess patient needs. Provide skilled nursing care following Patients Physicians Orders, Medication profile/sheet. Document daily clinical notes and progress updates on the patient's clinical record Communicate with a patient's physician and other healthcare professionals to ensure delivery of appropriate patient care. We are excited to speak to someone with the following… RN or LPN with at least 1 year of experience preferred. Experience in Home Healthcare preferred. Strong clinical judgment and critical thinking skills to make effective decisions with ability to adhere to Company/State/Regulatory requirements· We value our team members and realize the importance of benefits for you and your family. Modivcare offers Full Time or variable hour employees working an averaged 30 hours per week a comprehensive benefits package including the following: Medical, Dental & Vision Insurance 401(k) with a 6% match Paid Time Off Employee Assistance Program Employee Discounts (retail, hotel, food, restaurants, car rental, and much more!) Voluntary Term Life and AD&D Insurance Legal Services Insurance Short-Term and Long-Term Disability Accident, Critical Illness & Hospital Indemnity Insurance We live and lead by our Values… • We treat everyone with dignity and RESPECT • We earn the TRUST of our members, and each other • We provide RELIABLE services that open doors • We serve with courtesy and COMPASSION • We prioritize SAFETY • We communicate with purpose and TRANSPARENCY Modivcare. Because we care...always. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
    $35-40 hourly 60d+ ago

Learn more about clinical research coordinator jobs

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

The average clinical research coordinator in Goshen, 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 Goshen, NY

$60,000
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