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Clinical Research Coordinator jobs at Memorial Sloan Kettering Cancer Center - 146 jobs

  • Clinical Trial Operations, Senior Clinical Trial Associate/Clinical Trial Associate

    Anavex 2.8company rating

    New York, NY jobs

    Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Trial Associates (CTA). This role will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents, assisting with study start-up, conduct and close-out of study activities. This individual will have accountability for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF). Key Responsibilities * Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation. * Set up and maintain study-specific paper and electronic TMFs. * Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices. * Track and report CRO's ability to maintain TMF health metrics on an ongoing basis. * Process essential documents and ensure they are correctly filed in the appropriate TMF. * Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed. * Participate in GxP audits and related clinical operations compliance and inspection readiness activities. * Prepare and track study documents (e.g., contracts, budgets, IRB documentation). * Assist with information gathering, literature searches, and creation of presentations, as needed. * Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.) * Administer user access and change control within Anavex's electronic systems. * Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems. * Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards. * Assist with vendor management and associated logistics, as assigned. * Contribute to the creation of presentations, as needed for project, departmental, sponsor, and/or business development presentations. * Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies. * Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel) * Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual. * Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management. * Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF. * Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information. * Assist in creating and implementing departmental SOPs and procedures. The position will be filled at a level commensurate with experience. Requirements * BS/BA in Life Sciences or equivalent * 3+ years of experience in similar positions in Biotech, Pharmaceutical, or clinical research organization environment * Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC/ QR, and query management. * Familiar with the DIA reference model * Knowledge of ICH/GCP and applicable regulations * Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence the decision-making of managers, and working partners (local and global) * Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining a high attention to detail and responding to rapidly changing priorities and aggressive deadlines * Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox * Strong critical thinking, organizational and time-management skills * Ability and willingness to travel (up to 10% of the time)
    $79k-131k yearly est. 2d ago
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  • Clinical Trial Operations, Senior Clinical Trial Associate/Clinical Trial Associate

    Anavex Life Sciences Corp 2.8company rating

    New York, NY jobs

    If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research and development, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs, as well as for our partners across major therapeutic areas. Senior Clinical Trial Associate/Clinical Trial Associate Apply Summary of Position Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Trial Associates (CTA). This role will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents, assisting with study start-up, conduct and close-out of study activities. This individual will have accountability for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF). Key Responsibilities Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation. Set up and maintain study-specific paper and electronic TMFs. Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices. Track and report CRO's ability to maintain TMF health metrics on an ongoing basis. Process essential documents and ensure they are correctly filed in the appropriate TMF. Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed. Participate in GxP audits and related clinical operations compliance and inspection readiness activities. Prepare and track study documents (e.g., contracts, budgets, IRB documentation). Assist with information gathering, literature searches, and creation of presentations, as needed. Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.) Administer user access and change control within Anavex's electronic systems. Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems. Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards. Assist with vendor management and associated logistics, as assigned. Contribute to the creation of presentations, as needed for project, departmental, sponsor, and/or business development presentations. Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies. Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel) Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual. Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management. Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF. Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information. Assist in creating and implementing departmental SOPs and procedures. The position will be filled at a level commensurate with experience. Requirements BS/BA in Life Sciences or equivalent 3+ years of experience in similar positions in Biotech, Pharmaceutical, or clinical research organization environment Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC/ QR, and query management. Familiar with the DIA reference model Knowledge of ICH/GCP and applicable regulations Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence the decision-making of managers, and working partners (local and global) Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining a high attention to detail and responding to rapidly changing priorities and aggressive deadlines Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox Strong critical thinking, organizational and time-management skills Ability and willingness to travel (up to 10% of the time) Your Path to Unique Opportunities If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) diseases, pain, and various types of cancer. Further information is available at ************** . EOE/M/F/V/SO Anavex Life Sciences Corp. is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status. Visit anavex.com/eeo-policy-statement to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Stay Connected Follow us on social media Letter from the CEO Our Values Contact Us
    $79k-131k yearly est. 2d ago
  • Research Coordinator

    Regional Cancer Care Associates 4.2company rating

    Sparta, NJ jobs

    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
  • Clinic Trials Support Specialist

    Maimonides Medical Center 4.7company rating

    New York, NY jobs

    About Us We're Maimonides Health, Brooklyn's largest healthcare system, serving over 250,000 patients each year through the system's 3 hospitals, 1800 physicians and healthcare professionals, more than 80 community-based practices and outpatient centers. At Maimonides Health, our core values H.E.A.R.T drives everything we do. We uphold and maintain Honesty, Empathy, Accountability, Respect, and Teamwork to empower our talented team, engage our respective communities and adhere to Planetree's philosophy of patient-centered care. The system is anchored by Maimonides Medical Center, one of the nation's largest independent teaching hospitals and home to centers of excellence in numerous specialties; Maimonides Midwood Community Hospital (formerly New York Community Hospital), a 130-bed adult medical-surgical hospital; and Maimonides Children's Hospital, Brooklyn's only children's hospital and only pediatric trauma center. Maimonides' clincal progams rank among the best in the country for patient outcomes, including its Heart and Vascular Institute, Neuroscience Institute, Boneand Joint Center, and Cancer Center. Maimonides is an affiliate of Northwell Health and a major clinical training site for SUNY Downstate College of Medicine. Overview The Clinic Trials Support Specialist responsible for coordinating and supporting the conduct of clinical research protocols and projects, with a primary focus on screening, enrolling, and monitoring patient participants. This role works closely with investigators, clinical teams, and research staff to ensure studies are conducted in accordance with approved protocols, regulatory requirements, and institutional policies while maintaining participant safety and data integrity. Responsibilities * Prepare, submit, and maintain IRB and regulatory documentation, including Trial Master File, delegation logs, regulatory binders, and essential study files * Screen, enroll, and consent participants in collaboration with the Principal Investigator, ensuring proper informed consent documentation * Educate study participants on protocol requirements and support completion of required study procedures and surveys * Coordinate participant visits, tests, and procedures; assist physicians during patient visits in accordance with study protocols * Monitor subject recruitment and study progress, report adverse events in RAVE following discussion with the Principal Investigator * Collect, process, and ship research specimens per protocol and IATA/DOT standards; manage study kit inventory, shipments, and data collection from electronic medical records, including timely database submission and query resolution Qualifications We require: * Bachelors of Science in Biology or Chemistry; Masters preferred. * 2+ years of research experience in the medical field or an advanced degree in a Biology or Chemistry required. * Good oral and written communication skills. * Good interpersonal and organizational skills. * Speaks, reads and writes English to the extent required by the position. * Ability to speak Chinese or Mandarin is a plus. Pay Range USD $66,779.00 - USD $66,779.00 /Yr. Equal Employment Opportunity Employer Maimonides Medical Center (MMC) is an equal opportunity employer.
    $66.8k yearly 9d ago
  • Clinical Trials Coordinator II

    St. Joseph's Healthcare System 4.8company rating

    New Jersey jobs

    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. Navigate patients through clinical trials. Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Bachelors degree in Business, public health , or healthcare administration or closely related field, and two to four years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred.
    $50k-67k yearly est. Auto-Apply 2d ago
  • Hand & Upper Extremity Research Coordinator

    Hospital for Special Surgery 4.2company rating

    New York, NY jobs

    How you move is why we're here. Now more than ever. Get back to what you need and love to do. The possibilities are endless... Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize the abundant opportunities for growth and success. If this describes you then let's talk! HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment. Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise. Emp Status Regular Full time Work Shift Compensation Range The base pay scale for this position is $56,000.00 - $85,250.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.What you will be doing While the Research Coordinator is expected to contribute to and coordinate research activities and projects in many ways, typical responsibilities include the following: Develops and implements recruitment strategies to meet patient enrollment targets. Coordinates projects and assignments for Hand & Upper Extremity Research Assistant. Screens and enrolls patients in research studies following inclusion/exclusion criteria. Oversees and conducts the informed consent process (requires certification of human research subjects training). Schedules and coordinates patient visits and follow-ups within protocol-specified timeframes and ensures all assessments and procedures are performed per protocol. Manages data collection specific to research studies and performance of duties as per HUE research protocol. Collaborates with multidisciplinary teams involved in the successful initiation and conduct of clinical research studies and clinical trials (such as, research administration, legal, finance, compliance, etc.) Performs advanced data queries as needed and provides timely reports to all required stakeholders. Prepares literature reviews for IRB submissions, research protocols, and research grants. Helps prepare research grant applications by developing research protocols, study budgets, etc. Manages and executes IRB submissions and ensures no lapses in approvals. Collaborates with Principal Investigators, research administration, and all necessary departments to ensure compliance with all federal regulations and sponsoring agency policies and procedures. Develops new protocols, databases, and tools for specific projects. Complies with all regulatory, institutional, and departmental requirements, maintains regulatory binders, and prepares documents for the FDA. Participates in all aspects of research management and quality assurance for the Principal Investigators. Ensures adherence to standards for subject registration, protocol tests, and documentation in collaboration with the research team and research administration. Reports deviations and resolves issues, escalating appropriately when necessary. Assists in collecting, transporting, processing, and storing biospecimens as indicated by research protocols. Assists in the onboarding and training of new research assistants and fellows as needed, ensuring they understand all research protocols and regulatory requirements. Collaborates with Chief & Research Director of Hand & Upper Extremity Service to coordinate and facilitate research meetings, including preparing study and registry updates. Publishing & Editing Responsibilities: Manages the submission and review process of journal submissions under the guidance of the Chief & Research Director of the Hand & Upper Extremity Service. Assists with formatting manuscripts for journal submission. Ensures adherence to established turnaround times by following up with authors, reviewers, or editors and send/set up reminders as appropriate. Reviews manuscripts for adherence to journal guidelines and standards. Invites, tracks, and follows-up with authors for revisions or solicited content. Handles day-to-day communications with editors, authors, and reviewers. Responds to all emails or phone calls in a timely and professional manner. Coordinates and troubleshoots author submissions, ensuring author submissions are complete and meet all journal requirements, including the required ancillary materials such as copyright forms, disclosures/COIs details, permissions, figure files, etc. Provides timely follow up on any missing materials to ensure they are collected with submission. Ensures compliance with ethical standards and copyright regulations in all journal-related activities. Job Requirements Education / Training / Experience: Bachelor's degree, Masters preferred. ACRP, SOCRA, or similar certification preferred. 3-5 years of clinical research experience Statistical analysis experience preferred. Familiarity with data capture platforms such as REDCap and EMRs (Epic) preferred. Skills: Proficiency in Microsoft Excel, Outlook, PowerPoint, and Word Excellent verbal and written communication skills Excellent organizational, problem-solving, customer service, and interpersonal skills Ability to multitask. Knowledge of Good Clinical Practice for the handling of specimens and blood Knowledge of Human Subjects research regulations and HIPAA compliance Knowledge of FDA regulations for clinical trials Knowledge of Orthopedic terminology is preferred. Non-Discrimination Policy Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.
    $56k-85.3k yearly Auto-Apply 19d ago
  • Research Coordinator

    Hospital for Special Surgery 4.2company rating

    New York, NY jobs

    How you move is why we're here. Now more than ever. Get back to what you need and love to do. The possibilities are endless... Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize the abundant opportunities for growth and success. If this describes you then let's talk! HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment. Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise. Emp Status Regular Full time Work Shift Day (United States of America) Compensation Range The base pay scale for this position is $56,000.00 - $85,250.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future. What you will be doing Responsibilities include, but are not limited to: * Contribute to the submission and management (e.g., amendments and continuing reviews) of IRB protocols. * Integrate study protocol requirements, working with Dr. Otero and different study members or study PIs to coordinate clinical research administration, legal, finance, compliance, and laboratory efforts. * Contribute to and manage regulatory and patient-facing aspects of clinical studies, including patient screening, enrollment and consent, biospecimen retrieval and transport, and clinical data management. * Oversee, conduct and manage the informed consent process. * Coordinate patient research visits, including follow up visits, ensuring adherence to study protocols. * Ensure compliance with all regulatory requirements, including but not only maintenance of regulatory binders for studies directly led by Dr. Otero and the RC. * Collect and manage clinical data, ensuring compliance with regulatory aspects and patient privacy. * Securely access and use EMR systems (e.g., EPIC) and databases (e.g., REDCap). * Provide training, oversight and consultation to study team members on all study aspects, coordinating with Dr. Otero and specific study PIs (as needed) for IRB submission, patient screening and consent, maintenance of regulatory binders, and biospecimen handling and transportation. * Conduct literature searches and perform data analyses, in collaboration with the study team and the Department of Biostatistics and Bioinformatics. * Carry out clerical and technical tasks, including maintaining secure databases. * Liaise with investigators and Hospital staff, including phone calls, email communications, or videoconferencing. * Take an active role in data interpretation, generation of reports, presentations, and manuscripts * Participate in laboratory and departmental meetings Minimum job requirements: * Bachelor's degree in life sciences or equivalent. * Experience with clinical research. * Technical proficiency and ability to work both independently and as part of a team. * Ability to learn new tasks following detailed protocols and instructions. * Excellent time management and organizational skills. * Proficient use of computers and software. * Experience managing confidential information. * Preferred commitment, 2+ years. Non-Discrimination Policy Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.
    $56k-85.3k yearly Auto-Apply 44d ago
  • Research Coordinator

    Hospital for Special Surgery 4.2company rating

    New York, NY jobs

    How you move is why we're here. Now more than ever. Get back to what you need and love to do. The possibilities are endless... Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize the abundant opportunities for growth and success. If this describes you then let's talk! HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment. Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise. Emp Status Regular Full time Work Shift Day (United States of America) Compensation Range The base pay scale for this position is $54,000.00 - $82,125.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.What you will be doing Reports to: Director of Clinical Research for the Complex Joint Reconstruction Center The following statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. SUMMARY: This individual will be an integral member of the research team in compliance with all regulatory, institutional, and departmental requirements. The candidate will participate in all aspects of research management and quality assurance of data for the projects that will come out of The Complex Joint Reconstruction Center. The candidate will play an integral role in day-to-day research activities and patient coordination ensuring efficient operations. RESPONSIBILITIES: Research/Registry: Coordinates the synchronization of research activities within CJRC under the direction of the Director of Clinical Research and serves as a liaison between the clinicians, research staff, and other research assistants. Provide overall administrative support for registry/clinical research activities. Provides timely reports to Director, Institutional Review Board, Principal Investigator, National Institutes of Health and/or sponsor for each research project. Contributes to all aspects of CJRC research: -Protocol development -Recruitment process (conducts informed consent process) -The development and build of Clinical Research Forms and standard operating procedures as needed by study protocol -Assures that research is done in an accurate and efficient manner. Ensures that all research related regulatory, institutional, and departmental compliance requirements are met as appropriate. Handles I.T. communications (requests) and generates reports from the registry as needed. Facilitates completion of all internal documentation needed for research (IRB applications, conflict of interest forms, data collection forms, etc.) Assists in data collection for registry/research-specific studies including but not limited to the performance of measurements for applicable studies, collection of clinical data from patients directly, and manage the performance of all other duties as put forth in the protocol. Assists in patient care coordination by assuring patients complete CJRC forms and patient reported outcomes prior to office visits Responsibilities associated with specific studies include but are not limited to; creation and update of enrollment/screening logs, drug tracking and dispensing, patient contact, administrative support (meetings/minutes/data entry), communication with multidisciplinary study staff, and support for Research Assistants (level 1) Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of research data management. MINIMUM JOB REQUIREMENTS: Education/Training: Bachelor's degree required, Masters preferred Experience: 2+ years of experience in clinical research required Prior Epic experience Knowledge of Good Clinical Practice and Good Technology Practice Proficient use of computers and software Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus. EDUCATION REQUIRED Bachelors EDUCATION PREFERRED CERTIFICATIONS/LICENSURE REQUIRED CERTIFICATIONS/LICENSURE PREFERRED SKILLS REQUIRED SKILLS PREFERRED Knowledge of Orthopedic and/or Rheumatologic terminology is a plus. Non-Discrimination Policy Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.
    $54k-82.1k yearly Auto-Apply 60d+ ago
  • Clinical Trials Coordinator

    St. Joseph's Healthcare System 4.8company rating

    Paterson, NJ jobs

    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. St. Joseph's Health is recognized for the expertise and compassion of its highly skilled and responsive staff. The combined efforts of the organization's outstanding physicians, superb nurses, and dedicated clinical and professional staff have made us one of the most highly respected healthcare organizations in the state, the largest employer in Passaic County, and one of the nation's "100 Best Places to Work in Health Care".
    $50k-67k yearly est. Auto-Apply 60d+ ago
  • Clinical Trials Coordinator

    St. Joseph's Healthcare System 4.8company rating

    Paterson, NJ jobs

    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 6d ago
  • Clinical Trials Coordinator II

    St. Joseph's Health 4.8company rating

    New Jersey jobs

    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. Navigate patients through clinical trials. Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Bachelors degree in Business, public health , or healthcare administration or closely related field, and two to four years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred.
    $47k-64k yearly est. Auto-Apply 2d ago
  • Research Coordinator - Per Diem

    Albany Med 4.4company rating

    New Scotland, NY jobs

    Department/Unit: Emergency Medicine General Work Shift: Per Diem (United States of America) Salary Range: $51,755.37 - $77,633.06The clinical research coordinator is responsible for the organization and management of multiple industry sponsored and investigator initiated clinical trials. The position is accountable for assisting in the timely and accurate conduct of research studies. Activities include participating in the study start up and termination procedures, working with study participants in various study tasks including patient recruitment, screening as well as data collection and study completion activities. The research coordinator is the liaison between PI and research site and the study sponsor. Thank you for your interest in Albany Medical Center! Albany Medical is an equal opportunity employer. This role may require access to information considered sensitive to Albany Medical Center, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that: Access to information is based on a “need to know” and is the minimum necessary to properly perform assigned duties. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. Reasonable efforts, consistent with Albany Med Center policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.
    $51.8k-77.6k yearly Auto-Apply 15d ago
  • Research Coordinator

    Regional Cancer Care Associates 4.2company rating

    Freehold, NJ jobs

    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: Freehold, 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
  • Research Coordinator - Per Diem

    Albany Medical Health System 4.4company rating

    Albany, NY jobs

    Department/Unit: Emergency Medicine General Work Shift: Per Diem (United States of America) Salary Range: $51,755.37 - $77,633.06 The clinical research coordinator is responsible for the organization and management of multiple industry sponsored and investigator initiated clinical trials. The position is accountable for assisting in the timely and accurate conduct of research studies. Activities include participating in the study start up and termination procedures, working with study participants in various study tasks including patient recruitment, screening as well as data collection and study completion activities. The research coordinator is the liaison between PI and research site and the study sponsor. Thank you for your interest in Albany Medical Center! Albany Medical is an equal opportunity employer. This role may require access to information considered sensitive to Albany Medical Center, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that: Access to information is based on a "need to know" and is the minimum necessary to properly perform assigned duties. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. Reasonable efforts, consistent with Albany Med Center policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.
    $51.8k-77.6k yearly Auto-Apply 13d ago
  • Clinical Trials Coordinator

    St. Joseph's Health 4.8company rating

    Paterson, NJ jobs

    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 6d ago
  • Research Coordinator

    Regional Cancer Care Associates 4.2company rating

    Howell, NJ jobs

    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: Howell, 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 Coordinator

    Astera Cancer Care 4.0company rating

    East Brunswick, NJ jobs

    Why Join Us? For us, what matters most is excellence. We are caring professionals, people who live, work and dedicate themselves to the communities within New Jersey and Pennsylvania. As such, we strive to provide a sanctuary of excellence, precision, thoroughness and genuine compassion. We also take a whole-person approach to patient care and treatment, tailoring all that we do around their unique needs. And we do all we can for patients, going the extra mile to see that they're supported, informed and getting the one-on-one care and service they deserve. Job Description: As an Oncology Clinical Research Coordinator (CRC), you will be an integral part of studies at Astera Cancer Care by recruiting participants, collecting and managing the study data for the successful management of clinical trials. This is a full-time position. Responsibilities Include: Provide overall coordination of study-related activities for patients enrolled in cancer research studies through the Astera research program. Coordinate with Principal Investigators, Supervisor and study sponsors and CROs to ensure that clinical research activities are performed in accordance with local and federal regulations and adhere to policies and procedures of Astera and the sponsors and CROs. Assist in the coordination of tests and visits for patients and collaborate with the Astera study team to maximize work efficiency and productivity. Assist in IRB submissions and interact with the Supervisor to maintain regulatory documents and administrative files for each protocol. Work with research nurses, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials. Maintain patient and regulatory research records. Confer with all members of the clinical team to confirm appropriateness and timeliness of tests. Collect follow-up data on patient's post-treatment as required by the protocol. Submit weekly reports to Supervisor, tracking patient screening/enrollment and subject status. Enter research data into a centralized database as per protocol requirements. Attend investigator meetings as required or requested by the Principal Investigator. Prepare other study materials as requested by the Principal Investigator such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs. If applicable, able to prepare blinded and unblinded study drugs. If applicable, act as primary coordinators for unblinded team. Qualifications: A Bachelor's degree or equivalent working experience required. Pharmacy Technician certified with infusion drug preparation training preferred. At least one (1) year of clinical research experience, Oncology experience a plus. Experience in Oncology Patient Recruitment and retention skills. Experience with EDC, IWRS. CRF and Microsoft applications. Able to travel between offices within the offices in Northeast Jersey area. Excellent communication skills. Excellent time management skills.
    $52k-75k yearly est. Auto-Apply 46d ago
  • Clinical Research Coordinator

    Hackensack University Medical Center 4.5company rating

    Neptune, NJ jobs

    Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change. The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which is assigned. Responsibilities A day in the life of a Clinical Research Coordinator at Hackensack Meridian Health includes: * Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol. * In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study. * Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator. * Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversee subject enrollment to ensure that informed consent is properly obtained and documented. * Coordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams as required. * Works with the study team to draft/create study specific study orders, billing templates and study calendars as necessary. * Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols. * Monitors all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies. * Registers protocol patients with appropriate statistical centers as required. * Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts. * Acts as principal investigator`s representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnel. * Along with clinical research nurses, maintains accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required. * Works closely with clinical research finance to ensure study patient`s clinical trial related activities are billed appropriately. * Schedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit. * Maintains contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data. * Ensures compliant maintenance of all required records of study activity including case report forms, drug dispensation records, or regulatory forms. * Oversees and directs the requisition, collection, labeling, storage, or shipment of specimens. * Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. * Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. * Identifies protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions. * Organizes space for study equipment and supplies. * Participates in the development of study protocols including guidelines for administration or data collection procedures * Contacts outside health care providers and communicate with subjects to obtain follow-up information. * Reviews scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues. * Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. * Attends research meetings and conferences as required. * Participates in staff meetings and in-service education as necessary. * Other duties and/or projects as assigned. * Adheres to HMH Organizational competencies and standard of behavior. Qualifications Education, Knowledge, Skills and Abilities Required: * BA/BS diploma/degree in science or healthcare field. * Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research. * Strong attention to detail and customer service focus. * Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential. * Excellent organizational, presentation, documentation and interpersonal skills. * Excellent written and verbal communication skills. * Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms. Education, Knowledge, Skills and Abilities Preferred: * Education on human subject research and GCP. Licenses and Certifications Preferred: * SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC). If you feel that the above description speaks directly to your strengths and capabilities, then please apply today! Compensation Minimum rate of $78,395.20 Annually HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to: * Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. * Experience: Years of relevant work experience. * Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training. * Skills: Demonstrated proficiency in relevant skills and competencies. * Geographic Location: Cost of living and market rates for the specific location. * Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization. * Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits. HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran. Our Network Hackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience. Apply Save Job saved
    $78.4k yearly Auto-Apply 9d ago
  • Research Coordinator

    Hospital for Special Surgery 4.2company rating

    Day, NY jobs

    How you move is why we're here. Now more than ever. Get back to what you need and love to do. The possibilities are endless... Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize the abundant opportunities for growth and success. If this describes you then let's talk! HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment. Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise. Emp Status Regular Full time Work Shift Day (United States of America) Compensation Range The base pay scale for this position is $56,000.00 - $85,250.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.What you will be doing Responsibilities include, but are not limited to: Contribute to the submission and management (e.g., amendments and continuing reviews) of IRB protocols. Integrate study protocol requirements, working with Dr. Otero and different study members or study PIs to coordinate clinical research administration, legal, finance, compliance, and laboratory efforts. Contribute to and manage regulatory and patient-facing aspects of clinical studies, including patient screening, enrollment and consent, biospecimen retrieval and transport, and clinical data management. Oversee, conduct and manage the informed consent process. Coordinate patient research visits, including follow up visits, ensuring adherence to study protocols. Ensure compliance with all regulatory requirements, including but not only maintenance of regulatory binders for studies directly led by Dr. Otero and the RC. Collect and manage clinical data, ensuring compliance with regulatory aspects and patient privacy. Securely access and use EMR systems (e.g., EPIC) and databases (e.g., REDCap). Provide training, oversight and consultation to study team members on all study aspects, coordinating with Dr. Otero and specific study PIs (as needed) for IRB submission, patient screening and consent, maintenance of regulatory binders, and biospecimen handling and transportation. Conduct literature searches and perform data analyses, in collaboration with the study team and the Department of Biostatistics and Bioinformatics. Carry out clerical and technical tasks, including maintaining secure databases. Liaise with investigators and Hospital staff, including phone calls, email communications, or videoconferencing. Take an active role in data interpretation, generation of reports, presentations, and manuscripts Participate in laboratory and departmental meetings Minimum job requirements: Bachelor's degree in life sciences or equivalent. Experience with clinical research. Technical proficiency and ability to work both independently and as part of a team. Ability to learn new tasks following detailed protocols and instructions. Excellent time management and organizational skills. Proficient use of computers and software. Experience managing confidential information. Preferred commitment, 2+ years. Non-Discrimination Policy Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.
    $56k-85.3k yearly Auto-Apply 45d ago
  • Research Coordinator

    Hospital for Special Surgery 4.2company rating

    Day, NY jobs

    How you move is why we're here. Now more than ever. Get back to what you need and love to do. The possibilities are endless... Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize the abundant opportunities for growth and success. If this describes you then let's talk! HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment. Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise. Emp Status Regular Full time Work Shift Day (United States of America) Compensation Range The base pay scale for this position is $54,000.00 - $82,125.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.What you will be doing Reports to: Director of Clinical Research for the Complex Joint Reconstruction Center The following statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. SUMMARY: This individual will be an integral member of the research team in compliance with all regulatory, institutional, and departmental requirements. The candidate will participate in all aspects of research management and quality assurance of data for the projects that will come out of The Complex Joint Reconstruction Center. The candidate will play an integral role in day-to-day research activities and patient coordination ensuring efficient operations. RESPONSIBILITIES: Research/Registry: Coordinates the synchronization of research activities within CJRC under the direction of the Director of Clinical Research and serves as a liaison between the clinicians, research staff, and other research assistants. Provide overall administrative support for registry/clinical research activities. Provides timely reports to Director, Institutional Review Board, Principal Investigator, National Institutes of Health and/or sponsor for each research project. Contributes to all aspects of CJRC research: -Protocol development -Recruitment process (conducts informed consent process) -The development and build of Clinical Research Forms and standard operating procedures as needed by study protocol -Assures that research is done in an accurate and efficient manner. Ensures that all research related regulatory, institutional, and departmental compliance requirements are met as appropriate. Handles I.T. communications (requests) and generates reports from the registry as needed. Facilitates completion of all internal documentation needed for research (IRB applications, conflict of interest forms, data collection forms, etc.) Assists in data collection for registry/research-specific studies including but not limited to the performance of measurements for applicable studies, collection of clinical data from patients directly, and manage the performance of all other duties as put forth in the protocol. Assists in patient care coordination by assuring patients complete CJRC forms and patient reported outcomes prior to office visits Responsibilities associated with specific studies include but are not limited to; creation and update of enrollment/screening logs, drug tracking and dispensing, patient contact, administrative support (meetings/minutes/data entry), communication with multidisciplinary study staff, and support for Research Assistants (level 1) Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of research data management. MINIMUM JOB REQUIREMENTS: Education/Training: Bachelor's degree required, Masters preferred Experience: 2+ years of experience in clinical research required Prior Epic experience Knowledge of Good Clinical Practice and Good Technology Practice Proficient use of computers and software Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus. EDUCATION REQUIRED Bachelors EDUCATION PREFERRED CERTIFICATIONS/LICENSURE REQUIRED CERTIFICATIONS/LICENSURE PREFERRED SKILLS REQUIRED SKILLS PREFERRED Knowledge of Orthopedic and/or Rheumatologic terminology is a plus. Non-Discrimination Policy Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.
    $54k-82.1k yearly Auto-Apply 60d+ ago

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