Clinical Research Coordinator jobs at Memorial Sloan Kettering Cancer Center - 153 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)

About the Job Job Title: Certified Clinical Research Coordinator (CCRC) Part-Time | One Day per Week (On-Site) 222 East 31st street, second floor, New. York, NY 10016 We are seeking a Certified Clinical Research Coordinator (CCRC) to join our growing clinical research site on a part-time basis (one day per week). This role is ideal for an experienced coordinator who values high-quality research, operational excellence, and schedule flexibility. The CCRC will play a critical role in ensuring the ethical, regulatory, and operational integrity of clinical trials while supporting investigators, participants, and sponsors in a highly organized and patient-centered environment. Key Responsibilities: Coordinate and manage assigned clinical trials in compliance with GCP, ICH, FDA regulations, and IRB requirements. Serve as the primary point of contact for study participants, investigators, sponsors, and CROs on assigned study days. Conduct study visits, including participant screening, informed consent, visit coordination, and protocol-specified procedures. Ensure accurate, timely, and complete documentation in source documents, EDC systems, and regulatory binders. Support monitoring visits, audits, and inspections, ensuring readiness and responsiveness. Maintain study supplies, investigational product accountability, and specimen handling per protocol. Collaborate closely with the Principal Investigator and research leadership to support study success. Qualifications: Certified Clinical Research Coordinator (CCRC) required. Minimum 2+ years of hands-on clinical research coordination experience. Strong working knowledge of GCP, ICH, FDA regulations, and IRB processes. Experience working directly with sponsors, CROs, and monitors. Excellent organizational skills with high attention to detail. Professional, patient-centered communication style. Ability to work independently and efficiently in a focused, one-day-per-week role. Preferred Experience: Experience in industry-sponsored clinical trials. Familiarity with EDC platforms (e.g., Medidata, REDCap, Veeva, or similar). Experience across multiple therapeutic areas (not required). Schedule & Commitment: One consistent day per week (on-site). Ideal for professionals seeking: Supplemental income. Portfolio or semi-retired work. Balance alongside another research or clinical role. What We Offer: Competitive hourly compensation commensurate with experience. A highly organized, collaborative, and respectful research environment. The opportunity to contribute meaningfully to clinical research without a full-time commitment. Stable, predictable schedule with minimal administrative burden. How to Apply Please submit your CV and a brief cover note highlighting your clinical research experience and availability. AboutBethany Medical Clinic About Bethany Medical Clinic of New York:At Bethany Medical Clinic, we value our patients' time and busy schedules. That is why we offer early morning and after work hour appointments at our conveniently located Murray Hill office in New York City. Our goal is to keep waiting time to a minimum and maximize our high level of expertise in an efficient manner during your appointment. You can expect a personalized, non-corporate approach and compassionate care. We embrace the contemporary philosophy that primary care should be predictive, rather than reactive. We not only listen to our patients, but we help them shape their own healthcare journey. Visit our website at *************** for more information!

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

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.

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.

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.

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.

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.

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".

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

Under general supervision, coordinates clinical research protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality. 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.

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.

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

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.

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.

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

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.

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.

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: Coordinates clinical research activities for the ARJR service under the direction of the Industry Director, Clinical Research and serves as a liaison between the PIs/Sub-Is, Sponsors, CROs, Service Research Leadership, and other research staff to ensure protocol adherence and study efficiency. Supports all phases of study conduct including feasibility, start-up, activation, enrollment, follow-up, monitoring, and close-out activities. Contributes to all aspects of ARJR industry research including: Assisting with protocol development and informed consent forms Recruitment and Enrollment process (conducts pre-screening, eligibility assessments, and informed consent process under PI supervision) Schedules and coordinates research study visits, facilitates completion of study procedures and assessments; Maintains real-time subject calendars and study tracking logs throughout study lifecycle to ensure visit adherence and completion of protocol requirements o Monitors and tracks reportable events including adverse events (AEs/SAEs), protocol deviations, device issues, and unanticipated problems under PI supervision; Promptly notifies PI of potential AEs/SAEs for review and reconciliation and ensures timely Sponsor/IRB reporting and documentation maintenance · Ensures that all research related regulatory, institutional, and departmental compliance requirements are met as appropriate. Responsibilities associated with specific studies include but are not limited to: Facilitates completion and submission of all documentation needed for research (e.g., IRB applications, amendments, reportable events, continuing reviews to ensure study renewals, conflict of interest forms, data collection forms, etc.) Facilitates completion and submission of Enrollment Milestones and invoiceable items via CTMS SMART for billing reconciliation; ClinicalTrials.gov registration, updates, and results reporting, in compliance with federal and institutional requirements o Maintains complete and audit-ready regulatory binders, including delegation of authority logs, training records, all IRB, Sponsor, and FDA correspondenceo Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of clinical research project management.o May handle and ship biospecimens Minimum Job RequirementsEducation / Training / Experience: Bachelor's degree required, Masters preferred 2+ years of experience in clinical research required; ACRP or SOCRA Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) preferred Prior experience with REDCap / EHRs (e.g., EPIC) / Electronic Data Captures, IRB Management platforms Knowledge of Human Subjects research regulations and HIPAA compliance; FDA regulations for clinical trials; Good Clinical Practice; Knowledge of Orthopaedic and/or Rheumatologic 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.