Clinical Research Associate Jobs in Oyster Bay, NY

Physician Affiliate Group of New York (PAGNY) at Lincoln Medical Center, a leading community hospital in the South Bronx, is seeking a Board-Certified/Board-Eligible Hematologist-Oncologist to serve as the Director of Clinical Oncology Research. This role combines clinical excellence, leadership in oncology research, and teaching responsibilities in a dynamic academic environment. The Director will lead and expand clinical trials and translational research programs while also providing compassionate patient care. New/Recent graduates are welcome. Lincoln Medical Center is affiliated with Weill Medical College of Cornell University. The Mission of NYC Health + Hospitals is to extend equally to all New Yorkers, regardless of the ability to pay, comprehensive health services of the highest quality in an atmosphere of humane care, dignity, and respect. Their Values are built on a foundation of social and racial equity and has established the ICARE standards for all staff. NYC Health + Hospitals is the nation's largest municipal health care delivery system in the United States. Dedicated to providing the highest quality health care services to all New Yorkers with compassion, dignity and respect, and regardless of immigration status or ability to pay. The Hematology/Oncology division is part of the Department of Medicine. It provides adult inpatient consultations across the hospital and runs a busy hematology/oncology outpatient service and infusion center. Teaching & Mentorship: Work closely with Internal Medicine residents Oversee and mentor Hematology/Oncology fellows rotating from New York Medical College Position Highlights: Academic Appointment: Affiliation with Weill Cornell Medical College State-of-the-art facilities including a busy 11-chair infusion center Schedule & Call: Monday through Friday, 8-hour shifts On-call coverage is phone-based only Research & Clinical Balance: 0.3 FTE dedicated to cancer research 0.7 FTE dedicated to clinical Hematology/Oncology practice Participation in oncology clinical research required, with an opportunity to serve as the local Principal Investigator Qualifications MD/DO degree from an accredited institution. Board Certified / Eligible in Hematology-Oncology. Eligible for medical licensure in New York. Experience in clinical trials, translational oncology research, or investigator-initiated studies. Strong commitment to academic medicine, mentorship, and patient-centered cancer care. Preferred (not required): Track record of peer-reviewed publications and research funding. Experience in early-phase trials, immunotherapy, or precision oncology. Leadership experience in an academic or clinical research setting is preferred but not required. This position offers an attractive compensation & benefits package; excellent work/life balance; clinical research and teaching opportunities; flexible starting date and schedule; reasonable call schedule. Wages and Benefits include: Annual Base Salary: $375,000* based on 40-hour work week. Additional compensation available for extra call or sessional/per diem hours. The annual total value of the compensation package is estimated at $450,000**, which includes the baseline salary, 401(k) contribution, and other factors as set forth below: Projected bonus of up to $40,000 (based on previous year's average), contingent upon meeting quality and productivity targets. 401(k) Company Contribution (subject to IRS contribution limits): Employees are immediately vested in a 3% company contribution of base earnings. No employee match is required. After one year of service, employees receive an additional 7% company contribution of base earnings. No employee match is required. Annual Continuing Medical Education (CME) Reimbursement. Generous Annual Paid Time Off (PTO): Vacation, Sick, Holiday, and CME days. Medical, Prescription, and Dental Coverage: Top-tier plans with employee contributions significantly below market rates. Life Insurance and Accidental Death and Dismemberment (AD&D) Coverage: Equal to 2x your salary (up to a maximum of $300,000) provided at no cost to you. Additional employee-paid Voluntary Life and AD&D coverage is available for you and your family. Loan Forgiveness: Position may be eligible for loan forgiveness through certain state or federal programs. Medical Malpractice Coverage (equivalent to occurrence-based): Provided at no cost to the employee. Healthcare and Dependent Care Flexible Spending Accounts (FSAs). Pre-tax employee-paid contributions for commuting expenses. Visa sponsorship will be considered for this position. Physician Affiliate Group of New York, P.C. (PAGNY) mission is to provide accountable, responsive, quality care with the highest degree of sensitivity to the needs of the diverse population that lives in our New York Community. PAGNY is one of the largest physician groups in the country and directly employs nearly 4,000 physicians and allied health professionals who provide services to NYC Health + Hospitals, the largest municipal health care system in the nation serving more than a million New Yorkers annually. Our providers are highly skilled professionals with outstanding credentials who deliver the highest level of quality healthcare to patients throughout New York City. Physician Affiliate Group of New York, P.C. (PAGNY) is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. We are committed to fostering an inclusive environment where everyone feels valued and respected. Our policies ensure equal opportunities for all. Learn more about our initiatives by visiting our Diversity, Equity, and Inclusion page. *Salary Disclosure Information: The annual base salary listed complies with the New York City law on Salary Transparency in Job Advertisements. The annual base salary listed is for full-time employment and does not include bonuses/incentive compensation or benefits. Actual total compensation depends on many factors, including experience, specialties, historical productivity, and historical collections. **The annual total value of the compensation package shown is provided as an illustration and is not guaranteed. Apply for this opportunity Click the button below to visit our job portal and fill out an application for this opportunity. #J-18808-Ljbffr

Assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical administrative support to study teams and on interacting with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Daiichi Sankyo (DS) Quality Oversight measures. Support and assist the transmittal of trial and site level document to the DS Document Control Center (DCC) in support of the Trial master File (TMF). Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the supervisor. Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov). Works with Insurance Brokers to obtain study site Insurance Under the guidance of the supervisor, analyze site metrics reports to identify potential areas of concern and bring to supervisor's attention. Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to the supervisor. Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices). Skills: Minimum of 1-year relevant experience is required. Veeva experience is a plus. Oncology experience is a plus. Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO). Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook. Basic oral and written communication skills. Education: Bachelor's degree required

Department Precision Employment Type Full Time Location Manhattan, New York Workplace type Onsite Compensation $125,000 - $135,000 / year Key Responsibilities Skills, Knowledge and Expertise About Precision Neuroscience Precision is building a direct connection between the human brain and computers, to benefit the hundreds of millions of people worldwide suffering from neurological conditions. Established in 2021, we are a leader in the development and commercialization of brain-computer interfaces (BCI). As a Precision employee, you will be collaborating with experts across a diverse array of fields-including neurosurgery, mechanical engineering, machine learning, and microfabrication-to push the boundaries of what is possible. You will be joining a well capitalized and fast-moving company. In the two years since Precision's founding, we have built and validated a product and have begun human trials in partnership with some of the country's leading neurosurgery programs. And you will be working toward a deeply meaningful goal: restoring function to people living with devastating neurological conditions, including stroke, spinal cord injury, traumatic brain injury, and neurodegenerative disease such as ALS. Our platform will enable these individuals to regain independence, communicate with loved ones, and return to work.

Syndax Pharmaceuticals is looking for a Clinical Research Associate At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: Perform a key role in building relationships with site Clinical Coordinators, Study Investigators, and Service Provider partners and contribute significantly to the execution of the clinical trial. Collaborate with cross-functional team members in this high-profile role. Communicate regularly with CTMs regarding work progress. Apply knowledge of clinical site oversight and other monitoring activities as a co-monitor with contract CRAs and as a primary site monitor for study sites. Key Responsibilities: Assist in the development of information/consent forms. Assist in the development of study training materials, study plans and study tools. Review Monitoring Plans and monitoring visit reports. Track metrics for monitoring visits and monitoring visit reports and document trends. Conduct remote and on-site monitoring oversight visits as specified in the Oversight Plan for each assigned study. Work closely with Clinical Supplies to resolve outstanding site action items. If applicable, ensure study drug blind is maintained in all interactions with blinded study team members and site staff. Ensure the Monitoring Plan is followed. Perform in-house clinical study data review. Collect and review study site regulatory documents for study start-up, annual reviews, and study close-out. Create and maintain study-related tracking tools. Participate as needed in site study drug training (unblinded CRA role). Assist in the maintenance of the clinical trial master file; perform study file audits. Participate in QC of study documents (protocol, ICF template(s), TMF, etc.) and the UAT of EDC and IRT systems. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance, or support and coordinate with the CRO's CRAs on these activities. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audits, Health Authority Inspections and required follow-up actions. Daily interaction with Clinical Operations management and members of the cross-functional study team. Work with the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., CRO, Vendors, Regulatory, Investigator Sites, etc.). Lead and partake in regular team meeting/teleconferences; Participate/present at CRO, Vendor and Investigator Site meetings as necessary; Participate/present at Site and Investigator Meetings as necessary. Communicate any Site, CRO or Vendor escalations or issues to upper management as soon as identified. Desired Experience/Education and Personal Attributes: BS degree in life sciences or healthcare discipline, Master's degree is preferred; at least 3 years of clinical operations experience including at least 2 years of experience monitoring oncology trials preferred. Knowledge of good clinical practice (GCP) and FDA and ICH regulations and guidelines. Good verbal and written communication skills; enjoys frequent interaction with others. Able to prioritize tasks and work independently. Works collaboratively in a small team environment. Experience working with Risk-Based Monitoring and Centralized Monitoring Experience working with EMR, EDC, eTMF and CTMS systems. Able to travel an average of 25%, both domestically and internationally. Location: Syndax's corporate office is in New York, NY. Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $110,000 -$125,000. About Syndax: Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit *************** or follow the Company on X (formerly Twitter) and LinkedIn. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. #LI-remote

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

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office. Under general supervision, the Clinical Research Associate - IVI is responsible for performing series of qualitative and quantitative analyses of patient intravascular image (IVI)s. ESSENTIAL DUTIES AND RESPONSIBILITIES Acts as a point person for assigned trials Responsible for setting up new trial documentation, Case Report Forms, Technician Worksheets; uses templates and revises for assigned client Becomes familiar with protocols and sub study for assigned client. Creates or revises, as needed, for review by Medical Director and Assistant Director, IVI Creates initial database/excel spreadsheet to track work Acquires images, logs work that is being completed Archives, digitizes, controls the quality, and performs measurements and image interpretation of intravascular ultrasound (IVUS), Virtual HistologyTM (VH)-IVUS, optical coherence tomography (OCT), near infrared spectroscopy (NIRS), and physiology recordings received in the core lab, related to ongoing contracted studies Follows training IVUS, VH-IVUS, OCT, NIRS, physiology and any other intravascular imaging modalities to maintain consistency of readings Responsible for analysis of assigned trials Receives and answers queries; contacts site coordinators or PIs and works with the sponsor to resolve issues May be responsible for data management activities Responsible for additional research, presentation, and academic activities as assigned Initially works in catheterization laboratory once a week or at department director's discretion to understand how to set up the ultrasound scanner, perform on-line measurements and understand basic coronary anatomy and principle of percutaneous interventions Additional duties as assigned QUALIFICATIONS B.A. or B.S. degree in Biomedical Engineering or Life Sciences 0 - 2 years working experience in a medical, academic or pharmaceutical environment Knowledge of medical terminology and morphology of the heart preferred Must be proficient in Microsoft Excel, Word, and Outlook Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment Ability to verbally communicate effectively with staff, physicians, nurses, managers, trial sponsors and colleagues. Ability to communicate effectively when reading and writing e-mail, letters, Manual of Operations, Case Report Forms and other reports or company documents Ability to analyze information and solve problems relating to intravascular images BENEFITS Choice of health plans include medical, Dental, and vision coverage Company-paid short-term and long-term disability and life insurance Health and dependent care flexible spending accounts Pre-tax travel expenses through TransitChek program 401(k) plan Generous paid time off (PTO) Ten paid holidays each year COMPENSATION The hiring range for this position is $52,000 - $58,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience. CONTACT INFORMATION To be considered for this opportunity, please submit your resume. Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day *********** CRF is an equal opportunity employer.

Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinical research nurses and team. Responsibilities Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols. Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team. Ensure compliance with the Good Clinical Practice guidelines in clinical research. Monitor study patients for adverse events in collaboration with clinical team and report as required. Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements. Qualifications Education requirement: BS Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments. Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit-risk profile throughout the product lifecycle. Independently leads activities without supervision for assigned clinical studies. Lead activities under the direction of Clinical Safety Scientist Product Lead. Develop expertise in one or more focus areas (SME). Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies through inspection readiness preparation. Responsibilities Risk Management (Signal Identification, Evaluation, Mitigation) Supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, PSL, Clinical Safety Physician(s), and cross-functional team(s). Collaborates with Clinical Safety Scientist Lead and PSL or Clinical Safety Physician(s) to evaluate safety data of any source to identify potential safety signals, track safety signals in the global electronic signal tracking tool, and perform safety analysis/evaluation. May contribute to safety action recommendations, communication, and risk minimization plans. Presents assessments to appropriate forums, including the Safety Management Team (SMT) or other cross-functional teams. Collaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentations, safety analyses/evaluations, etc.) for SMT/Product-level safety meetings. Collaborates with Clinical Safety Scientist Product Lead and PSL to develop minimum core product safety requirements for inclusion in Clinical Study Protocols (CSPs) and Informed Consent Forms (ICFs). Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned product. Safety Communication Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documents. Collaborates with Clinical Safety Scientist Lead and PSL to author safety sections of the Investigator's Brochure, aggregate reports (DSUR/PLL), prescribing information, Company Core Data Sheet (CCDS), Risk Management Plans (RMPs). Contributes to regulatory authority requests or communication for assigned clinical studies. CTD Submissions / Other May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical Safety Physician(s), PSL, and cross-functional team to develop safety strategy, key safety messages, and review/author safety sections of CTD. Develops expertise in one or more focus areas. Supports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as needed. Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies through inspection readiness preparation. Project Management Coordinates SMT/Product-level safety meetings, maintains roster, calendar, and minutes, and communicates materials in support of the Clinical Safety Scientist Product Lead and PSL. May serve as a project manager for other activities involving assigned product(s) or clinical studies, as needed. Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Bachelor's Degree (minimum required) PharmD preferred PhD preferred Experience Qualifications Possesses scientific or therapeutic area and drug development knowledge (preferred). 0-1 year of experience with an advanced degree required. 2-3 years of experience with a Bachelor's degree required. Travel Ability to travel up to 10% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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 provide 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 Maimonides is currently seeking a Clinical Trials Support Specialist. Responsibilities We currently have a unique full time opportunity for a Clinical Trials Support Specialist in our Cancer Center Administration Department. Qualifications We require: Bachelor's of Science in Biology or Chemistry; Master's preferred. 2 years of research experience in the medical field or an advanced degree in a Biology or Chemistry required. Pay Range USD $66,779. 00 - USD $66,779. 00 /Yr. Equal Employment Opportunity Employer Maimonides Medical Center (MMC) is an equal opportunity employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard for race, creed (religion), color, sex, national origin, ethnicity, sexual orientation, gender identity, military or veteran status, age, disability, pregnancy, predisposing genetic characteristic, marital status or domestic violence victim status, citizenship status, or any other factor which cannot lawfully be used as a basis for an employment decision in accordance with applicable federal, state, and local laws. MMC is committed to following the requirements of the New York State Human Rights Law with regard to non-discrimination on the basis of prior criminal conviction and prior arrest.

What We Do Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. Who We Are We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. Position Overview The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. What You'll Be Working On Duties include but not limited to: ● Ability to understand and follow institutional SOPs. ● Review and assess protocol (including amendments) for clarity, logistical feasibility ● Ensure that all training and study requirements are met prior to trial conduct. ● Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. ● Assist with planning and creation of appropriate recruitment materials. ● Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. ● Actively work with recruitment team in calling and recruiting subjects ● Attend Investigator meetings as required. ● Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. ● Assist in the creation and review of source documents. ● Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) Study Management: ● Prioritize activities with specific regard to protocol timelines ● Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. ● Maintain effective relationships with study participants and other care Access Research personnel. ● Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. ● Communicate clearly verbally and in writing. Patient Coordination: ● Prescreen study candidates ● Obtain informed consent per Care Access Research SOP . ● Complete visit procedures in accordance with protocol. ● Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. ● Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. ● Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Documentation: ● Record data legibly and enter in real time on paper or e-source documents ● Accurately record study medication inventory, medication dispensation, and patient compliance. ● Resolve data management queries and correct source data within sponsor provided timelines ● Assist regulatory personnel with completion and filing of regulatory documents. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Physical and Travel Requirements * This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. What You Bring Knowledge, Skills, and Abilities: ● Excellent working knowledge of medical and research terminology ● Excellent working knowledge of federal regulations, good clinical practices (GCP) ● Ability to communicate and work effectively with a diverse team of professionals. ● Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail ● Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. ● Critical thinker and problem solver ● Friendly, outgoing personality; maintain a positive attitude under pressure. ● High level of self-motivation and energy ● Excellent professional writing and communication skills ● Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: ● Bachelor's Degree preferred, or equivalent combination of education, training and experience. ● A minimum of 3 years prior Clinical Research Coordinator experience required ● Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator ● Recent phlebotomy experience required * Bilingual in Spanish-preferred Benefits (US Full-Time Employees Only) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with the physicians and caring for patients. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is currently unable to sponsor work visas. Employment Statement Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.

Job Details 4CC - New York, NY Job Title: Clinical Research Coordinator General Description: The Clinical Research Coordinator will assist our Research Project Manager with the coordination of research IVF cycles and fertility patient treatments. Essential Functions: Administrative enrollment of new patients for the clinical investigation in infertility. Handle patients going through the process of enrollment, answer science and logistics questions regarding the clinical investigation in infertility. Introduce patients to Informed Consent Forms, and follow through with patients until completion of documents. This includes answering questions and calls & meeting with patients to discuss and/or receive documents. Maintain patient charting, update records and file completed Informed Consent Forms. Consult with project manager and Medical Director to educate enrolling patients on the experimental IVF program described in the Informed Consent Forms. Telephone triage with patients regarding updates on the progress of their cycle, patient medication, treatment plans, test results, and patient related issues. Communicate with patient and our clinical staff or patient provider to collect medical records required for embryo transfers, if necessary. Responsible for accurate and timely communication of clinical updates to patients. Responsible for keeping patients up to date on the progress of the clinical investigation, and communicate any patient requests for changes in their cycle to the project manager. Provide compassion and emotional support to patients throughout the clinical investigation in infertility. Work with project manager to schedule patient oocyte shipments for the clinical investigation in infertility. Ability to remain calm and respond appropriately to all stressful situations. Knowledge of OSHA, FDA, and HIPAA compliance. Excellent communication and interpersonal skills. Strong communication skills with professional yet friendly etiquette providing the utmost customer care. Requirements: Minimum bachelor's degree, preferably in Biology or Biomedical Sciences. Previous experience in patient facing research setting. Preferred 2-3 years' experience in an infertility medical setting OR in a medical research setting. Excellent work ethic and ability to work both independently and as part of a team. Meticulous organizational skills and attention to detail. Excellent time-management, customer service, and critical-thinking skills. Ability to work well in a fast-paced environment while maintaining composure and an individualized, compassionate approach to patient care. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

The Clinical Research Coordinator II (CRC II) is primarily responsible for coordinating the operational aspects of ongoing clinical projects to ensure that the clients' goals of time, cost, and quality are met. The CRC II may serve as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines. The CRC II may also serve as the project lead responsible for directing internal teams in the execution of the protocol and ensuring that all staff working on any given protocol have been properly delegated by the Principal Investigator and adequately trained on the protocol. RESPONSIBILITIES Oversees compliance with study protocols; manages quality control, completion and submission of study related documentation; prepares reports for study sponsor and regulatory agencies Coordinates and performs responsibilities related to research participants including: determining subject population availability, developing informed consent forms and screening materials, screening and recruitment of subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits, completion of subjects' assessment(s), charting, collection of biological samples (e.g., blood, urine), medical testing (e.g., vital signs), and processing of data and samples collected during subject visits, recognizes, tracking and reporting of adverse events and protocol deviations Develops and maintains patient databases, investigational logs, study regulatory documents, including screening and enrollment logs, drug accountability logs, subject identification logs, and site signature and records of drugs administered, medical devices monitored and/or procedures followed Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance, develops report formats and tracks subject recruitment activity Monitors study expenses and billing for study services, requests change orders/amendments as necessary Serves as primary contact with the sponsor regarding overall study conduct, timelines, and budget. Prepares, submits and maintains Institutional Review Board (IRB) and /or other regulatory documents and research correspondence. Trains clinical staff on study protocols and procedures and supervises the Clinical Research Unit (CRU) staff when the principal investigator or sub-investigators are not present to direct clinical research activity Conducts quality control (QC) checks of the work of self and others to ensure that work quality is acceptable, meets protocol standards, and is compliant with regulatory requirements Develops, completes and/or maintains site documentation including but not limited to case report forms (CRFs), data clarification forms (DCFs), source files and regulatory documents Oversees storage of documents, as appropriate, in temporary and long-term storage in accordance with standard procedures Communicates pertinent information to other staff members who may be involved in research (e.g., physicians, laboratory technologists). This includes the development of meetings or materials intended to serve as a resource for other staff. Ensures all staff working on a project have been properly delegated by the Principal Investigator and have received adequate protocol training. Represents Clinilabs at investigator meetings as needed, attendance at other meetings with study sponsors or their agents as needed Responsible for tracking subject recruitment and enrollment and reporting safety issues including SAE tracking Oversees the ordering and shipment of study drug supply, ensuring that drug accountability logs are maintained with the Pharmacy. Coordinates study start-up activities with the sponsor and internal staff including the Site Initiation Visit. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues. Prepares for, coordinates and hosts site visits made by sponsors or federal agencies during course and at the close of the study and works independently with such parties to ensure source documents and case report forms are complete, queries are resolved, and required regulatory documentation is in place. Conducts all work in accordance with Good Clinical Practices (GCPs), Corporate Standard Operating Procedures (SOPs), and principles set forth in the CFR and ICH guidelines. Communicates with sponsors and CROs regarding pertinent issues (e.g., deviations and exemptions, enrollment statistics). Responsible for study close-out, coordination of data query resolution, and database lock to meet study timelines. Other duties as assigned TRAVELING Between Corporate New Jersey and New York units, as needed. Exact compensation may vary based on skills, experience, and location. For NYC, the salary range is $60k-$65K Requirements The position requires at least a High School Diploma, but a Bachelor's degree in one of the basic sciences or a related field is strongly preferred. Some experience in clinical research is strongly preferred and may be required depending on current needs. The position of CRC II requires good management and organizational skills, understanding of medical procedures, exceptional interpersonal skills, the ability to work independently and lead a project specific team, strong computer skills and writing ability. The CRC II is expected to serve as the “command center” for assigned research studies, interacting extensively with sponsors, investigators, review boards, and study subjects. The CRC II provides leadership and supervision for the research assistants (RAs) and medical techs during the course of research studies assigned to them and they are involved in study assignments and resource staffing for their projects. The CRC II must meet course requirements for Good Clinical Practices (GCPs), infection control, handling of hazardous materials, basic cardiac life support (BCLS), and other specific study-related training.

Schedule: 8 hour shift, Monday-Friday About Sadick Dermatology Sadick Dermatology is a premier dermatology practice on Manhattans Upper East Side, internationally recognized for its advanced medical, cosmetic, and clinical research offerings. Led by renowned dermatologist Dr. Neil Sadick, our practice blends cutting-edge innovation with personalized patient care and a deep commitment to excellence in dermatologic research. Learn more about us at ****************************** About the Role Our fast-paced, dynamic research group is looking for an exceptional Clinical Research Assistant to join our team. We are one of the leading private sites for research in Dermatology in the country and offer excellent opportunities for growth. As a group, we believe in investing in our employees, developing their skills and facilitating their potential . The ideal candidate will be a medical assistant or certified phlebotomist, with research experience and will possess the essential skills and abilities listed below. We offer a competitive salary and benefits with room for growth within the company. Under general supervision, the Clinical Research Assistant aids the CRC in patient visits and all protocol associated requirements including to but not limited to collecting and entering clinical data, sample collection, processing and shipment, administrative tasks, patient recruitment, advertising, patient database management. Key Responsibilities Study Coordination & Patient Engagement Serve as the primary contact for study participants, providing guidance and support throughout the trial with empathy and professionalism. Conduct study visits per protocol, including basic clinical evaluations (e.g., vital signs, EKGs), medication review, and documentation of adverse events. Maintain accurate source documentation and perform timely eCRF/EDC data entry to ensure high-quality data and avoid reporting delays. Protocol & Regulatory Compliance Learn and apply complex dermatology protocols with precision Obtain and document informed consent in accordance with GCP and IRB requirements. Maintain study drug accountability and ensure compliance with all regulatory guidelines, IRB processes, and site SOPs. Support site monitoring visits, audits, and inspections. Site Operations Collaborate with investigators, site staff, and external partners (e.g., CROs, central labs, sponsors) to ensure smooth trial execution. Coordinate and schedule study visits, manage medical records, and ensure readiness through visit planning and communication. Manage participant scheduling and implement strategies to support retention and visit adherence throughout the study. Track recruitment, manage study supplies and sample logistics, and proactively address site-level challenges. Collect, process, and ship clinical specimens per protocol and IATA guidelines. Set up and maintain clinical research equipment to support accurate data collection. Support study startup and closeout activities, including archiving and document reconciliation. Training & Team Collaboration Informally mentor junior staff on good documentation practices and protocol adherence. Contribute to a collaborative, high-performing team culture focused on operational excellence and patient-centered care. Qualifications Bachelors degree At least 2 years of experience coordinating clinical trials; Phase 3 or high-enrolling (20+ subject) studies preferred. Strong documentation skills and familiarity with EDC systems; experience with CTMS, IVRS/IWRS, and ICH-GCP a plus. Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook); able to learn and adapt quickly to new technologies. Exceptional organizational and multitasking skills; able to work independently and problem-solve in real time. Flexible, composed, and effective communicator with both clinical teams and patients in a fast-paced setting. CCRC or CCRP certification preferred but not required. Strong phlebotomy skills required Experience in dermatology, cardiology, or targeted therapies is a plus, but not required. Compensation and Benefits $50,000-$55,000 USD Annual Salary Sadick Dermatology offers competitive compensation commensurate with experience and a generous benefits package inclusive of a 401(k), Medical/Dental/Vision insurance, and paid time off Equal Opportunity Employer Sadick Dermatology is an equal opportunity employer. All employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, or age.

Job Title : Clinical Research Coordinator Department : Site Operations Reports To : Site Manager Status : Non-exempt (hourly) Compensation : $17.00 - $19.00 : We are seeking a reliable and experienced Clinical Research Coordinator to join our growing team at Elite Clinical Network. This position will be responsible for collaborating with the Principal Investigator, human subjects, IRB, and pharmaceutical company to ensure smooth, accurate progress of clinical trials from the planning stage through trial completion and post-study closure. Ideal candidates will possess working knowledge of clinical trial procedures. Essential Duties: Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities Provides accurate and timely data collection, documentation, entry, and reporting Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants Qualifications : Bachelor's degree or certified Medical Assistant If you are a dedicated and reliable Clinical Research Coordinator, we invite you to apply for this exciting opportunity. Join us and be a key player in shaping the future of our business. ECN is an equal opportunity employer. We make every effort to make our hiring process accessible to all users. If you need assistance completing the application process, please contact Human Resources via *********************************

div class="" id="content" pstrong Syndax Pharmaceuticals is looking for a uClinical Research Associate/u/strong/p pstrong /strong/p pAt Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies./p pstrong /strong/p pstrong The Role: /strong/p pPerform a key role in building relationships with site Clinical Coordinators, Study Investigators, and Service Provider partners and contribute significantly to the execution of the clinical trial. Collaborate with cross-functional team members in this high-profile role. Communicate regularly with CTMs regarding work progress. Apply knowledge of clinical site oversight and other monitoring activities as a co-monitor with contract CRAs and as a primary site monitor for study sites.strong /strong/p pstrong /strong/p pstrong Key Responsibilities:/strongstrong /strong/p ul li Assist in the development of information/consent forms./li li Assist in the development of study training materials, study plans and study tools./li li Review Monitoring Plans and monitoring visit reports./li li Track metrics for monitoring visits and monitoring visit reports and document trends./li li Conduct remote and on-site monitoring oversight visits as specified in the Oversight Plan for each assigned study./li li Work closely with Clinical Supplies to resolve outstanding site action items./li li If applicable, ensure study drug blind is maintained in all interactions with blinded study team members and site staff./li li Ensure the Monitoring Plan is followed./li li Perform in-house clinical study data review./li li Collect and review study site regulatory documents for study start-up, annual reviews, and study close-out./li li Create and maintain study-related tracking tools./li li Participate as needed in site study drug training (unblinded CRA role)./li li Assist in the maintenance of the clinical trial master file; perform study file audits./li li Participate in QC of study documents (protocol, ICF template(s), TMF, etc.) and the UAT of EDC and IRT systems./li li Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance, or support and coordinate with the CRO's CRAs on these activities./li li Provides guidance at the site and project level towards audit readiness standards and supports preparation for audits, Health Authority Inspections and required follow-up actions./li li Daily interaction with Clinical Operations management and members of the cross-functional study team./li li Work with the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., CRO, Vendors, Regulatory, Investigator Sites, etc.)./li li Lead and partake in regular team meeting/teleconferences; Participate/present at CRO, Vendor and Investigator Site meetings as necessary; Participate/present at Site and Investigator Meetings as necessary./li li Communicate any Site, CRO or Vendor escalations or issues to upper management as soon as identified./li /ul pstrong /strongstrong /strong/p pstrong Desired Experience/Education and Personal Attributes:/strongstrong /strong/p ul li BS degree in life sciences or healthcare discipline, Master's degree is preferred; at least 3 years of clinical operations experience including at least 2 years of experience monitoring oncology trials preferred./li li Knowledge of good clinical practice (GCP) and FDA and ICH regulations and guidelines./li li Good verbal and written communication skills; enjoys frequent interaction with others./li li Able to prioritize tasks and work independently./li li Works collaboratively in a small team environment./li li Experience working with Risk-Based Monitoring and Centralized Monitoring/li li Experience working with EMR, EDC, eTMF and CTMS systems./li li Able to travel an average of 25%, both domestically and internationally./li /ul pstrong /strong/p pstrong Location/strong: Syndax's corporate office is in New York, NY./p p /p pSyndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $110,000 -$125,000./p pstrong /strong/p pstrong /strongstrong About Syndax:/strongbr/Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit a href="*********************************************************************************************************************************************** or follow the Company on a href="https://c212.net/c/link/?t=0amp;l=enamp;o=4320128-1amp;h=**********amp;u=https%3A%2F%2Fx.com%2Fsyndax%3Flang%3Den%26mx%3D2amp;a=X+(formerly+Twitter)%C2%A0"X (formerly Twitter) /aand a href="************************************************************************************************************************************************************************ pem /em/p pem Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law./em/p pem /em/p pspan style="color: #ffffff;"#LI-remote/span/p /div

span id="spandesc"p style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif; font-size:13. 3333px; letter-spacing:normal; font-weight:400; line-height:1. 43; color:rgb(45, 45, 45); font-style:normal; orphans:2; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px'Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. br//pp style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif; font-size:13. 3333px; letter-spacing:normal; font-weight:400; line-height:1. 43; color:rgb(45, 45, 45); font-style:normal; orphans:2; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px'b style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Essential Duties And Responsibilities/bbr//pul style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif; font-size:13. 3333px; letter-spacing:normal; font-weight:400; line-height:1. 43; color:rgb(45, 45, 45); font-style:normal; orphans:2; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px'li style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Participate and assist in design and preparation of protocols and case report forms. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Participate in the evaluation of potential clinical sites according to established criteria of acceptability. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Assist with the maintenance of clinical archive and electronic files. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Other tasks as assigned. br//li/uldivbr//div/spanbr/span id="spanreq"h3Requirements/h3p style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif; font-size:13. 3333px; letter-spacing:normal; font-weight:400; line-height:1. 43; color:rgb(45, 45, 45); font-style:normal; orphans:2; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px'To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. br//pul style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif; font-size:13. 3333px; letter-spacing:normal; font-weight:400; line-height:1. 43; color:rgb(45, 45, 45); font-style:normal; orphans:2; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px'li style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'BA, BS, RN, BSN or equivalentbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Basic knowledge and adherence to GCPsbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'3+ years of clinical research experiencebr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Strong attention to detailbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Ability to multi-taskbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Unquestionable integrity and highest ethical standardsbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Excellent written and verbal communication skillsbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Self-motivated, assertive, and drivenbr//li/uldivbr//div/spanbr/

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary * This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit-risk profile throughout the product lifecycle. * Independently leads activities without supervision for assigned clinical studies. * Lead activities under the direction of Clinical Safety Scientist Product Lead. * Develop expertise in one or more focus areas (SME). * Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies through inspection readiness preparation. Responsibilities Risk Management (Signal Identification, Evaluation, Mitigation) * Supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, PSL, Clinical Safety Physician(s), and cross-functional team(s). * Collaborates with Clinical Safety Scientist Lead and PSL or Clinical Safety Physician(s) to evaluate safety data of any source to identify potential safety signals, track safety signals in the global electronic signal tracking tool, and perform safety analysis/evaluation. * May contribute to safety action recommendations, communication, and risk minimization plans. Presents assessments to appropriate forums, including the Safety Management Team (SMT) or other cross-functional teams. * Collaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentations, safety analyses/evaluations, etc.) for SMT/Product-level safety meetings. * Collaborates with Clinical Safety Scientist Product Lead and PSL to develop minimum core product safety requirements for inclusion in Clinical Study Protocols (CSPs) and Informed Consent Forms (ICFs). * Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned product. Safety Communication * Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documents. * Collaborates with Clinical Safety Scientist Lead and PSL to author safety sections of the Investigator's Brochure, aggregate reports (DSUR/PLL), prescribing information, Company Core Data Sheet (CCDS), Risk Management Plans (RMPs). * Contributes to regulatory authority requests or communication for assigned clinical studies. CTD Submissions / Other * May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical Safety Physician(s), PSL, and cross-functional team to develop safety strategy, key safety messages, and review/author safety sections of CTD. * Develops expertise in one or more focus areas. * Supports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as needed. * Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies through inspection readiness preparation. Project Management * Coordinates SMT/Product-level safety meetings, maintains roster, calendar, and minutes, and communicates materials in support of the Clinical Safety Scientist Product Lead and PSL. * May serve as a project manager for other activities involving assigned product(s) or clinical studies, as needed. Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) * Bachelor's Degree (minimum required) * PharmD preferred * PhD preferred Experience Qualifications * Possesses scientific or therapeutic area and drug development knowledge (preferred). * 0-1 year of experience with an advanced degree required. * 2-3 years of experience with a Bachelor's degree required. Travel * Ability to travel up to 10% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

What We DoCare Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. Who We AreWe care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. Position OverviewThe Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. What You'll Be Working OnDuties include but not limited to:● Ability to understand and follow institutional SOPs.● Review and assess protocol (including amendments) for clarity, logistical feasibility● Ensure that all training and study requirements are met prior to trial conduct.● Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.● Assist with planning and creation of appropriate recruitment materials.● Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.● Actively work with recruitment team in calling and recruiting subjects ● Attend Investigator meetings as required. ● Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.● Assist in the creation and review of source documents.● Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) Study Management:● Prioritize activities with specific regard to protocol timelines● Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.● Maintain effective relationships with study participants and other care Access Research personnel.● Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.● Communicate clearly verbally and in writing. Patient Coordination:● Prescreen study candidates ● Obtain informed consent per Care Access Research SOP .● Complete visit procedures in accordance with protocol.● Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.● Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.● Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Documentation:● Record data legibly and enter in real time on paper or e-source documents ● Accurately record study medication inventory, medication dispensation, and patient compliance.● Resolve data management queries and correct source data within sponsor provided timelines● Assist regulatory personnel with completion and filing of regulatory documents.Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.Physical and Travel Requirements· This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. What You Bring Knowledge, Skills, and Abilities:● Excellent working knowledge of medical and research terminology● Excellent working knowledge of federal regulations, good clinical practices (GCP)● Ability to communicate and work effectively with a diverse team of professionals.● Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail● Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.● Critical thinker and problem solver● Friendly, outgoing personality; maintain a positive attitude under pressure.● High level of self-motivation and energy● Excellent professional writing and communication skills● Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience:● Bachelor's Degree preferred, or equivalent combination of education, training and experience.● A minimum of 3 years prior Clinical Research Coordinator experience required● Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator ● Recent phlebotomy experience required -Bilingual in Spanish-preferred Benefits (US Full-Time Employees Only)· Paid Time Off (PTO) and Company Paid Holidays· 100% Employer paid medical, dental, and vision insurance plan options· Health Savings Account and Flexible Spending Accounts· Bi-weekly HSA employer contribution· Company paid Short-Term Disability and Long-Term Disability· 401(k) Retirement Plan, with Company Match Diversity & InclusionWe serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with thephysicians and caring for patients. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is currently unable to sponsor work visas. Employment StatementCare Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.

Job Title: Clinical Research Coordinator Department: Site Operations Reports To: Site Manager Status: Non-exempt (hourly) Compensation: $17.00 - $19.00 We are seeking a reliable and experienced Clinical Research Coordinator to join our growing team at Elite Clinical Network. This position will be responsible for collaborating with the Principal Investigator, human subjects, IRB, and pharmaceutical company to ensure smooth, accurate progress of clinical trials from the planning stage through trial completion and post-study closure. Ideal candidates will possess working knowledge of clinical trial procedures. Essential Duties: Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities Provides accurate and timely data collection, documentation, entry, and reporting Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants Qualifications: Bachelor's degree or certified Medical Assistant If you are a dedicated and reliable Clinical Research Coordinator, we invite you to apply for this exciting opportunity. Join us and be a key player in shaping the future of our business. ECN is an equal opportunity employer. We make every effort to make our hiring process accessible to all users. If you need assistance completing the application process, please contact Human Resources via *********************************