Clinical Research Coordinator Jobs in Clarkstown, NY

Clinical research study point of contact and accountable for coordination of each assigned trial from beginning to the end under the direction of the Principal Investigator, Sub-investigator, and Clinical Trial Management in adherence to the FDA, ICH-GCP, IRB, HIPAA, RCCA SOPs, US Oncology Compliance Program, RCCA Code of Ethics and Business Standards. Employment Type: Full Time Location: Riverdale, NJ 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, Employee-paid critical illness and accident insurance. 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 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.

The Clinical Research Data Scientist is responsible for the data extraction, cleaning, compilation, and analysis of data related to clinical research studies, projects, and publications. Duties and Responsibilities: Management of clinical research data, including: Data pulls/data mining Data cleaning Data and statistical analysis of pulled data from large data sets Preparation of data (charts, tables) for presentation and for publications (abstracts and manuscripts) Additional responsibilities related to the management and coordination of new and existing clinical research projects: may include, but are not limited to, administrative duties, regulatory compliance, clinical operations, and study monitoring. Other duties as assigned Required Skills and Abilities: Proficiency with Advanced Excel Proficiency with SQL and Power BI Proficiency with Microsoft Office Suite products (Word, Excel, PowerPoint, Outlook, etc.) Experience with Data analysis software: SAS, R, Python, etc. Background knowledge in science and/or Biostatistics and its application to clinical data Prior experience with manuscript preparation including preparation of tables, figures, charts Experience in the collection, analysis and presentation of complex clinical data including large data sets from multiple data sources Ability to review literature, read and apply information from literature reviews to CDx's current and future research projects To work under the direction of the Director of Research in the design and implementation of clinical studies. Project Management Must have excellent organizational skills with meticulous attention to detail Strong collaboration and communication skills within and across teams Ability to multi-task and prioritize Ability to function under pressure and meet deadline-oriented project demands as well as manage multiple initiatives Ability to work effectively in a self-guided manner and in an interdisciplinary team environment Critical thinking and problem-solving Ability to adapt workflows to technical and regulatory constraints to facilitate the execution and ongoing success of CDx's clinical studies. Education and Experience: Bachelor's degree in data science, Health Science, Health Care Information, Biostatistics, Computer Science, or related research field. Master's degree preferred. Minimum 2-3 years prior experience with clinical research data analysis and manuscript preparation. Work Environment & Physical Demands: This is a full-time position, based in the Suffern, NY office. Work is performed in an office environment and requires the ability to operate standard office equipment Prolonged periods of sedentary work that requires sitting at a desk and working on a computer 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. We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status or any other status protected under federal, state or local law. We participate in E-Verify.

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

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Title: Clinical Research Scientist Duration: 12 Months (Possibility of Extension) Location Woodcliff lake NJ Job Responsibilities: The incumbent is responsible for, but not limited to the following: Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) Performs literature search and data analysis to address research questions In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) Assisting in database cleaning, review of study results, and interpretation of results Adhering to key performance indicators for clinical study development, conduct, and reporting Individual contributor with specialized knowledge Presents concepts, facts, and reports and advises on key trends and issues Troubleshooting routine site inquiries Work is completed under limited supervision Supports the planning, execution and reporting of clinical programs/trials May handle multiple protocols simultaneously Contributes to risk resolution by escalating and monitoring project risks Qualifications Qualifications Minimum of 2-5 years of experience in clinical research in the pharmaceutical industry A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; Bachelor's Required. Doctoral (PharmD or PhD) or MD degree preferred . Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus Thank you for your time and consideration. I look forward to hearing from you! Kind Regards Ruchi Kumari Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO Certified MBE | GSA - Schedule 66 I GSA - Schedule 621I (DIRECT BOARD) # 732-844-8716 (F) 732-549-5549 LinkedIn: https://www.linkedin.com/in/ruchi-kumari Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with overall study execution. The CRA may also assist with data management, vendor management and site monitoring as needed. Duties and Responsibilities Act as the primary point of contact with assigned clinical study sites during start-up activities; Working with finance and legal experts, drive contract and budget negotiations (or amendments) with assigned sites; Review site-level documents needed for IRB/EC/REC approval; Support study initiation, monitoring, audit and close-out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan; Ensure clinical study site documentation compliance according to GCPs, ICH and FDA regulations; Provide relevant, timely study subject updates to the Clinical Study Manager(s) (e.g., upcoming treatment dates, subject withdrawals, etc.); Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors; Collaborate with clinical study site and sponsor to troubleshoot and provide appropriate solutions to study-related issues, as appropriate; Assist in patient recruitment activities; Assist with the development of study-related documents as requested; Prepare accurate and timely study reports as requested; Work independently and under general supervision. Education Bachelor's degree (or higher) in nursing, health sciences or related field; Qualifications Experience with clinical trial contract and budget negotiations Finance experience preferred Minimum of two years of CRA experience, with clinical site monitoring experience preferred; Strong oral and written communication skills; Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance; Proven organizational skills and the ability to manage multiple priorities; Strong computer skills; Ability to travel with adequate prior notification

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

**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. At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.

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 3+ years of clinical research experience 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

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.

ASSISTANT CLINICAL RESEARCH COORDINATOR / EQUIPMENT SUPERVISOR Reports to: Clinical Operations Manager or equivalent. Supervises: None Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Qualifications: Experience: Six months to two years of similar or related experience. Education: High School diploma/certificate or educational equivalent; or equivalent combination of education, training, and experience; BS/BA preferred. Minimum Skills: Experience with EMR, MS Word, Excel, MS outlook. Interpersonal Skills: A significant level of trust and diplomacy is required, in addition to normal courtesy and tact. Work involves extensive personal contact with others and/or is usually of a personal or sensitive nature. Experience: Must possess a general knowledge of applicable clinical research regulatory requirements; general knowledge of GCP and ICH guidelines is preferred. Strong computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint. Strong written and verbal communication skills. Effective time management and organizational skills. Attention to detail and accuracy in work. Knowledge of applicable protocol requirements Specific Responsibilities: Assists the Clinical Research Coordinator in developing strategies for implementing study procedures in compliance with the study protocol. Organize and maintain patient research charts and other research documentation. Conduct patient research visits in conjunction with nursing staff and physician, following written instructions per protocol. Screen potential research patients for study eligibility and communicate research studies to eligible participants and obtain informed consent. Interact in a professional manner with pharmaceutical company representatives, physicians, and other staff to obtain and review data. Accurately update and maintain clinical systems within project timelines; prepare, handle, distribute, file, and archive clinical documentation and reports; review study files periodically for accuracy and completeness; prepare, handle and distribute Clinical Trial Supplies and maintenance of tracking information; track and manage Case Report Forms (CRFs), queries and clinical data flow. Follow written direction and protocols precisely. Multi-task for a variety of projects. Assists to determine methods and procedures on new assignments and may supervise the activities of other Clinical Services personnel (e.g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters.) Ensure that company SOPs and procedures pertaining to equipment maintenance are being followed. Ensure compliance with all equipment maintenance requirements. Maintain medical equipment records. Perform routine and organized inventory of all company equipment. Assists QA in IQ/OQ/PQ and validation/calibration of new equipment/devices. Perform medical equipment inspections and preventive maintenance. Collaborate with project managers/study coordinators in medical equipment rentals/purchases. Collaborate with IT in the rental/purchase/installation and maintenance of any software/hardware that is equipment related. Ensure parts/replacements are readily available without overstocking. Monitor the effective use of existing equipment and determine the need for additional equipment. Provide basic training to staff on how to maintain/operate equipment in an optimal manner. Assist Frontage staff in solving day-to-day equipment maintenance issues and problems. Assist in external audits pertaining to equipment calibration, validation, and function. Schedule and assist vendors with equipment calibration and maintenance. Assists in the training of any new equipment/ devices. Freezer and refrigerator calibration and maintenance. Atomic clock calibration and maintenance. Support REES System administration, weekly logs, and backups. Perform Emergency Generator Testing. Assist with AED device testing. Salary and Benefits : Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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 *********************************

The Clinical Research Data Scientist is responsible for the data extraction, cleaning, compilation, and analysis of data related to clinical research studies, projects, and publications. Duties and Responsibilities: Management of clinical research data, including: Data pulls/data mining Data cleaning Data and statistical analysis of pulled data from large data sets Preparation of data (charts, tables) for presentation and for publications (abstracts and manuscripts) Additional responsibilities related to the management and coordination of new and existing clinical research projects: may include, but are not limited to, administrative duties, regulatory compliance, clinical operations, and study monitoring. Other duties as assigned Required Skills and Abilities: Proficiency with Advanced Excel Proficiency with SQL and Power BI Proficiency with Microsoft Office Suite products (Word, Excel, PowerPoint, Outlook, etc.) Experience with Data analysis software: SAS, R, Python, etc. Background knowledge in science and/or Biostatistics and its application to clinical data Prior experience with manuscript preparation including preparation of tables, figures, charts Experience in the collection, analysis and presentation of complex clinical data including large data sets from multiple data sources Ability to review literature, read and apply information from literature reviews to CDx's current and future research projects To work under the direction of the Director of Research in the design and implementation of clinical studies. Project Management Must have excellent organizational skills with meticulous attention to detail Strong collaboration and communication skills within and across teams Ability to multi-task and prioritize Ability to function under pressure and meet deadline-oriented project demands as well as manage multiple initiatives Ability to work effectively in a self-guided manner and in an interdisciplinary team environment Critical thinking and problem-solving Ability to adapt workflows to technical and regulatory constraints to facilitate the execution and ongoing success of CDx's clinical studies. Education and Experience: Bachelor's degree in data science, Health Science, Health Care Information, Biostatistics, Computer Science, or related research field. Master's degree preferred. Minimum 2-3 years prior experience with clinical research data analysis and manuscript preparation. Work Environment & Physical Demands: This is a full-time position, based in the Suffern, NY office. Work is performed in an office environment and requires the ability to operate standard office equipment Prolonged periods of sedentary work that requires sitting at a desk and working on a computer 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. We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status or any other status protected under federal, state or local law. We participate in E-Verify.

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

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

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

ASSISTANT CLINICAL RESEARCH COORDINATOR / EQUIPMENT SUPERVISOR Reports to: Clinical Operations Manager or equivalent. Supervises: None Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Qualifications: * Experience: Six months to two years of similar or related experience. * Education: High School diploma/certificate or educational equivalent; or equivalent combination of education, training, and experience; BS/BA preferred. * Minimum Skills: Experience with EMR, MS Word, Excel, MS outlook. * Interpersonal Skills: A significant level of trust and diplomacy is required, in addition to normal courtesy and tact. Work involves extensive personal contact with others and/or is usually of a personal or sensitive nature. Experience: * Must possess a general knowledge of applicable clinical research regulatory requirements; general knowledge of GCP and ICH guidelines is preferred. * Strong computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint. * Strong written and verbal communication skills. * Effective time management and organizational skills. * Attention to detail and accuracy in work. * Knowledge of applicable protocol requirements Specific Responsibilities: * Assists the Clinical Research Coordinator in developing strategies for implementing study procedures in compliance with the study protocol. * Organize and maintain patient research charts and other research documentation. * Conduct patient research visits in conjunction with nursing staff and physician, following written instructions per protocol. * Screen potential research patients for study eligibility and communicate research studies to eligible participants and obtain informed consent. * Interact in a professional manner with pharmaceutical company representatives, physicians, and other staff to obtain and review data. * Accurately update and maintain clinical systems within project timelines; prepare, handle, distribute, file, and archive clinical documentation and reports; review study files periodically for accuracy and completeness; prepare, handle and distribute Clinical Trial Supplies and maintenance of tracking information; track and manage Case Report Forms (CRFs), queries and clinical data flow. * Follow written direction and protocols precisely. * Multi-task for a variety of projects. Assists to determine methods and procedures on new assignments and may supervise the activities of other Clinical Services personnel (e.g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters.) * Ensure that company SOPs and procedures pertaining to equipment maintenance are being followed. * Ensure compliance with all equipment maintenance requirements. * Maintain medical equipment records. * Perform routine and organized inventory of all company equipment. * Assists QA in IQ/OQ/PQ and validation/calibration of new equipment/devices. * Perform medical equipment inspections and preventive maintenance. * Collaborate with project managers/study coordinators in medical equipment rentals/purchases. * Collaborate with IT in the rental/purchase/installation and maintenance of any software/hardware that is equipment related. * Ensure parts/replacements are readily available without overstocking. * Monitor the effective use of existing equipment and determine the need for additional equipment. * Provide basic training to staff on how to maintain/operate equipment in an optimal manner. * Assist Frontage staff in solving day-to-day equipment maintenance issues and problems. * Assist in external audits pertaining to equipment calibration, validation, and function. * Schedule and assist vendors with equipment calibration and maintenance. * Assists in the training of any new equipment/ devices. * Freezer and refrigerator calibration and maintenance. * Atomic clock calibration and maintenance. * Support REES System administration, weekly logs, and backups. * Perform Emergency Generator Testing. * Assist with AED device testing. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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 *********************************

Join our dynamic pulmonology research team as a Research Coordinator, where you will contribute to cutting-edge studies in cystic fibrosis, asthma, COVID, and various other pulmonary diseases. We are seeking a dedicated and organized individual to facilitate and coordinate research activities, ensuring the success of our diverse projects. This role offers ample opportunities for professional growth and development within a supportive and affable team environment. Responsibilities Coordinate all aspects of research projects within the Pulmonology Research Center, from participant recruitment to data analysis and dissemination of findings. Collaborate closely with principal investigators, clinicians, and research staff to develop and implement research protocols, timelines, and procedures. Ensure compliance with regulatory requirements by maintaining accurate documentation of research activities. Assist in the preparation of grant proposals, research reports, and scholarly publications. Coordinate and participate in meetings, conferences, and presentations related to research activities. Qualifications Education requirement: Bachelor's degree in a related field preferred. Technical/computer skills: Proficiency in Microsoft Office and research management software. Prior experience: 2+ years in clinical research coordination or related field preferred. Other skills/requirements Demonstrated experience in clinical research coordination or related roles, with a strong understanding of research. methodologies and regulatory requirements. Physical demands: Office work demands (desk work, walking short distances between offices, standing). Environmental demands: Exposure to research subjects who may be actively ill. Research methodologies may include procedures with some mild level of risk, such as phlebotomy. Minimum Salary USD $40,000.00/Yr. Maximum Salary USD $50,000.00/Yr.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments. • Participate in development of protocol, case report form, CRF guidelines and other study documents. • Prepare and/or review regulatory documents (e.g. ICF), contracts, requests for proposal. • Ensure the training of CROs/investigators on protocol, regulatory, Client SOPs and data issues. • Reviews and approves monitoring reports and ensures tracking of ongoing site issues. • Minimum of college degree in a relevant discipline. Qualifications • Bachelors degree in relevant scientific discipline preferred. • 1-2 years experience in pharmaceutical industry. Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter