Clinical research coordinator jobs in Millcreek, PA

Title: Clinical Engineering Project Manager Duration: 3-4 months Precise. Reliable. Powerful. Join a team as innovative as the technology we manage. Are you a Clinical Engineer or lead biomedical/imaging equipment technology professional who has strong project management experience/training? Here's your opportunity to use analytic skills to manage and make recommendations for equipment replacement planning and forecasting. What You'll Do Coordinate the implementation of a defined, short-term project or sub-set of projects (less than one year) within set organizational procedures and standards. Responsible for meeting sub-set objectives within quality, time, and budget targets, and for managing associated risks. Typical knowledge and experience of the technical area being managed and an awareness of the business issues. What You Bring Background in clinical engineering with medical devices and project management, specific to equipment replacement planning & forecasting and contracts analysis; Clinical Engineering degree or equivalent experience, 3-5 years in a healthcare setting. This position will manage the capital process of medical equipment from start to finish. Experience providing analysis, consultation, and research to establish project timelines and deliverables; Participated in cross functional project teams to determine the most appropriate equipment service, purchases, and agreements; Experience in managing projects, being well organized, self-motivated, and have excellent communication skills.

Note : Only One Round Interview. The Field Clinical Coordinator plays a key role in supporting healthcare professionals, primarily nurses, to ensure the effective utilization of clinical systems and devices. This position involves facilitating seamless device installations, guiding staff on proper usage and best practices, and providing on-site support for technical troubleshooting and operational issues Job Description: Training & Assistance for Nurses & Care Teams Deliver hands-on training to nurses and caregivers on device operation, maintenance, and interpretation of readings Provide on-site and remote support to address common device and system issues Ensure compliance with facility protocols and company guidelines during device use Coordinate and facilitate telehealth assessments in collaboration with Nurse Practitioners (NPs) Support nursing teams in performing basic patient reviews for stable patients Maintain strong clinical understanding, communication, and bedside interaction skills On-Site Troubleshooting & Technical Support Respond promptly to service requests to resolve device malfunctions or connectivity issues Diagnose and address minor hardware or software problems, escalating complex cases to the technical support team Replace or maintain faulty devices to ensure uninterrupted clinical operations Ensure all necessary firmware updates are applied to keep devices performing optimally Device Installation & Setup Coordination with the Installation Team to deploy RPM devices (e.g., sensors, monitors, software systems, etc) at healthcare facilities Ensuring proper device calibration, pairing, and network connectivity Performing initial setup tests to verify full functionality before leaving the site Compliance & Safety Adherence Compliance with HIPAA regulations and company policies to ensure patient data privacy. Adherence to safety protocols when handling medical-grade electronic devices. Verification that devices meet hospital infection control standards before and after installation. Maintenance of relevant certifications (e.g., CNA, Paramedic, MA) as required for compliance and safety. Documentation & Reporting Log all installation, troubleshooting, and repair activities in the system. Timely reporting of recurring issues to engineering or product teams for improvement. Maintenance of detailed service logs, customer interaction records, and resolution statuses. Inventory & Maintenance Management Maintain an inventory of devices, replacement devices, and peripherals. Track device deployment, retrievals, and replacements in the system. Ensure proper storage and transportation of devices to prevent damage. 7. Communication & Coordination Coordination with clinical, install and technical support, engineering, product and logistics teams to ensure seamless service execution. Providing actionable feedback to product development teams based on field observations. Relaying customer complaints and suggestions to higher management for resolution and process improvement. Certifications & Skills: Certifications such as CNA, Paramedic, or Medical Assistant (MA) - At least 1 is required. Valid driver's license and willingness to travel frequently. Experience: Minimum 2-3 years' experience in clinical coordination, medical device installation, or healthcare technology support. Experience working in healthcare environments, preferably skilled nursing facilities. Skills & Competencies: This role requires frequent travel within assigned regions. Strong clinical knowledge and familiarity with healthcare workflows and medical devices. Excellent communication and interpersonal skills. Ability to train and guide clinical staff effectively. Strong troubleshooting and technical problem-solving skills. Attention to detail and ability to maintain accurate records. Ability to work independently in the field while managing multiple priorities

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Operations Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America Job Description: About Surgery Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Clinical Research Associate I. OVERALL RESPONSIBILITIES: On behalf of Clinical Affairs, Robotics and Digital Solutions, within Johnson & Johnson MedTech Surgery, the Clinical Research Associate I (CRA I) serves as the primary contact point between the Sponsor and the Investigational Site. The CRA I responsibilities include supporting the clinical trial team in study operations activities. The CRA I may be assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulations and guidelines from study start-up through site closure. Key Job Activities: Principal Clinical Study Site Management Tasks Support clinical trial operational activities such as device management and study budget tracking. May act as primary local company contact for assigned sites for specific trials. May participate in site feasibility and/or pre-trial site assessment visits. Attend/participate in investigator meetings as needed. Partners with the clinical trial team to execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. May ensure site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Work in close collaboration with Clinical Research Manager for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe. Develops monitoring skills to ensure site staff complete data entry and resolve queries within expected timelines, and accuracy, validity and completeness of data collected at trial sites. Develops monitoring skills to ensure that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents. Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management. If conducting monitoring visits, fully document trial-related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. Review study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. Collaborate with the Clinical Research Manager for documenting and communicating site/study progress and issues to trial central team. Attend regularly scheduled team meetings and trainings. Comply with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. May prepare trial sites for close out, conduct final close out visit. Establish and maintain good working relationships with internal and external stakeholders, investigators, trial coordinators and other site staff. May contribute to process improvement and training. Lead and/or participate in special initiatives as assigned. May assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”. This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. May collaborate with contractors/vendors, and company personnel as needed. Administrative Tasks: CRA I knows, understands, incorporates, and complies with all applicable laws and regulations relating to J&J business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct. May be asked to provide additional support to Clinical Affairs, Robotics and Digital Solutions staff, as needed. Job Qualifications: Education A Bachelor's Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science. Experience Bachelor's degree with at least 3 years of relevant experience; Master's or PhD/MD/PharmD with at least 1 year of relevant experience. Previous clinical research experience required. Previous medical device monitoring or equivalent experience required. Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products. Relevant industry certifications preferred (e.g., CCRA, RAC, CDE). Knowledge Requires experience and knowledge working with computer systems (Microsoft Office - Excel, Word, PowerPoint and Outlook). Additional Requirements: Strong computer skills in appropriate software and related company clinical systems Proficient in speaking and writing the country language, English Presentation and influencing skills Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines). Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required. A valid Driver's License issued in one of the 50 United States and a good driving record is required. Additional Information: The expected base pay range for this position is $76,000 - $121,900/ annually . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: o Vacation -120 hours per calendar year o Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year o Holiday pay, including Floating Holidays -13 days per calendar year o Work, Personal and Family Time - up to 40 hours per calendar year o Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child o Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member o Caregiver Leave - 10 days o Volunteer Leave - 4 days o Military Spouse Time-Off - 80 hours Additional information can be found through the link below. ********************************************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. #LI-Onsite Required Skills: Preferred Skills: Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time Management The anticipated base pay range for this position is : 76000-121,900 Additional Description for Pay Transparency:

Cellectis' Clinical Sciences (CS) organization is seeking a highly motivated and experienced clinical Research Scientist to support the both the development and execution of our innovative proprietary UCART allogeneic CART cell therapies programs. The Director, Clinical Research Scientist participates in design and implementation of the development strategy and supports the Clinical Science Physicians with various deliverables necessary for effective and efficient planning and execution of their assigned program. Additionally, the successful candidate in this role would also be responsible for working closely with the Clinical Operations Team to support the development of clinical development processes, templates and potentially training and management of junior clinical research scientists. Job Responsibilities Supports the clinical development of assigned programs and participates and supports the design and implementation of the development strategy Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA) The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience May co-lead study team meetings in partnership with Clinical Operations study lead Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums, act as primary point-of-contact for clinical study or program for clinical science related activities, and providing clinical science inputs into study safety reporting. Clinical Scientists are likely to have regular external interactions with a variety of internal and external partners and stakeholders, such as cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups. They may also, alongside the Clinical Sciences Physician, participate in external interactions with health authorities (HAs) Provides strategic clinical science support for assigned studies and programs Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required May author and/or review clinical narratives in conjunction with pharmacovigilance in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion in concert with Clinical Science Physicians In concert with Clinical Sciences Physicians provide clinical contributions to internal documents and presentations including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts) As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists Where applicable, may manage one or more direct reports and is, in such instances responsible for hiring, training, developing, and retaining talent on his/her staff. As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment Core Competencies Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally Outstanding written communication skills Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points Comfortable working in fast paced entrepreneurial environment Ability to travel up to 20% Education and Experience Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred) Minimum of 5 years pharma/biotech industry experience in clinical development in oncology/hematology clinical trials experience in CAR T-cell therapy is preferred Experience in data review, data cleaning, managing and interpreting clinical trials results as well as exposure to writing protocols Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research Physical Requirements In office 4 days per week, required Sedentary, desk position Salary Range $175,000-225,000 (final salary is dependent on candidate's experience and credentials)

CRA II OR Senior CRA (home-based in the U.S.) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license #LI-MM2 #LI-Remote What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

CRA II OR Senior CRA (home-based in the U.S.) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. **What you will be doing** + Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. + Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. + Collaborating with investigators and site staff to facilitate smooth study conduct. + Performing data review and resolution of queries to maintain high-quality clinical data. + Contributing to the preparation and review of study documentation, including protocols and clinical study reports **Your profile** + Bachelor's degree in a scientific or healthcare-related field. + Minimum of 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate. + In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. + Strong organizational and communication skills, with attention to detail. + Ability to work independently and collaboratively in a fast-paced environment. + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license \#LI-MM2 \#LI-Remote **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

Job Summary: Coordinate various research trials for the Institute for Global Health, including early or late phase FDA-regulated trials, and ensure compliance with federal guidelines. Interact and correspond with clinicians, sponsors, cooperative groups, Upstate's Institutional Review Board and regulatory agencies. Enroll, register and screen patients for clinical research trials; collect and submit clinical trial patient data. Perform various administrative duties, which may include proper collection and shipment of lab samples; billing support; maintenance of clinical research study supplies and drug accountability. Minimum Qualifications: Bachelor's degree and 3 years related experience or equivalent combination of education and experience, experience with clinical research protocols, knowledge of medical terminology, computer skills, and good written/oral communication and organizational skills required. Preferred Qualifications: SOCRA or ACRP certification preferred. Work Days: Monday - Friday, Days with occasional weekends Message to Applicants: Recruitment Office: Human Resources

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, PTO and 401K

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. In the performance of their respective tasks and duties all employees are expected to conform to the following: * Perform quality work within deadlines with or without direct supervision. • Interact professionally with other employees, customers and suppliers. • Work effectively as a team contributor on all assignments. * Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations. Position purpose The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Director and Clinical Principal Investigator (PI). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Responsibilities/Duties/Functions/Tasks: * Communicate study requirements to all individuals involved in the study. • Develop and implement recruitment strategies in accordance with Impact Research and IRB requirements and approvals. * Screen subjects for eligibility using protocol specific inclusion and exclusion criteria. • Entry of participant information and study visit procedures into the Clinical Trial Management System to ensure billing to appropriate funding source. * Maintains adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol and/or Impact ResearchPolicy on Investigational Drug/Device Accountability. * Complete study documentation and maintenance of study files in accordance with sponsor requirements and Impact Research policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. * Maintains effective and ongoing communication with sponsor, research participants, Director and PI during the course of the study. * Manage the day to day activities of the study including problem solving, communication and protocol management. * Collects and reports ongoing patient recruitment/ enrollment metrics to Director and PI. * Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer. * Protects the rights and welfare of all human research participants involved in research in accordance with Federal regulations * Cooperates with Impact Research compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office. * Other duties as assigned. Qualifications Education: High school diploma/GED certificate required. Associates degree from an accredited university preferred. Experience: Minimum 4 or more years of clinical research experience. Other Requirements: CRC certification preferred. Performance Requirements: * Knowledge of grammar, spelling, and punctuation. * Knowledge of purchasing, budgeting, and inventory control. * Skill in taking and transcribing dictation and operating office equipment. • Skill in answering the phone and responding to questions. * Skill in time management, prioritization, and multitasking. * Skill in writing and communicating effectively. * Ability to work under pressure, communicate and present information. • Ability to read, interpret, and apply clinic policies and procedures. * Ability to identify problems, recommend solutions, organize and analyze information. • Ability to multi-task, establish priorities, and coordinate work activities. • Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software. * Must be able to lift up to 25 lbs. * Must be able to travel and MVR Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc. Work Environment: Position is in a well-lighted medical office environment. Occasional evening and weekend work. Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines. At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

* Job Type: Support Staff - Non-Union * Regular/Temporary: Regular * Hours Per Week: 20 * Salary Range: $22.85 - $24.04 per hour The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. Position Summary The New York Obesity Research Center, within the Division of Endocrinology, is seeking a Clinical Research Associate to support the technical aspects of a clinical trial focused on obesity and type 2 diabetes. The study involves participants of diverse backgrounds and age groups. The incumbent will be responsible for biospecimen collection, processing, and shipment to the central laboratory, and will assist with study visits at one of the clinical sites participating in a large, ongoing multicenter clinical trial. Responsibilities * Adhere to all Columbia University clinical research regulations, including COVID-19 safety protocols * Maintain comprehensive knowledge of protocol procedures related to biospecimen processing * Complete training and certification in biospecimen processing per study protocol * Prepare for study visits, including photocopying questionnaires and organizing supplies * Support participant retention efforts (e.g., mailing letters, birthday cards, appreciation gifts, and occasional phone calls) * Assist with calibration and standardization of study equipment (e.g., automatic blood pressure cuffs, stadiometers, scales) * Manage study supplies, including proper storage and maintenance of inventory logs * Perform blood and urine biospecimen collection, processing, and shipment according to strict protocol * Escort participants to offsite imaging centers (e.g., brain MRI and PET scan facilities) * Assist with various aspects of study visits, including providing snacks and meals for participants * Perform related duties as assigned Minimum Qualifications * Bachelor's degree or equivalent in education, training and/or experience * Minimum of five (5) years of phlebotomy experience in a research setting * Strong communication skills and ability to interact with a diverse participant population * Bilingual in Spanish and English * Proficiency in Microsoft Word and Excel * Highly organized and self-motivated * Ability to prioritize and manage multiple tasks while meeting deadlines Preferred Qualifications * Experience in a clinical research environment, with knowledge of HIPAA and Rascal systems Other Requirements * Participation in medical surveillance program * Contact with human subjects * Potential bloodborne pathogen exposure * Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.

Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description • This role is to provide comprehensive project coordination support for reducing the risk of phishing by supporting Info Protect Culture Change Behavioral Research Project • Clinical experience is helpful but not mandatory • Provide operational support and project administration for the Info Protect Culture Change Behavioral Research Project. The role entails coordinating clinical project development and implementation, project monitoring and control, risk management, and project governance. Efforts must adhere to principles of transparency across the programs and enable comparability with other efforts. Incumbent will serve as an operational 'single point of contact'; Collaborate with internal and external partners and vendors; Develop and implement project activities as assigned by the project manager; Track study budget spend and report monthly; Review and reconcile invoices for payment approval; and create and maintain project documentation including project plans, meeting minutes and agenda, project risk and decision logs, and other documents needed for project execution. Qualifications • Experience running clinical trials or University studies not required but recommended. • Project Admin/Coordinator - Level of knowledge/expertise: Extensive capability and expert understanding Job Profile: project admin/coordinator Provide administrative project planning support to Programme/Project Manager as required and provide plans converted into various formats Convert the output of the PM meeting into a monthly report and maintain the ISAC and FPAC project tracking tools Provide support to the PMO as requested. • The Information Protection programme at multi-year global programme to protect information. Within the programme, there is an Information Protection Culture work stream with the goal to fundamentally drive worldwide employee culture change for protecting information through education and awareness.

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge. For more information, go to med.nyu.edu , and interact with us on LinkedIn , Glassdoor , Indeed , Facebook , Twitter and Instagram . Position Summary: We have an exciting opportunity to join our team as a Research Associate. In this role, the successful candidate is responsible for conducting independent basic science experimentation based on research conducted in the assigned laboratory under the mentorship of a senior scientist. Individual is expected to seek to build a portfolio of research accomplishments in preparation for acquiring a higher degree in biomedical research or medicine. Additional Position Specific Responsibilities: This role involves clinical research data collection, interaction with human subjects, and the maintenance of clinical research date data - this role does not include bench science research Performs in-person and over-the-phone participant recruitment. Performs data collection over the phone, by email or in dialysis centers, in-patient, and out-patient settings (or other clinical settings). Performs in-person and over-the-phone follow-up of participants who are enrolled in clinical trials and cohort studies. Conducts chart abstractions to ascertain clinical data Administers behavioral, exercise and other interventions in clinical settings. Reports enrollment, follow-up, and retention rates for clinical trials and cohort studies. Prepares and maintains Standard Operating Procedures(SOPs) for clinical trials and cohort studies. Performs specimen processing and storage. Maintains study databases by entering, cleaning, and verifying data for accuracy and completeness. Coordinates communication between study sites, clinical staff, and research team members to ensure protocol adherence and timely data collection. Participates in study team meetings and contributes to protocol development, recruitment strategies, regulatory submissions, and process improvement discussions. Assists in the development and pilot testing of study instruments, surveys, and data collection tools. Prepares study materials such as recruitment flyers, participant packets, and consent forms. Schedules and documents study visits, maintaining detailed logs for tracking participant flow and study progress. Assists in the preparation of reports, abstracts, posters, and manuscripts for presentations and publications. Ensures compliance with Good Clinical Practice (GCP) and institutional policies related to participant safety, confidentiality, and data management. Monitors study supplies and coordinates with laboratory and clinical teams to ensure proper inventory and equipment maintenance. Assists with quality assurance activities, including source document verification and internal audits. Supports grant and budget tracking, including study reimbursements and invoicing for multicenter projects. After a period of time working with the research team, the candidate will be expected to train newly hired Research Associates, graduate students, and postdoctoral fellows in the study design, data collection, blood processing technique, and other aspects of the research. Job Responsibilities: After a period of time working in the laboratory, the candidate will be expected to train graduate students and post-doctoral fellows in experimental design, technique and performance. Generates hypotheses and designs and performs experiments to test them. Executes multiple experiments simultaneously over time independently. Records all experimental findings in a laboratory notebook, analyze and interpret experimental findings. Based on results, independently suggests and tests modifications to protocols. Prepares figures and diagrams for presentations and publications. Communicates results and collaborates with other professionals in the lab. Demonstrates a significant level of intellectual input into the design of the project. Presents findings at lab meeting, responds to challenges, and participates in exchanges of ideas to advance the science. Reads and understands relevant scientific literature. Contributes to the preparation of articles on research outcomes and progress and to the submission of same for publication. Participates in the editing and proofing of grant proposals, annual grant reports, and manuscripts for publication and recommends modifications to the Principal Investigator. Additional Position Specific Responsibilities: This role involves clinical research data collection, interaction with human subjects, and the maintenance of clinical research date data - this role does not include bench science research Performs in-person and over-the-phone participant recruitment. Performs data collection over the phone, by email or in dialysis centers, in-patient, and out-patient settings (or other clinical settings). Performs in-person and over-the-phone follow-up of participants who are enrolled in clinical trials and cohort studies. Conducts chart abstractions to ascertain clinical data Administers behavioral, exercise and other interventions in clinical settings. Reports enrollment, follow-up, and retention rates for clinical trials and cohort studies. Prepares and maintains Standard Operating Procedures(SOPs) for clinical trials and cohort studies. Performs specimen processing and storage. Maintains study databases by entering, cleaning, and verifying data for accuracy and completeness. Coordinates communication between study sites, clinical staff, and research team members to ensure protocol adherence and timely data collection. Participates in study team meetings and contributes to protocol development, recruitment strategies, regulatory submissions, and process improvement discussions. Assists in the development and pilot testing of study instruments, surveys, and data collection tools. Prepares study materials such as recruitment flyers, participant packets, and consent forms. Schedules and documents study visits, maintaining detailed logs for tracking participant flow and study progress. Assists in the preparation of reports, abstracts, posters, and manuscripts for presentations and publications. Ensures compliance with Good Clinical Practice (GCP) and institutional policies related to participant safety, confidentiality, and data management. Monitors study supplies and coordinates with laboratory and clinical teams to ensure proper inventory and equipment maintenance. Assists with quality assurance activities, including source document verification and internal audits. Supports grant and budget tracking, including study reimbursements and invoicing for multicenter projects. After a period of time working with the research team, the candidate will be expected to train newly hired Research Associates, graduate students, and postdoctoral fellows in the study design, data collection, blood processing technique, and other aspects of the research. Minimum Qualifications: To qualify you must have a College graduate with a B.S. or B.A. in Biomedical or Physical Sciences. A minimum commitment of two years is required and placement in position may not exceed three years. Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family. NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online. View Know Your Rights: Workplace discrimination is illegal. NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $47,033.89 - $63,600.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits. To view the Pay Transparency Notice, please click here

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.

**Penn State Health** - **Hershey Medical Center** **Work Type:** Full Time **FTE:** 1.00 **Shift:** Day **Hours:** 8-hour shifts **Recruiter Contact:** Denisse M. Rosado at ******************************** (MAILTO://********************************) **SUMMARY OF POSITION:** Responsible for the facilitation, coordination and implementation of clinical research protocols under physician investigator guidance and delegation, including liaison with faculty and external sponsors/agencies, patient management and education, budget review and quality management. **MINIMUM QUALIFICATIONS:** Bachelor's degree in Nursing or Master's degree in Nursing required. 2 years clinical experience as an RN required. 2 years clinical research experience required. Currently licensed to practice as a Registered Nurse by state of employment or holds a multistate RN license through the interstate Nurse Licensure Compact. Research certification (SoCRA or ACRP) required. If not certified, must be willing to pursue and obtain certification within six months. **WHY PENN STATE HEALTH?** Penn State Health offers exceptional opportunities to learn and grow, exposure to a wide patient population, and the ability to provide individualized, innovative, and specialized care to patients in the community. **Penn State Health offers an exceptional benefits package including medical, dental and vision with no waiting period as well as a Total Rewards Program that highlights a few of the many additional offerings below:** + **_Be Well_** with Employee Wellness Programs, and Fitness Discounts (University Fitness Center, Peloton). + **_Be Balanced_** with Generous Paid Time Off, Personal Time, and Paid Parental Leave. + **_Be Secured_** with Retirement, Extended Illness Bank, Life Insurance, and Identity Theft Protection. + **_Be Rewarded_** with Competitive Pay, Tuition Reimbursement, and PAWS UP employee recognition program. + **_Be Supported_** by the HR Solution Center, Learning and Organizational Development and Virtual Benefits Orientation, Employee Exclusive Concierge Service for scheduling. **WHY PENN STATE HEALTH MILTON HERSHEY MEDICAL CENTER?** Penn State Hershey Medical Center is Central Pennsylvania's only Academic Medical Center, Level 1 Regional Adult and Pediatric Trauma Center, and Tertiary Care Provider. As a four-time Magnet-designated hospital, Hershey Medical Center values the hard work and dedication that our employees exhibit every day. Through our core values of Respect, Integrity, Teamwork, and Excellence, our employees are a team committed to compassionate care for our diverse patient population, our community and each other. As a valued team member, we promote continued professional development, specialty certification, continuing education, and career growth. **YOU TAKE CARE OF THEM. WE'LL TAKE CARE OF YOU. State-of-the-art equipment, endless learning, and a culture of excellence - that's Penn State Health. But what makes our healthcare award-winning? That's all you.** _This job posting is a general outline of duties performed and is not to be misconstrued as encompassing all duties performed within the position. Eligibility for shift differential pay based on the terms outlined in company policy or union contract._ _All individuals (including current employees) selected for a position will undergo a background check appropriate for the position's responsibilities._ _Penn State Health is an Equal Opportunity Employer and does not discriminate on the basis of any protected class including disability or veteran status. Penn State Health's policies and objectives are in direct compliance with all federal and state constitutional provisions, laws, regulations, guidelines, and executive orders that prohibit or outlaw discrimination._ **Union:** Non Bargained **Position** Coordinator Clinical Research II - DAY SHIFT - Clinical Heart and Vascular Cardio Research **Location** US:PA: Hershey | Nursing | Full Time **Req ID** 68507

Meadville Medical Center is seeking an experienced Respiratory Therapist to serve as Clinical Coordinator. The position is full-time (1.0) day shift with on-call shifts. Will be dedicated to ensuring compliance with clinical policies, procedures using the American Association of Respiratory Care (AARC) Guidelines and other regulatory standards. Will be able to provide oversite of policies/procedures. Coordinating staff assignments. Will assume on call responsibilities 8-10 shifts per schedule. Will work collaboratively with the respiratory therapy manager, the vice president of rehabilitation and outpatient services, and medical director of respiratory services. Will support the staff clinically and to develop quality processes. Hold daily huddles with all shifts. Provide, promote, and enhance community outreach programs including, but not limited to, pulmonary support groups and smoke/vaping cessation. Serve as a mentor/educator to staff- provide RT staff, at regular interval, educational content that will broaden the team's knowledge and skills while assuring institutional educational and competency requirements are met. Assists with new hires, orientation, schedules, multi-rater for evaluations, monthly staff meetings, and counsels. Act on identified problems and/or situations and provide feedback with appropriate documentation. Promotes an environment in which the patient care team can work cooperatively toward objectives. Performs completion of monthly Quality Assurance and Improvement projects, in addition to chart audits. Provide written documentation of staff education following quality audits when deficits occur. Coordinates and assures all clinical staff has documentation of current BLS. If applicable ACLS, PALS, and NRP. Assist with proficiency testing and competency assessments for the blood gas lab, in accordance with CAP guidelines. Will maintain staff respiratory therapy functions in a leadership role. MINIMUM EDUCATION, KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED Associate's degree in Respiratory Therapy required, Bachelor's of Science degree highly preferred. Registered Respiratory Therapist credential required. A minimum 3 years of high acuity Respiratory Therapy experience required. Leadership/educational experience required. Current PA License and BLS/PALS/ACLS (PALS & ACLS maybe obtained within 3 months of hire) Requires critical thinking skills, decisive judgment, leadership skills. Must be able to work in a dynamic and rapidly changing environment and take appropriate actions. WORKING CONDITIONS Normal patient care environment with little exposure to excessive noise, dust, and temperature change. Subject to certain distasteful patient care activities; exposure to communicable diseases. May be exposed to potential hazards such as chemical waste, body waste, fluids, and other possible infectious material. May be scheduled overtime, weekend and or holiday hours. DISCLOSURE MMC commits to review, under the intent of this standard, and in coordination with medical professional opinion's and physical demands job analysis performed by certified professionals, an individual's ability to be reasonably accommodated within the role they are responsible and qualified to perform. MMC is committed to complying with the Americans with Disabilities Act (“ADA”) and providing equal opportunity employment for qualified persons with disabilities. All employment practices and activities are conducted on a nondiscriminatory basis. Meadville Medical Center will follow any state or local law that provides individuals with disabilities greater protection that the ADA. Every effort has been made to make your job description as complete as possible. However, this in no way states or implies that these are the only duties you will be required to perform. The omission of specific tasks does not exclude them from the position if the task is similar, related, or is a logical assignment to the position, or is imperative for patient care and to meet emergency situations.

Clinical Research Associate - Remote - US ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license #LI-Remote #LI-AR2 What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

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, PTO and 401K

This position is responsible for the coordination of ALS clinical research studies. Performance of regulatory tasks including IRB and sponsor/CRO regulatory correspondence. Communication with IRBs, sponsors, and protocol-related Upstate Departments. Pre-screen, Screen, and enroll research participants in outpatient ALS clinical trials. Additional duties include but are not limited to: process and ship lab samples, schedule and conduct follow up research appointments for clinical trial participants, data collection and entry into paper and electronic databases, maintenance of clinical research supply inventory, processing clinical trial billing and payments, and the administration of study questionnaires and assessments. Minimum Qualifications: Bachelor's degree and two years of related experience or an equivalent combination of education and experience. Working knowledge of medical terminology, basic computer skills and excellent written/oral communication and organizational skills. Preferred Qualifications: Prior experience with clinical research protocols and/or experience with coordinating ALS clinical trials. ACRP and/or SOCRA certification. Work Days: Mon - Fri - Daytime hours Message to Applicants: Salary Range:$60,000-$65,000 Recruitment Office: Human Resources

The Clinical Research Associate I (CRA I) will join a team of experienced associates and manage various research trials, including first in human through phase 3 trials. The role will be expected to manage 2-3 studies simultaneously. The will ensure compliance with FDA guidelines and follow GCP for all managed studies. The CRA I will interact daily with clinicians, sponsors, IRB, regulatory agencies and other research professionals. This is a subject / patient facing role, the candidate needs the ability to communicate directly with study volunteers, collecting detailed clinical information and communicating that to the study team. The CRA I will be responsible for all aspects of the trial conduct including; IRB submission, regulatory documents, training staff, overseeing enrollment of appropriate study subjects, creation and completion of source documents, database entry and query resolution. The CRA I will be the point person on assigned clinical trials and flexible availability is expected. This role is also the key contact for study sponsors / collaborators; therefore, a high level of professionalism and communication skills are required. This role will be expected to prepare for a national certification (SoCRA) exam after 2 years of full-time employment. Minimum Qualifications: A bachelors degree and 2 years of related experiance or a equivalent combination of education and experiance. Ability to function in a professional environment, that requires a high attention to detail and exemplary. Preferred Qualifications: Clinical skills including phlebotomy, ability to take and record accurate vital signs, obtain EKG tracings, and general medical terminology will be preferred. Work Days: Monday - Friday 8am - 4:30pm. Occasional evenings and weekends Message to Applicants: Salary range-$60,406-$65,000 Recruitment Office: Human Resources