Clinical research associate jobs in Chambersburg, PA - 21 jobs

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. **Discover Impactful Work:** **We are seeking a Clinical Research Coordinator III (Registered Nurse)** to support our government customer on-site in **_Silver Spring, Maryland_** . This is a per diem, non benefited position. **Availability neede** **d (** **6:00 am - 10: 00 am).** + Relocation assistance is NOT provided for this role. + Must be a U.S. citizen. + Must be able to pass a comprehensive background check, which includes a drug screening and a physical. + Required to be a Registered Nurse licensed to practice in the state of Maryland. **A day in the Life:** + Organizes and prioritizes all activities associated with conducting phase 1, 2, and 3 clinical and operational research studies within a military clinic setting. + Reviews and understands research protocols, ensuring applicable regulations and guidelines are followed. + Organizes research information for clinical projects + Selects and observes subjects and assists with data analysis and reporting. + Oversees experiment scheduling and collection of data. + Participates in source document and study document design, writing SSP, materials planning, visit schedule creation, etc. + Enters required data routinely on CRFs and audit records for accuracy, resolve discrepancies, and correct as necessary. + Maintains study/test article or investigational product accountability and administration. + Monitors study data collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally required guidance. + Relies on experience and judgment to plan and accomplish goals. Works under general supervision and performs a variety of tasks. **Keys to Success:** **Required Education** + Required to be a Registered Nurse licensed to practice in the state of Maryland, who is skilled and qualified in nursing procedures to include, but not limited to the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314. + Basic Life Support (BLS -CPR/AED) certification. **Required Experience and Skills:** + Five (5) years of experience in clinical research coordination, with expertise in FDA-regulated trials. + Experience utilizing clinical trial management systems and databases (e.g., REDcap and Inform). + Must be able to work both independently and in a team setting following a brief period of specific technical training. + Must have excellent communication, organization, and prioritization skills. + Ability to establish and maintain effective working relationships with coworkers, managers and customers. + Maintenance of Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). **Desired Experience and Skills** + Advanced Cardiac Life Support (ACLS) certification encouraged. + Certification in clinical research (e.g., CCRP or CCRA) is preferred. + Commission for Case Manager Certification (CCMC) certification preferred. **Compensation and Benefits** The salary pay range estimated for this position CRA (Level II) based in Maryland is $38.46-$44.23. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: + A choice of national medical and dental plans, and a national vision plan, including health incentive programs + Employee assistance and family support programs, including commuter benefits and tuition reimbursement + At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy + Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan + Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: ***************************************************** Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Senior CRA / CRA II - Home-Based, United States 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-KC2 #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

**Req ID:** RQ210393 **Type of Requisition:** Regular **Clearance Level Must Be Able to Obtain:** None **Public Trust/Other Required:** NACLC (T3) **Job Family:** Ancillary Health **Skills:** Clinical Research,Data Compilation,Research Protocols **Experience:** 4 + years of related experience **US Citizenship Required:** Yes **Job Description:** **GDIT's Military Health team is hiring a Clinical Research Monitor to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.** **The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.** **The CRA will provide clinical trial monitoring to ensure all sponsor required trial monitoring is conducted and all deliverables are provided according to 21 CFR 312 and ICH.** **This is a hybrid position and will report onsite 2 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance.** **HOW YOU WILL MAKE AN IMPACT:** **Develop a Clinical Monitoring Plan and monitor single site and multicenter clinical studies both inside and outside the continental United States; when required, conduct centralized monitoring activities.** **Remote review of electronic source documents, electronic Case Report Forms (CRFs), trends, and metrics in order to identify and mitigate safety and data quality risk issue(s), prepare Clinical Monitoring Reports and file in the sponsor's regulatory file. The monitoring reports shall include the date of activities, description of the activities, and any findings from the activities-Prepare protocol deviations and violation and non-compliance reports** **Provide remote evaluation of the study data, carried out by a team including central monitors, medical reviewers at a location other than the sites at which the clinical investigation is being conducted and annotate in monitoring reports for the sponsor's regulatory file.** **Prepare/review calibration and maintenance records, which are records kept at the clinical site that document the calibration and maintenance of all applicable equipment utilized during the execution of the clinical trial including laboratory equipment, and ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor's regulatory file.** **Prepare and/or review shipment records, which include shipping documentation for investigation products, biological samples, and if applicable, other study supplies provided to the clinical sites.** **Prepare and/or review laboratory sample analysis reports** **WHAT YOU'LL NEED TO SUCCEED:** **Bachelors degree, 4+ year's experience supporting clinical research** **Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), prepare Clinical Monitoring Reports and file in the sponsor's regulatory file.** **Experience providing remote evaluation of the study data** **Experience preparing/reviewing calibration and maintenance records to ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor's regulatory file.** **Experience preparing and/or reviewing shipment records, documentation for investigation products, biological samples, and other study supplies provided to the clinical sites.** **Must be a US Citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.** **WHAT GDIT CAN OFFER YOU:** **Challenging work that makes a real impact on the world around you** **Internal mobility team dedicated to helping you own your career** **401K with company match** **Diverse, highly collaborative teams** **Professional development, education assistance, certification and training opportunities** **\#GDITHealth** **\#militaryhealth** **\#GDITLabScienceJobs** **\#GDITFedHealthJobs** The likely salary range for this position is $73,965 - $80,500. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most. We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology. Join our Talent Community to stay up to date on our career opportunities and events at ******************** Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans

is 100% onsite in Hagerstown, MD Make a meaningful impact in advancing clinical research at Meritus Health. Meritus Health is seeking a highly skilled and motivated Clinical Research Specialist to support the planning, coordination, and daily operations of clinical research trials across our health system. In this vital role, you'll work directly with the Associate Dean of Research, Principal Investigators, sponsors, and regulatory agencies to ensure that every study is conducted with excellence, accuracy, and integrity. What You Will Do As a Clinical Research Specialist, you will: Lead & Support Clinical Research Activities Assist with the development, implementation, and evaluation of clinical practices for sponsored and Meritus-initiated clinical trials. Ensure the ethical conduct of research and compliance with all regulatory standards (IRB, FDA, GCP). Manage Regulatory Compliance Prepare and maintain submissions for federal, state, and local regulatory bodies, including Institutional Review Boards. Develop and oversee effective systems for required reporting and documentation. Execute Research Protocols Follow clinical trial protocols in alignment with Good Clinical Practice (GCP). Support ongoing quality assurance and quality control processes. Drive Research Growth Identify new research opportunities that align with our system's resources and population. Support the expansion and development of investigator-initiated and sponsored research programs. Engage Participants & the Community Assist in participant recruitment and enrollment. Promote research initiatives to providers, community members, payors, and internal teams. Support Education & Professional Development Assist with training, mentoring, and supporting clinical research staff, providers, residents, faculty, and students. Maintain up-to-date training in human subjects protection, GCP, and other compliance standards. Manage Financial & Operational Aspects Support the review and management of clinical trial budgets and financial documentation. What You Bring Bachelor's degree required; Master's preferred (Background in nursing, therapy, or other healthcare-related program ideal.) Licensed Registered Nurse preferred 3-5 years of clinical research experience ACRP Clinical Trials Coordinator Certification OR minimum of 5 years of documented experience performing clinical trials Strong knowledge of: Good Clinical Practice (GCP) IRB processes FDA regulatory requirements Excellent verbal and written communication skills Ability to collaborate effectively with physicians, clinical staff, and multidisciplinary teams Strong organizational skills and the ability to manage multiple tasks simultaneously Caring for Our Team We offer a comprehensive benefits package to support our employees' well-being and professional growth. Benefits include health, dental, and vision insurance available starting the 1st of the month following date of hire, along with life insurance, & short and long-term disability coverage. Paid Time Off begins accruing from day one, and we also provide a 401k plan, an education assistance program, and an employee assistance program. Additionally, employees working evening, night, or weekend shifts may be eligible for a shift differential, adding even more value to your role. Happy to Help At Meritus, we believe in a collaborative and caring work environment. Interactions are an opportunity to learn, listen and to be there for one another. Therefore, we provide warm welcomes, hospitality-driven closures, and are always Happy to Help.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Join Our Team at Maryland Oncology Hematology! We're looking for passionate and talented professionals to join our team in providing exceptional cancer care. If you're dedicated to making a difference for patients, physicians, and colleagues, we want to hear from you! With 15+ locations across Maryland and DC, we offer a dynamic and supportive environment where you can grow and thrive. Explore opportunities with us and apply today! The general pay scale for this position at MOH is $58,798 -$77,435. The actual hiring rate is dependent on many factors, including but not limited to prior work experience, education, job/position responsibilities, location, work performance, etc. Job Profile Summary Responsible for recruiting, screening, consenting, and enrolling patient in clinical trials. CRC II also coordinates and oversees the subject's visits in accordance with the protocol requirements. Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers. Acts as resource for the education and training of clinic staff as well as resource for problem solving of complex issues for the implementation of the research process throughout the clinic, process improvements and SOPs. Compiles and reports protocol activity; accrual data, and financial information. Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards. Responsibilities Key Responsibilities * Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials. * Coordinates patient care in compliance with protocol requirements. May disburse investigational drug. Maintains investigational drug accountability. Oversees the preparation of orders by physicians to assure that protocol compliance is maintained. Packages and ships lab specimens to central vendors where applicable. Required to complete Hazmat and/or IATA training. * In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings and participates in data collection of all subjects. * Responsible for preparing study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports. * Maintains regulatory documents in accordance with USOR SOP and applicable regulations. May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite. May collaborate with Research Site Leader in the study selection process. * Participates in required training and education programs. May be responsible for education of clinic staff regarding clinical research. Collaborates with staff in the development of action plans and performance improvement opportunities with staff to improve quality. * May be responsible for compiling and reporting protocol activity, accrual trends, data entry compliance, and research financial information to practice administration and physicians. May be responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel. Qualifications Minimum Job Qualifications (Knowledge, Skills, & Abilities): Education/Training - * Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred. * Minimum three years of experience in a clinical or scientific related discipline required, preferably in oncology. * SoCRA or ACRP certification preferred. Business Experience - * Experience in Microsoft Office * Experience working with physicians preferred * Experience working in clinical research is preferred Specialized Knowledge/Skills - * Must have excellent communication skills * Excellent organizational skills * Strong ability to multi-task * Excellent time management skills * Must have strong interpersonal skills to be able to interact with multiple people on many different levels * Must have a high level of attention to detail * Must be able to work in a fast-paced environment * May be responsible for basic clinical assessments. * The successful candidate will demonstrate extensive experience in patient-facing roles, maintaining a professional and empathetic demeanor while delivering high-quality care. * This position requires a self-motivated individual who can work independently and manage priorities effectively in a fast-paced environment. * This is a full-time, on-site role with a schedule of Monday through Friday. Working Conditions: Environment (Office, warehouse, etc.) - * Traditional office environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements (Lifting, standing, etc.) - * Large percent of time performing computer based work is required The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)

is 100% onsite in Hagerstown, MD Make a meaningful impact in advancing clinical research at Meritus Health. Meritus Health is seeking a highly skilled and motivated Clinical Research Specialist to support the planning, coordination, and daily operations of clinical research trials across our health system. In this vital role, you'll work directly with the Associate Dean of Research, Principal Investigators, sponsors, and regulatory agencies to ensure that every study is conducted with excellence, accuracy, and integrity. What You Will Do As a Clinical Research Specialist, you will: Lead & Support Clinical Research Activities * Assist with the development, implementation, and evaluation of clinical practices for sponsored and Meritus-initiated clinical trials. * Ensure the ethical conduct of research and compliance with all regulatory standards (IRB, FDA, GCP). Manage Regulatory Compliance * Prepare and maintain submissions for federal, state, and local regulatory bodies, including Institutional Review Boards. * Develop and oversee effective systems for required reporting and documentation. Execute Research Protocols * Follow clinical trial protocols in alignment with Good Clinical Practice (GCP). * Support ongoing quality assurance and quality control processes. Drive Research Growth * Identify new research opportunities that align with our system's resources and population. * Support the expansion and development of investigator-initiated and sponsored research programs. Engage Participants & the Community * Assist in participant recruitment and enrollment. * Promote research initiatives to providers, community members, payors, and internal teams. Support Education & Professional Development * Assist with training, mentoring, and supporting clinical research staff, providers, residents, faculty, and students. * Maintain up-to-date training in human subjects protection, GCP, and other compliance standards. Manage Financial & Operational Aspects * Support the review and management of clinical trial budgets and financial documentation. What You Bring * Bachelor's degree required; Master's preferred (Background in nursing, therapy, or other healthcare-related program ideal.) * Licensed Registered Nurse preferred * 3-5 years of clinical research experience * ACRP Clinical Trials Coordinator Certification OR minimum of 5 years of documented experience performing clinical trials * Strong knowledge of: * Good Clinical Practice (GCP) * IRB processes * FDA regulatory requirements * Excellent verbal and written communication skills * Ability to collaborate effectively with physicians, clinical staff, and multidisciplinary teams * Strong organizational skills and the ability to manage multiple tasks simultaneously Caring for Our Team We offer a comprehensive benefits package to support our employees' well-being and professional growth. Benefits include health, dental, and vision insurance available starting the 1st of the month following date of hire, along with life insurance, & short and long-term disability coverage. Paid Time Off begins accruing from day one, and we also provide a 401k plan, an education assistance program, and an employee assistance program. Additionally, employees working evening, night, or weekend shifts may be eligible for a shift differential, adding even more value to your role. Happy to Help At Meritus, we believe in a collaborative and caring work environment. Interactions are an opportunity to learn, listen and to be there for one another. Therefore, we provide warm welcomes, hospitality-driven closures, and are always Happy to Help.

Job DescriptionDescription: We are seeking an on-site Clinical Research Coordinator to join our growing CCAY Clinical Research team! This position is a full-time (Monday-Friday) ON-SITE position in York, PA. About Us For more than 40 years, Cancer Care Associates of York has been an independent, physician-owned practice dedicated to serving the York, PA community. Our mission is to provide compassionate, patient-centered oncology and hematology care while supporting our staff with a collaborative, growth-minded environment. Learn more about us: *********************** What you will be doing... Under the guidance and supervision of the Lead Clinical Research Nurse Coordinator, in collaboration with the Principal Investigator (PI), the Clinical Research Coordinator plays a key role in ensuring the integrity, quality, and compliance of clinical research studies. This position is responsible for supporting and coordinating clinical trials in accordance with Good Clinical Practice (GCP) guidelines as well as applicable federal, state, and local regulations. The Clinical Research Coordinator will actively participate in patient recruitment, informed consent, protocol compliance, data collection, and patient education while maintaining accurate and timely documentation. Essential Functions Qualified individuals must have the ability - with or without reasonable accommodation - to perform the following: Collaborate with PI and research team to develop study timelines, processes, and source documents in adherence to study protocols. Coordinate and participate in study initiation visits and site monitoring activities. Recruit, screen, and enroll patients into clinical trials in alignment with study requirements and enrollment goals. Present study concepts to patients, participate in informed consent discussions, and ensure accurate consent documentation. Collect, process, and verify research data, samples, and/or specimens following strict protocol requirements. Conduct blood draws, EKGs, and obtain patient vitals as needed per the scope of practice. Monitor patients for adverse events, protocol compliance, and response to investigational therapies, thoroughly documenting all findings. Accurately enter, maintain, and review case report forms and research data per FDA guidelines. Maintain investigational product accountability and provide patient education on drug administration procedures. Educate patients, their families, and clinic staff regarding research protocols and investigational agents. Remain audit-ready through consistent, accurate documentation and adherence to regulatory standards. Attend required meetings, ongoing education programs, and maintain certifications such as GCP and IATA. Requirements: Desired Professional Skills and Experience: Previous clinical research experience is preferred. Certified Medical Assistant (CMA), Licensed Practical Nurse (LPN), or Register Nurse (RN) preferred; unlicensed professionals with clinical research experience may be considered. Knowledge of or training in Good Clinical Practice (GCP) guidelines preferred; the candidate will be required to complete GCP training and other training Excellent communication and organizational skills Independence, multitasking, and attention to detail Experience in Microsoft Word and Excel SoCRA or ACRP certification preferred, or willingness to obtain within 2-3 years of hire. What we offer: Competitive Compensation & Generous Paid Time Off 401(K) & Profit Sharing Plan w/ generous company contribution Affordable Medical, Dental, and Vision Plans Life Insurance Plan - company paid Employee Assistance Program Short & Long Term Disability Plans (voluntary) Consistent Day Schedule (M-F) w/ no weekends, evenings or holidays

Full-time (80 hours biweekly) Weekdays, daytime hours and some evenings Coordinates clinical research activities and compliance to study requirements, and patient and staff considerations relative to specific clinical trials and/or studies. Monitors the clinical course and collection of research data for patients in clinical trials. Assists the medical investigators in achieving the objectives of clinical research studies and supports ongoing patient management approaches in the designated disease/treatment area(s). Considers nursing implications in areas of staff and patient educational needs, staff resources, and research objectives. Acts as a resource for clinical and support staff involved in the care of patients enrolled in appropriate studies. Coordinates and performs nursing responsibilities in specialty area(s) for clinical research patients. Minimum Education: Bachelor's Degree Required Master's Degree Preferred Work Experience: 2 years' experience in nursing, medical research, or clinical trials required and Training/experience in the responsible conduct of research, including medical/ research ethics and protection of the safety and welfare of human subjects in research required Licenses: Licensed Registered Nurse Upon Hire Required or Registered Nurse Multi State License Upon Hire Required and Heartsaver CPR/AED Upon Hire Required Certified Clinical Research Coordinator Upon Hire Preferred or Certified Clinical Research Professional Upon Hire Preferred Courses and Training: Appropriate RN specialty certification. Upon Hire Preferred Benefits Offered: Comprehensive health benefits Flexible spending and health savings accounts Retirement savings plan Paid time off (PTO) Short-term disability Education assistance Financial education and support, including DailyPay Wellness and Wellbeing programs Caregiver support via Wellthy Childcare referral service via Wellthy For additional details: Benefits & Incentives | WellSpan Careers (joinwellspan.org) ** Please submit your resume and outline the names of the research trials which you have worked with in the past. Essential Functions: Participates in the review of research protocols and assesses the appropriateness, feasibility and resource requirements for implementation. Serves as the principle liaison for project, developing plans and tools as needed to conduct research. Performs nursing responsibilities for nursing care based on research study requirements. Assists investigators in evaluating the quality of care and compliance to protocol requirements. Follows by ensuring compliance with all guidelines for human subject protection and research. Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding source if needed. Maintains an excellent working knowledge of all protocols. Develops and conducts formal and informal education to inform clinical and other staff of implications of protocol procedures. Distributes protocol and patient information in a timely manner. Oversees patient pretreatment, eligibility and informed consent documentation requirements are met as per the GCP, FDA and IRB guidelines. Registers and accomplishes randomization of patients enrolled in research studies. Documents record of institutional patient registration. Coordinates, observes and/or records data for protocol therapy. Monitors dosage modifications and actively participates in assessing patients for toxicity and response using chart review and physical assessment skills and communication with physicians and nurses. Evaluates and identifies potentially eligible protocol patients, and verifies according to protocol requirements. Provides direct patient education regarding protocol participation, and provides additional information as appropriate. Ensures the integrity of the informed consent process and assists in obtaining informed consent from patients. Works with internal and external registration and scheduling personnel as appropriate to facilitate study entry. Coordinates, observes and/or records data for protocol therapy. Actively participates in assessing patients for toxicity and response using chart review and physical assessment skills and communication with physicians and nurses. Adheres to all protocol requirements to ensure validity of clinical research patient data. Submits complete and accurate forms and materials to external agencies as required in accordance with protocol requirements. Coordinates protocol-related patient activities to ensure protocol compliance and optimal patient scheduling. Designs and compiles forms and educational materials to aid physicians and staff in complying with protocol requirements including tests and follow up visits. Monitors and facilitates necessary documentation in the conduct of clinical research studies. Regularly reviews protocol study forms for accuracy and compliance to protocol standards. Performs consistency checks, edits for errors, and monitors timeliness of data submission. Identifies system inadequacies and augments the system as necessary. Prepares and/or processes adverse event reports on protocol patients and submits these to the principal investigator and appropriate agencies. Alerts investigators and appropriate personnel of communications received regarding adverse events or drug reaction reports or investigational device related issues. Oversees the receipt, secure storage and dispensing of medications provided for protocol patients. Reviews investigational drug logs and inventories to assure that appropriate documentation is maintained and federal guidelines are met. Coordinates all site visit audits. Gathers records and other necessary materials required for audits. Reviews records with all site visit teams and responds to audit reports in a timely manner. Develops and maintains effective and ongoing communication with clinical research participants, the Sponsor and PI. Acts as a liaison between national cooperative groups, institutional investigators, staff and affiliate groups. Triages patient calls, attending to or resolving problems and answering questions. Suggests improved methods for accomplishing research goals. Remains flexible with scheduling to ensure that active research trials and clinical research participants are covered. Travels to additional WellSpan sites as required to execute trials. Attends and participates in research team meetings; educational research and clinically relevant workshops to maintain skill set, knowledge base and continuing educational credits. Common Expectations: Is knowledgeable of and complies with institutional research policies, procedures and guidelines. With the oversight of the Director of Research/Human Subjects Protection Administrator, has knowledge of and complies with governmental regulations regarding responsible conduct of research, research ethics and integrity and protection of the safety and welfare of human subjects (i.e., DHHS, FDA and IRB research regulations, HIPAA privacy and research regulations and others as applicable, such as those governing specimen banks, genetic research, etc.). Instructs less experienced personnel and advises others to insure that research is conducted safely and in compliance with the above. Reports apparent or potential problems to the Director of Research/Human Subject Protection Administrator and the appropriate Service Line Leader. Demonstrates knowledge of the principles of growth and development over the life span of the assigned patient population. Assesses and interprets patient age specific data and provides appropriate, age specific treatment. Provides direct patient care to assigned patient age group(s). Provides outstanding service to all customers; fosters teamwork; and practices fiscal responsibility through improvement and innovation. Attends meetings as required.

This job manages physician preference items (PPI) at Allegheny Health Network in the Neurosurgical and Orthopedic categories. The awarded candidate is responsible for developing specialty specific physician panels to drive product and process decisions throughout the network. Following the contract creation process, the incumbent ensures that compliance levels are maintained for select PPI contracts as well as supports Provider Supply Chain Partner's business development. Additionally, the incumbent is responsible for generating savings opportunities to contribute to supply chain's annual savings goal. **ESSENTIAL RESPONSIBILITIES** + Build relationships with physicians and clinical staff within the service line to manage a broad based group of contract categories. As the liaison between the vendors and the physicians/staff, work with the vendors to ensure that they are providing the proper training and support for the procedures. Follow regular call pattern with physicians to enhance engagement. + Partner with the physician panel members to develop PPI contracts, work through requests for new technologies and support resolution of any product issues across their practice. + Drive compliance and standardization across the service line within partner organizations working with physicians to ensure proper usage of on-contract products. + Support clinical contracting across a broad based group of contract categories to reach savings goals by facilitating clinician involvement in decision making. + Meet with senior leadership throughout partner organizations to discuss conversion and/or implementation plans, financial impact, as well as clinical perspective. + Support business development for Provider Supply Chain Partners by serving as the clinical expert to help drive contract penetration at the affiliate hospitals. + Train and mentor other Clinical Integration Coordinators on the team to help them work through the contracting process and any compliance concerns. + Other duties as assigned. **EDUCATION** **Required** + Bachelors Degree in Business Administration/Management **Substitutions** + Any applicable (Bachelors or Higher) degree may be substituted for a degree in management **Preferred** + None **EXPERIENCE** **Required** + 7 - 10 years in the Healthcare Industry + 3 - 5 years in Sales **Preferred** + 3 - 5 years in Medical Sales + 1 - 3 years in Clinical Services **LICENSES OR CERTIFICATIONS** **Required** + None **Preferred** + None **SKILLS** + Relationship-builder with Unsurpassed Interpersonal Skills + Building and Leading Teams + Communication Skills + Continuous Improvement + Cost Saving Initiatives + Excellent Multi-Tasker + Leading Effective Meetings + Creative Problem Solving + Analytical and Logical Reasoning/Thinking **Languages (other than English)** None **Travel Requirement** 50% - 75% **PHYSICAL, MENTAL DEMANDS and WORKING CONDITIONS** **Position Type** Remote Teaches / trains others regularly Occasionally Travel regularly from the office to various work sites or from site-to-site Frequently Works primarily out-of-the office selling products/services (sales employees) Never Physical work site required Yes Lifting: up to 10 pounds Does Not Apply Lifting: 10 to 25 pounds Does Not Apply Lifting: 25 to 50 pounds Does Not Apply **_Disclaimer:_** _The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job._ **_Compliance Requirement:_** _This position adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies._ As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company's Handbook of Privacy Policies and Practices and Information Security Policy. Furthermore, it is every employee's responsibility to comply with the company's Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements. **Pay Range Minimum:** $67,500.00 **Pay Range Maximum:** $126,000.00 _Base pay is determined by a variety of factors including a candidate's qualifications, experience, and expected contributions, as well as internal peer equity, market, and business considerations. The displayed salary range does not reflect any geographic differential Highmark may apply for certain locations based upon comparative markets._ Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law. We endeavor to make this site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact the email below. For accommodation requests, please contact HR Services Online at ***************************** California Consumer Privacy Act Employees, Contractors, and Applicants Notice Req ID: J270477

USRC's greatest strength in being a leader in the dialysis industry is our ability to recognize and celebrate the differences in our diverse workforce. We strongly believe in recruiting top talent and creating a diverse and inclusive work climate and culture at all levels of our organization. The Clinical Coordinator is responsible for assisting with management and operation of clinic. This position assumes full responsibility for the dialysis clinic in the absence of the Administrator. Growth: Assist with clinical and operational processes to improve patient health and minimize hospitalizations and missed treatments. Assist with planning/coordinating patient scheduling to assure timely acceptance of patients and effective staffing levels. Demonstrate effective use of supplies and staff labor hours. Responsible for updating all logs and ensuring that dialysis run sheets and logs are sent to billing. Perform duties as assigned to meet the patient care or operational needs of the clinic. Outcomes: Coordinate the functions of all departments and develop standards and methods of measuring patient care services, including a chronological record of services provided to patients as required by the ESRD Network Coordinating Council and Medicare. Work with Administrator to maintain chronological, thorough, and appropriate documentation in the patient record of all treatments, activities, and communication with the patient, physician, and other healthcare professionals. Promote quality management program through education and involvement of staff and patients in outcomes as well as overall responsibility to achieve corporate goals for quality. Assist with program's target goals for patient outcomes in accordance with quality patient care and Company goals. Review all incident reports; make recommendations and take action relative to incidents as appropriate; report at monthly QAPI meeting as delegated by Administrator or Management. Operational Readiness: Knowledge of and remain current with federal, state, local laws and regulations, including health care professionals practice act requirements. Work with Administrator to assure clinic is in compliance with all applicable federal, state, and local laws and regulations. Assist Administrator with development, implementation and follow up of Corrective Action Plans required for internal and external surveys. May assume Charge Nurse's responsibilities as needed. May fulfill responsibility of facility Alternate CEO as delegated by Governing Body. Conduct and/or participate in both formal and informal meetings with the governing body, Regional Director, Medical Director and the staff as delegated. Assure that appropriate staff meetings, in-service education meetings, and team patient care planning meetings are held monthly as delegated. Assure that Quality Assessment & Performance Improvement Program is current at all times as delegated. Establish, maintain, and submit all required records and reports concerning staff, patients, and the operational affairs of the center if delegated by Administrator. Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly. Oversee the maintenance of equipment and supplies to meet current laws and regulations. Responds to all emergencies in clinic. Familiar with emergency equipment and all emergency operational procedures. Supervise the maintenance of equipment, building areas occupied by the center and other property belonging to the center. Partnerships: Maintain collaborative working relationship with Medical Director and physicians. Establish and maintain a positive relationship with all Administrators, area hospitals, agencies, vendors and the community. Actively promote GUEST customer service standards; develop effective relationships at all levels of the organization. Respond effectively to inquiries or complaints. Staff Development: Ensure all staff meet required qualifications for position held and perform duties within limitations established by and in accordance with company policy/procedures, health care professionals practice acts, applicable state and federal laws and regulations. Serves as a resource/subject matter expert for patient needs and concerns, staff education and in-service sessions as necessary. Assists with recruitment, training, development, and supervision of all personnel. Assists with maintaining effective personnel management and employee relations, including evaluating the performance of all personnel and counseling employees. Uphold management goals of corporation by leading staff in team concepts and promoting a team effort. Effectively communicate expectations; accept accountability and hold others accountable for performance.

Who We Are: Santé Group Companies prides itself in being a leader in community-based behavioral and mental health services. Our track record of innovation and growth reflects our ability to deliver diverse and highly individualized services. We have a passion for providing empathetic and potentially life-saving care to help individuals heal, recover, and thrive, as well as live their lives in a manner that allows them to fully integrate in the community. The Santé Group aspires to create an organization that places value on collaboration, innovation, creativity, and inclusiveness. To achieve this success, it is essential that all members of our organization feel secure, welcome, and respected. All members of our organization have a responsibility to uphold these values. What We're Looking For: Sante is seeking a Full-Time Clinical Coordinator to join our new Regional Mobile Response (MRT) Team in Westminster, MD. As the Regional MRT Clinical Coordinator, you will make an unprecedented impact on your community by overseeing the daily operation of the Regional Mobile Response Team. The Regional MRT Clinical Coordinator will oversee the operation of the Regional MRT Team and work closely with the 988 Call Center program within the Greater Baltimore Regional Integrated Crisis System (GBRICS) Partnership. You will provide the administrative and clinical supervision to all staff associated with the project. By joining Sante and supporting its mission, you will make more than a living, you will make a difference. This is an IN-PERSON role. No option for remote work. This is a supervisory role. What You'll Do: * Provide training, consultation, supervision, and clinical oversight for Regional MRT Team and schedule and conduct staff meetings. * Available 24/7 as an on-call supervisor. * Partner with Human Resources to interview, hire, and onboard new staff. * Work schedules to ensure shift coverage and compliance with contract requirements. * Review and consult with staff on open cases and ensures accurate, thorough, and timely documentation. * Collaborate with Regional MRT Director to develop policies, procedures, and to ensure effective supervision for all staff. * Assist with record releases, auditing, and responsible for statistical analysis and reporting for the Call Center Program. * Participate in GBRICS collaborative meetings and serve as a liaison to GBRICS partners. * Participate in Community Boards and Committees to develop and facilitate trainings for the community as requested. What We Require: * Master's Degree in Social Work, Counseling with two (2) years of related experience. * Must possess and maintain current licensure in the State of Maryland (LCSW-C or LCPC) * Board Approved Supervisor in the State of Maryland. * Valid driver's license and proof of current automobile insurance. * Ability to work a shift 11am - 7pm Monday - Friday What You'll Get: * Salary for this role is $90,000.00 annually. Salary awarded is dependent upon licensure and experience. * Financial assistance for licensure fees, (if applicable) * No cost supervision for clinical licensure (if applicable) * Opportunities for career growth, training and development, flexible work schedules and shifts * Company-wide wellness program. * Paid parental leave * The rare opportunity to make a difference in the very community that you call home. We are leading providers in Behavioral and Mental Health! * Smart, passionate, and engaged coworkers. Disclaimers: The Santé Group aspires to create an organization that places value on collaboration, innovation, creativity, and inclusiveness. To achieve this success, it is essential that all members of our organization feel secure, welcome, and respected. All members of our organization have a responsibility to uphold these values. The Santé Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, or disability status. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. The Santé Group participates in E-Verify. **************************************************************** #LI-SC2

UPMC is hiring a Clinical Transplant Coordinator! This is a full time, day shift position with an on call and weekend rotation required, and those with ED and Critical Care experience are encouraged to apply! Travel to other sites within PA throughout the month is required. Purpose: This Clinical Transplant/VAD Coordinator I has the authority, responsibility, and accountability for the delivery of nursing care through the use of the nursing process. The Clinical Transplant/VAD Coordinator I, in collaboration with Clinical Transplant/VAD Coordinators IIs, Supervisor, Clinical Transplant/VAD Coordinators, the transplant/VAD team and other health care professionals, applies competent clinical knowledge and skills to achieve quality care outcomes. The Clinical Transplant/VAD Coordinator I must demonstrate the entry-level knowledge and skills necessary to provide care that is relevant to patients under their care, as well as apply principles of growth and development over the life span. The Clinical Transplant/VAD Coordinator I also must possess the ability to assess and interpret patient data needed to identify each patient's requirements relative to his or her age specific needs. Responsibilities: * TRANSPLANT/VAD REFERRAL AND EVALUATION1. Identifies appropriate transplant/VAD candidates upon referral and interacts with appropriate hospital staff.2. Identifies requirements for candidate evaluation.3. Coordinates the evaluation process for potential transplant/VAD candidates with the multidisciplinary team.4. Functions as candidate advocate by applying knowledge of growth, development, educational and cultural background during candidate and family interaction.5. Provides data to regulatory agencies.6. Demonstrates knowledge of compliance with United Network for Organ Sharing (UNOS) policies and listing requirements. * POST-TRANSPLANT/VAD OUT-PATIENT PERIOD21. Identifies and responds to recipient and family needs in post-transplant/VAD phase.22. Reinforces educational and follow-up requirements.23. Collects and reviews data pertinent to recipient's health and organ function.24. Provides and maintains comprehensive documentation of recipient's progress.25. Implements changes in drug therapy as ordered by physician.26. Arranges for consultations, diagnostic procedures, and hospitalization when indicated.27. Maintains communication with referring physician and other health care providers.28. Assesses recipient's compliance with medications and medical regime; collaborates with transplant/VAD team to attain and maintain compliance. * POST-TRANSPLANT/VAD IN-PATIENT PERIOD18. Monitors patient progress post-transplant.19. Educates recipient and family regarding care and responsibilities after transplantation.20. Collaborates with transplant/VAD team to establish and implement patient plan of care. * PROFESSIONAL GROWTH AND DEVELOPMENT29. Obtains ABTC Certification.30. Attends practice-related conferences.31. Participates in educational and outreach activities. 32. Constructively receives feedback and direction.33. Identifies and communicates learning needs to manager. 34. Takes action to improve knowledge, skills and performance based on feedback or on self-identified developmental needs.35. Participates in self-review as requested by manager.36. Responsible for adhering to On-Call schedule. * PERI-OPERATIVE PERIOD13. Participates in transplant/VAD process according to UPMC protocol.14. Reviews potential recipient's current medical status to determine eligibility for transplant.15. Facilitates admission or transfer to UPMC.16. Communicates with organ procurement agency/ORC and collects the appropriate data necessary for decision making re organ acceptance/rejection for transplant as applicable.17. Exhibits ability to remove transplant recipient from the list per UNOS regulations as applicable. * PRE-TRANSPLANT/VAD PERIOD7. Develops and institutes a teaching plan addressing transplant/VAD candidates learning needs.8. Maintains communication with patient and referring physician.9. Recognizes potential problems and/or significant changes during the waiting period and coordinates required care.10. Acts as a resource person for internal and external health care providers.11. Provides and maintains comprehensive documentation of candidate process.12. Exhibits ability to maintain and update candidate listing status per UNOS regulations as applicable. Qualifications: 2 years recent clinical nursing experience. Demonstrated competence in professional nursing practice. Diploma or Associates Degree in Nursing. BSN preferred. Must obtain a Solid/Strong/Good or higher on annual performance review to be promoted to Clinical Transplant/VAD Coordinator II. Licensure, Certifications, and Clearances: Current Pennsylvania licensure as a Registered Professional Nurse. It is preferred that within 2 years employee will obtain and maintain certification from the American Board for Transplant Certification (ABTC) as a Certified Clinical Transplant Coordinator (CCTC), CHFN (Certified Heart Failure Nurse), or other UPMC approved certification associated with the service line upon eligibility in order to be promoted to Clinical Transplant Coordinator II. * Advanced Cardiac Life Support (ACLS) * Registered Nurse (RN) * Act 34 * Current licensure either in the state where the facility is located or, if the facility is in a state covered by the multistate Nursing Licensure Compact (NLC) agreement, a multistate license issued by a participating NLC state. Hires and current employees working on an out-of-state NLC license who later change their residency to the state where the facility is also located will have 60 days upon changing their residency to apply for licensure within that state. UPMC is an Equal Opportunity Employer/Disability/Veteran

**UPMC is hiring a Clinical Transplant Coordinator! This is a full time, day shift position with an on call and weekend rotation required, and those with ED and Critical Care experience are encouraged to apply! Travel to other sites within PA throughout the month is required.** **Purpose:** This Clinical Transplant/VAD Coordinator I has the authority, responsibility, and accountability for the delivery of nursing care through the use of the nursing process. The Clinical Transplant/VAD Coordinator I, in collaboration with Clinical Transplant/VAD Coordinators IIs, Supervisor, Clinical Transplant/VAD Coordinators, the transplant/VAD team and other health care professionals, applies competent clinical knowledge and skills to achieve quality care outcomes. The Clinical Transplant/VAD Coordinator I must demonstrate the entry-level knowledge and skills necessary to provide care that is relevant to patients under their care, as well as apply principles of growth and development over the life span. The Clinical Transplant/VAD Coordinator I also must possess the ability to assess and interpret patient data needed to identify each patient's requirements relative to his or her age specific needs. **Responsibilities:** + TRANSPLANT/VAD REFERRAL AND EVALUATION1. Identifies appropriate transplant/VAD candidates upon referral and interacts with appropriate hospital staff.2. Identifies requirements for candidate evaluation.3. Coordinates the evaluation process for potential transplant/VAD candidates with the multidisciplinary team.4. Functions as candidate advocate by applying knowledge of growth, development, educational and cultural background during candidate and family interaction.5. Provides data to regulatory agencies.6. Demonstrates knowledge of compliance with United Network for Organ Sharing (UNOS) policies and listing requirements. + POST-TRANSPLANT/VAD OUT-PATIENT PERIOD21. Identifies and responds to recipient and family needs in post-transplant/VAD phase.22. Reinforces educational and follow-up requirements.23. Collects and reviews data pertinent to recipient's health and organ function.24. Provides and maintains comprehensive documentation of recipient's progress.25. Implements changes in drug therapy as ordered by physician.26. Arranges for consultations, diagnostic procedures, and hospitalization when indicated.27. Maintains communication with referring physician and other health care providers.28. Assesses recipient's compliance with medications and medical regime; collaborates with transplant/VAD team to attain and maintain compliance. + POST-TRANSPLANT/VAD IN-PATIENT PERIOD18. Monitors patient progress post-transplant.19. Educates recipient and family regarding care and responsibilities after transplantation.20. Collaborates with transplant/VAD team to establish and implement patient plan of care. + PROFESSIONAL GROWTH AND DEVELOPMENT29. Obtains ABTC Certification.30. Attends practice-related conferences.31. Participates in educational and outreach activities. 32. Constructively receives feedback and direction.33. Identifies and communicates learning needs to manager. 34. Takes action to improve knowledge, skills and performance based on feedback or on self-identified developmental needs.35. Participates in self-review as requested by manager.36. Responsible for adhering to On-Call schedule. + PERI-OPERATIVE PERIOD13. Participates in transplant/VAD process according to UPMC protocol.14. Reviews potential recipient's current medical status to determine eligibility for transplant.15. Facilitates admission or transfer to UPMC.16. Communicates with organ procurement agency/ORC and collects the appropriate data necessary for decision making re organ acceptance/rejection for transplant as applicable.17. Exhibits ability to remove transplant recipient from the list per UNOS regulations as applicable. + PRE-TRANSPLANT/VAD PERIOD7. Develops and institutes a teaching plan addressing transplant/VAD candidates learning needs.8. Maintains communication with patient and referring physician.9. Recognizes potential problems and/or significant changes during the waiting period and coordinates required care.10. Acts as a resource person for internal and external health care providers.11. Provides and maintains comprehensive documentation of candidate process.12. Exhibits ability to maintain and update candidate listing status per UNOS regulations as applicable. 2 years recent clinical nursing experience. Demonstrated competence in professional nursing practice. Diploma or Associates Degree in Nursing. BSN preferred. Must obtain a Solid/Strong/Good or higher on annual performance review to be promoted to Clinical Transplant/VAD Coordinator II. **Licensure, Certifications, and Clearances:** Current Pennsylvania licensure as a Registered Professional Nurse. It is preferred that within 2 years employee will obtain and maintain certification from the American Board for Transplant Certification (ABTC) as a Certified Clinical Transplant Coordinator (CCTC), CHFN (Certified Heart Failure Nurse), or other UPMC approved certification associated with the service line upon eligibility in order to be promoted to Clinical Transplant Coordinator II. + Advanced Cardiac Life Support (ACLS) + Registered Nurse (RN) + Act 34 *Current licensure either in the state where the facility is located or, if the facility is in a state covered by the multistate Nursing Licensure Compact (NLC) agreement, a multistate license issued by a participating NLC state. Hires and current employees working on an out-of-state NLC license who later change their residency to the state where the facility is also located will have 60 days upon changing their residency to apply for licensure within that state. **UPMC is an Equal Opportunity Employer/Disability/Veteran**

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Senior CRA / CRA II 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-ZH1 \#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

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Full-time Description We are seeking an on-site Clinical Research Coordinator to join our growing CCAY Clinical Research team! This position is a full-time (Monday-Friday) ON-SITE position in York, PA. About Us For more than 40 years, Cancer Care Associates of York has been an independent, physician-owned practice dedicated to serving the York, PA community. Our mission is to provide compassionate, patient-centered oncology and hematology care while supporting our staff with a collaborative, growth-minded environment. Learn more about us: *********************** What you will be doing... Under the guidance and supervision of the Lead Clinical Research Nurse Coordinator, in collaboration with the Principal Investigator (PI), the Clinical Research Coordinator plays a key role in ensuring the integrity, quality, and compliance of clinical research studies. This position is responsible for supporting and coordinating clinical trials in accordance with Good Clinical Practice (GCP) guidelines as well as applicable federal, state, and local regulations. The Clinical Research Coordinator will actively participate in patient recruitment, informed consent, protocol compliance, data collection, and patient education while maintaining accurate and timely documentation. Essential Functions Qualified individuals must have the ability - with or without reasonable accommodation - to perform the following: Collaborate with PI and research team to develop study timelines, processes, and source documents in adherence to study protocols. Coordinate and participate in study initiation visits and site monitoring activities. Recruit, screen, and enroll patients into clinical trials in alignment with study requirements and enrollment goals. Present study concepts to patients, participate in informed consent discussions, and ensure accurate consent documentation. Collect, process, and verify research data, samples, and/or specimens following strict protocol requirements. Conduct blood draws, EKGs, and obtain patient vitals as needed per the scope of practice. Monitor patients for adverse events, protocol compliance, and response to investigational therapies, thoroughly documenting all findings. Accurately enter, maintain, and review case report forms and research data per FDA guidelines. Maintain investigational product accountability and provide patient education on drug administration procedures. Educate patients, their families, and clinic staff regarding research protocols and investigational agents. Remain audit-ready through consistent, accurate documentation and adherence to regulatory standards. Attend required meetings, ongoing education programs, and maintain certifications such as GCP and IATA. Requirements Desired Professional Skills and Experience: Previous clinical research experience is preferred. Certified Medical Assistant (CMA), Licensed Practical Nurse (LPN), or Register Nurse (RN) preferred; unlicensed professionals with clinical research experience may be considered. Knowledge of or training in Good Clinical Practice (GCP) guidelines preferred; the candidate will be required to complete GCP training and other training Excellent communication and organizational skills Independence, multitasking, and attention to detail Experience in Microsoft Word and Excel SoCRA or ACRP certification preferred, or willingness to obtain within 2-3 years of hire. What we offer: Competitive Compensation & Generous Paid Time Off 401(K) & Profit Sharing Plan w/ generous company contribution Affordable Medical, Dental, and Vision Plans Life Insurance Plan - company paid Employee Assistance Program Short & Long Term Disability Plans (voluntary) Consistent Day Schedule (M-F) w/ no weekends, evenings or holidays

Clinical Trial Manager II- Remote- United States 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 **Clinical Trial Manager II** to join our diverse and dynamic team. As a Clinical Trial Manager II 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. This role with be supporting our Early Phase team. **What you will be doing** + Collaborate with cross-functional teams to design and implement effective clinical trial enrollment Collaborating with cross-functional teams to develop and implement comprehensive clinical trial protocols. + Overseeing and managing the day-to-day operations of clinical trials, ensuring compliance with regulatory standards. + Analyzing and interpreting clinical trial data, identifying trends, and providing insights to optimize study outcomes. + Proactively addressing challenges and implementing effective solutions to ensure the successful execution of clinical trials. + Communicating effectively with internal and external stakeholders to foster strong partnerships and facilitate smooth trial processes. **Your profile** + Bachelor's degree in a relevant field, with a **minimum of** **1.5 years** of experience as a Clinical Trial Manager within in a CRO environment. + Experience supporting early phase clinical trials is HIGHLY preferred + Proven expertise in designing and executing clinical trials, with a strong understanding of regulatory requirements. + Site monitoring experience preferred + Exceptional analytical and problem-solving skills, with the ability to interpret complex medical data. + Effective communication and interpersonal skills, with the ability to collaborate across diverse teams. + Detail-oriented and organized, with a track record of successfully managing multiple tasks and priorities simultaneously. \#LI-Remote \#LI-MN1 **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