Clinical coordinator jobs in Franklin, NJ - 477 jobs

Clinical Trial Associate - Consultant (No third parties or C2C) *This role is with a global pharmaceutical company located in NJ. Mandatory 3 days per week onsite* Key Responsibilities: Coordinate meetings, including scheduling, agenda preparation, and minute-taking. Gather data for feasibility assessments and site selection, and maintain site usability records. Review study documents (e.g., informed consent forms, case report forms) in compliance with SOPs. Assemble and update study manuals and maintain version control of study materials. Monitor site activation, enrollment, and study progress, and escalate any issues or deviations. Maintain investigator and site status updates, and support clinical trial registry postings. Perform regular reconciliations of the Trial Master File (TMF). Ensure timely receipt of required reports (e.g., 1572 changes, financial disclosures). Manage team SharePoint or shared drive sites and maintain site contact information. Assist in managing third-party vendors and tracking study close-out activities. Participate in SOP revisions and propose process improvements. Qualifications: Strong attention to detail and ability to manage study activities effectively. Good communication and interpersonal skills. Problem-solving abilities and proactive approach to tasks. Familiarity with trial management systems and MS Office applications. Basic understanding of clinical drug development and ICH/GCP guidelines. Experience: Bachelor's degree with 5+ of relevant experience

About the Company: Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. POSITION SUMMARY Reporting to the Vice President, Clinical Development. The Clinical Trial Associate, Late Development (IIT, Registry) [GI] will play a key role in supporting the planning, execution, and management of late phase clinical trials by providing clinical, scientific, and administrative support. The role collaborates closely with the Clinical Trial Manager (CTM) and relevant teams in HQ to ensure effective trial conduct in accordance with applicable regulations and company policies. KEY ROLES AND RESPONSIBILITIES Support the preparation and maintenance of clinical trial documentation, including study protocols and Clinical Study Reports (CSRs), in compliance with regulatory and internal requirements. Provide operational support to Clinical Operations in collaboration with the CTM. Contribute evidence-based medical and scientific input to late-phase clinical trials under appropriate supervision. Support site selection activities and participate in site-boosting visits within the United States, as required. Prepare and maintain scientific literature summaries and assist in the development of clinical data presentations. Maintain regular communication with cross-functional stakeholders, including teams at Headquarters (South Korea). Support medical-related activities within the Clinical Development and Medical Affairs department in accordance with applicable laws, regulations, and company policies. This is a hybrid role. Can work on-site at our Jersey City, NJ office. WORK EXPERIENCE Minimum of three (3) years of experience in clinical research, clinical trials, or a related field Willingness and ability to travel up to approximately 25%, with or without reasonable accommodation QUALIFICATIONS Ability to learn and adhere to company policies, procedures, and compliance requirements Demonstrated ability to work proactively in a regulated environment Ability to communicate effectively in English, both verbally and in writing Demonstrated effective written and verbal communication skills Ability to collaborate effectively across multiple functional teams Ability to communicate in Korean at an intermediate level is preferred but not required EDUCATION Bachelor's degree in Life Sciences, Medicine, Pharmacy, or a related discipline, or an equivalent combination of education and experience. CORE COMPETENCIES Knowledge - medical terminology and regulatory requirements. Communication - clear, concise, and ability to motivate; ability to articulate medical information of the Company's products. Collaboration - ability to communicate across functions and at all levels in the organization. Compliance - understands industry regulations to maintain compliance. Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-MDRD

The Patient Access Coordinator- Intake Specialist at Performance Ortho will support the Patient Access Team by managing the intake process, ensuring seamless scheduling, and delivering an extraordinary patient experience. Reporting directly to the Patient Access Manager, this role is critical to maintaining operational efficiency and meeting the needs of new and returning patients. Schedule: Onsite in our Bridgewater, NJ location Monday: 10:00am-3:00pm; 5:00-8:00pm (remote) Tuesday: 9:00am-6:00pm (1hr lunch) Wednesday: 10:00am-3:00pm; 5:00-8:00pm (remote) Thursday: 9:00am-6:00pm (1hr lunch) Friday: 9:00am-6:00pm (1hr lunch) Key Responsibilities Patient Intake: Address new patient inquiries and incoming calls professionally, providing timely and thorough assistance. Scheduling: Accurately manage appointments for new and returning patients, ensuring schedules align with patient and provider availability. Medical Record Coordination: Secure diagnostic tests, referrals, and chart notes from external facilities and ensure they are available for provider review. Documentation: Maintain complete and accurate records of patient interactions, including updates to charts and treatment plans. Paperwork Management: Provide patients with necessary forms, ensuring submission before their scheduled appointments. HIPAA Compliance: Uphold confidentiality and compliance standards in all patient interactions and data handling. Support Team Operations: Assist in maintaining productivity by contributing to team coverage, addressing time-sensitive tasks, and performing other duties as assigned by management. Qualifications Essential 3-5 years of experience in customer service, hospitality, or healthcare administration. Strong interpersonal and phone communication skills. Excellent problem-solving abilities and a commitment to providing exceptional patient care. Detail-oriented with the ability to manage multiple priorities in a fast-paced environment. Proficiency in administrative and office management tasks. Desired Experience in a medical or clinical office setting. Bachelor's degree in healthcare administration, business, or a related field. Familiarity with medical records management and scheduling software. What We Offer Competitive compensation and benefits package. Opportunities for professional development and growth. A supportive, team-driven environment that fosters innovation and excellence. Why This Role Matters This position ensures the Patient Access Team operates efficiently, meeting both patient care demands and operational goals. With a focus on professionalism, attention to detail, and patient satisfaction, the Patient Access Coordinator / Intake Specialist will contribute to the seamless delivery of high-quality care.

Are you ready to be a pivotal force in groundbreaking cancer research? RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management. We're seeking someone with a knack for multitasking, a positive outlook, and an undeniable passion for making a difference. If you're eager to join a team that's leading the charge in cutting-edge cancer care and places the patient at the forefront, we want to hear from you! Employment Type: Full Time Location: Freehold, NJ Compensation: $27.09 - $36.54 per hour Compensation packages based on your unique skills, experience, and qualifications As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities. We believe these benefits underscore our commitment to the well-being and professional growth of our employees. ESSENTIAL DUTIES AND RESPONSIBILITIES: Demonstrate understanding of the protocol elements and requirements. Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality. Screening, recruit, enroll prospective patients using EMR, EDC, CTMS Create and maintain enrollment logs for each trial from beginning to end Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial. Collaborates with the cross functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistances, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial. Oversee study kits, study drug accountability records, study kits/IMP drug destruction and maintenance. Enter all the data to EDC, and EMR within 24 hours of data collection. Communicate and resolve all the data queries within 5-days Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator. Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug ice storage for the specimens, temperature logs and other required essential documents Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times. Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements. Interacts with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues. Supports internal and external audits Ability to take initiative to resolve protocol-related concerns and discrepancies. Generate solutions to barriers and opportunities for improvements. Centrifuge, process, prepare, ship, and store biological materials by the sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions. Conduct clinical trial weekly and monthly meetings within the division. Require attending SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings. Track and submit clinical trial patient reimbursement. Other duties as assigned. Requirements Minimum Job Qualifications: Minimum 1 year of experience with oncology interventional clinical trials. ACRP (CCRC, CCRA) or SoCRA (CCRP) Certified Clinical Research Professional with one year of oncology trial experience. High School diploma with four years of oncology clinical trial experience. Computer literate with good interpersonal, writing, and verbal communication skills. Previous regulatory affairs experience is a plus. Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm in all RCCA network. Prior experience working with centrifuge and handling biofluid specimens is preferred. Ability to multi-task and prioritize in a fast-paced work environment, time management skills, and ability to work well under pressure. Working Conditions: Traditional office environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements (Lifting, standing, etc.) Large percent of time performing computer based work is required The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. Salary Description $27.09 - $36.54

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. The CRA Trainer will play a critical role in developing and delivering global training programs for Clinical Research Associates (CRAs) both Internal and functional service providers (FSPs) to ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs. This position requires a highly organized, proactive individual with deep clinical research experience and a passion for mentoring and education. The CRA Trainer will collaborate with Clinical Operations leadership to standardize best practices and enhance CRA performance across all phases of clinical trials. Responsibilities Design, develop, and implement comprehensive CRA training programs (onboarding and ongoing education). Create training materials, including manuals, SOP guides, and learning modules aligned with regulatory and company standards. Conduct live and virtual training sessions on monitoring practices, site management, and protocol compliance. Mentor CRAs on effective site relationship management, patient recruitment strategies, and data quality oversight. Provide guidance on clinical trial systems (CTMS, EDC, eTMF, IRT, ePRO, etc.) and investigational product accountability. Assess CRA competency through evaluations, feedback sessions, performance metrics, co-monitoring and monitoring report review as needed. Collaborate with the Clinical Project Managers within Clinical Operations to identify training gaps and develop targeted solutions. Stay current with regulatory updates and industry best practices to ensure training content remains relevant. Support development of study-specific training for CRAs and site personnel. Maintain documentation of all training activities for audit readiness. Qualifications Bachelor's degree in health sciences or related field. Experience as a line manager of CRAs and a minimum of 10 years of experience as a CRA, preferred strong oncology trial expertise. Proven ability to conduct and oversee monitoring visits (site evaluation, initiation, interim, close-out) as well as identify gaps with mitigation strategies to address. Excellent verbal and written communication skills; strong presentation and facilitation abilities. In-depth knowledge of ICH-GCP guidelines and clinical trial processes. Critical thinking for troubleshooting monitoring challenges Proficiency in Microsoft Office Suite and clinical trial systems (CTMS, EDC, eTMF, IRT and ePRO). Strong organizational and time management skills; ability to manage multiple priorities. Experience in developing training materials and delivering educational programs preferred. Ability to travel as needed (up to 25%). Compensation and Benefits: The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. The CRA Trainer will play a critical role in developing and delivering global training programs for Clinical Research Associates (CRAs) both Internal and functional service providers (FSPs) to ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs. This position requires a highly organized, proactive individual with deep clinical research experience and a passion for mentoring and education. The CRA Trainer will collaborate with Clinical Operations leadership to standardize best practices and enhance CRA performance across all phases of clinical trials. Responsibilities * Design, develop, and implement comprehensive CRA training programs (onboarding and ongoing education). * Create training materials, including manuals, SOP guides, and learning modules aligned with regulatory and company standards. * Conduct live and virtual training sessions on monitoring practices, site management, and protocol compliance. * Mentor CRAs on effective site relationship management, patient recruitment strategies, and data quality oversight. * Provide guidance on clinical trial systems (CTMS, EDC, eTMF, IRT, ePRO, etc.) and investigational product accountability. * Assess CRA competency through evaluations, feedback sessions, performance metrics, co-monitoring and monitoring report review as needed. * Collaborate with the Clinical Project Managers within Clinical Operations to identify training gaps and develop targeted solutions. * Stay current with regulatory updates and industry best practices to ensure training content remains relevant. * Support development of study-specific training for CRAs and site personnel. * Maintain documentation of all training activities for audit readiness. Qualifications * Bachelor's degree in health sciences or related field. * Experience as a line manager of CRAs and a minimum of 10 years of experience as a CRA, preferred strong oncology trial expertise. * Proven ability to conduct and oversee monitoring visits (site evaluation, initiation, interim, close-out) as well as identify gaps with mitigation strategies to address. * Excellent verbal and written communication skills; strong presentation and facilitation abilities. * In-depth knowledge of ICH-GCP guidelines and clinical trial processes. * Critical thinking for troubleshooting monitoring challenges * Proficiency in Microsoft Office Suite and clinical trial systems (CTMS, EDC, eTMF, IRT and ePRO). * Strong organizational and time management skills; ability to manage multiple priorities. * Experience in developing training materials and delivering educational programs preferred. * Ability to travel as needed (up to 25%). Compensation and Benefits: The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description The Clinical Program Manager will work cross functionally to develop, track and maintain timelines, resource needs and Key Performance Indicators/Key Quality Indicators across clinical development, coordinate clinical program reviews, prepare tracking summary reports/dashboards for leadership and support the team in ensuring adherence to clinical program plan. Job Responsibilities: Enter and maintain resources estimates into PCH product portfolio/resource system Support the development of a standard clinical development timelines, internal KPIs/KQI and collaborate with Clinical development teams to align on these KPI/KQI Maintain and ensure accuracy and alignment of the different reporting tools pertaining to clinical development activities within the organization (timelines, resources, KPIs/KQIs) and develop a best practice process document to improve efficiency and decrease manual intervention. Provides monthly tracking project/KPI/resource reports Coordinate project reviews (sets agenda, prepares content, develop minutes, action plans and ensures follow up) Drive standardization of reporting for clinical development across the various medical franchise Manages PO for contractors Support teams in managing broad process improvement/innovation initiatives within clinical development Qualifications Requirements: Bachelor s Degree. A minimum of 4 years of experience in clinical development or related pharmaceuticals fields is preferred. Project Management Certification preferred, or minimally 3-5 years project experience including budget management experience. Strong planning, tracking, and follow-up skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management. Candidate must have strong knowledge and experience with MS project, planisware, or similar project management systems and excel. Candidate must possess strong communication skills, both oral and written, and the ability to collaborate and align with diverse, cross-functional teams. The candidate needs to have clinical experience, know how to create process maps and master excel. Project Management expertise and PM certification or direct PM training, most candidates to date are over-priced. please submit additional candidates -> Mid-Level Position 6 month position with possibility to be extended to 1 year, Strong planning, tracking, and follow-up skills - Proficient in Excel (including ability to understand programming) Please note: The manager is not looking for a study manager or a CRA/CTA. The candidate will not be working on the operational aspect of our clinical studies but will help project manage our clinical portfolio (across clinical programs/studies from pre-IND to NDA submission) Additional Information Neha Sharma Lead Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter

Site 4 days per week at our Princeton NJ or Miami FL Summit Summit Therapeutics Inc is a biopharmaceutical oncology company with a mission focused on improving quality of life increasing potential duration of life and resolving serious unmet medical needs At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology Summit has multiple global Phase 3 clinical studies including Non small Cell Lung Cancer NSCLC HARMONi Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who were previously treated with a 3rd generation EGFR TKIHARMONi 3 Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLCHARMONi 7 Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLCColorectal Cancer CRC HARMONi GI3 Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration NMPA Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland Overview of Role TheClinical Trial Associate CTAis responsible forsupporting the daily workflow of clinical operations activities They willprovide administrative support to study teams throughout the study Key administrative activities include but are not limited to managing meeting invitations creating agendas and meeting minutes study document filing maintaining study trackers and oversight of the eTMFand vendors Role and Responsibilities Provides administrative support to the clinical operations study team including managing meetinglogistics creating agendas and drafting meeting minutes Executes tasks as assigned by the Clinical Operations Manager including study budget forecasting and tracking Ensuresaccurateandtimelydocumentation including eTMF management studycontractsand financial records in compliance with ICH GCP company policies and regulatory requirements Coordinates clinical operations activities across cross functional teams including contract management vendor oversight site start up and activation protocol deviation Creates andmaintainsstudy related materials such as country and site binders and tracks trial milestones Ensure the eTMF is beingmaintainedup to dateand all essential documents are appropriately filed in the eTMF Collaborates with CROs to ensureaccuratedata collection and entry into the CTMS and EDC Attend and contribute to team meetings taking detailed meeting minutes Supports clinical study management as delegated by Clinical Operations managers including liaison with external vendors Activelyparticipatesin process improvement initiatives to enhance clinical operations efficiency All other duties as assigned Experience Education and Specialized Knowledge and Skills Bachelors degree in biological sciences health sciences or medical field or equivalent combination of education and experience 2 Years of experience in clinical study environment within CRO or Pharmaceutical company Strong understanding of the phases of clinical drug development and clinical operation processes from start up to close out Knowledge of applicable FDA Code of Federal Regulations Good Clinical Practices and ICH guidelines Ability to organize prioritize tasksidentifyand resolve issues efficiently Manage multiple tasks effectively and follow through on assigned tasks Ability to receive general instructions on new assignments and perform routine work independently Collaborate and work effectively within a team and within a multi disciplinary environment Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form Attention to detailaccuracyand confidentiality Critical thinking problem solving ability to work independently Advanced knowledge of software application ex Word Excel PowerPoint Adobe Reader and database software eTMF EDC to support operation of clinical trial databases and electronic filing methods Work in a fast paceddemandingand collaborative environment Demonstrate high ethical standards for honestytruthfulnessand integrity The pay range for this role is 97000 114000 annually Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location This may be different in other locations due to differences in the cost of labor The total compensation package for this position may also include bonus stock benefits andor other applicable variable compensation Summit does not accept referrals from employment businesses andor employment agencies in respect of the vacancies posted on this site All employment businessesagencies are required to contact Summits Talent Acquisition team atrecruitingsmmttxcomto obtain prior written authorization before referring any candidates to Summit

Are you interested in new technology such as Virtual Reality? Have you ever worked in a clinical setting and/or have a desire to help people? Does a major contribution to the advancement of medicine appeal to you? Our mission is to change medicine. We are growing rapidly and are now hiring for an exciting position called XR Clinical Specialist. The individuals we hire for the XR Clinical Specialist role become experts in use of our advanced visualization platform, Precision XR™. They are primarily responsible for technical, educational, and sales support, with both existing and potential customers, to ensure superior outcomes. In addition, the XR Clinical Specialist will build and maintain solid customer relationships, at all levels within their account, and promote the expanded utilization of Company systems. Job Description: Build Virtual Reconstructions of Human anatomy and Pathology with Precision XR™ Assist surgeons with Preoperative Surgical Planning and Intraoperative Surgical Navigation Coordinate, schedule, and conduct XR events Represents Company Procedures during surgeries and patient engagement to provide technical assistance. Provides hands on and remote clinical support to customers. Fulfills Software and Service Contract obligations Basic XR video creation and editing. Educates and trains clinicians and hospital personnel. Assist clinicians in the utilization of Precision XR™ during patient consultations. Provide Precision XR™ expertise during multidisciplinary education sessions (i.e.: Tumor Board) Provides a clinical resource for surgeons, clinicians, and hospital staff. Assists commercial leadership in educating/training new sales representatives and Clinical Specialists. Represents company standards during surgical evaluations and demonstrations. Introduces more complex products and applications to physicians and hospital staff. Works as a team member with the Commercial Sales Team to prioritize customer technical support and service expectation goals. Provides potential leads for new products and customers to the Commercial Team Requirements/Qualifications: Degree, credentials, or experience in a relevant area Excellent interpersonal and verbal communication skills Mechanical/technical ability and manual dexterity Knowledge of medical terminology, specifically related to neurosurgery. Knowledge of 3D stereotactic equipment is preferred. An ability to travel 20-60%, dependent upon account distribution. A medical device background is preferred. Willingness to work a flexible schedule ARRT Certification a plus Open to relocation

Responsibilities: - Build Virtual Reconstructions of Human anatomy and Pathology with Precision VR - Assist surgeons with Preoperative Surgical Planning and Surgical Navigation - Coordinate, schedule, and conduct VR events - Represent Company Procedures during surgeries - Provide hands-on and remote clinical support to customers - Basic VR video creation and editing Educate and train clinicians and hospital personnel We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements Experience: - Bachelor Degree in BioMed/ Biology/ related field - Knowledge of medical terminology, specifically related to neurosurgery - Excellent interpersonal and verbal communication skills - An ability to travel, dependent upon account distribution (quarterly basis) Anatomical medical image knowledge

Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing better access to better solutions - and a better life for those living with diabetes - with the world's first bionic pancreas called the iLet. The iLet Bionic Pancreas is the first and only insulin delivery system that does not require carb counting*, bolusing, correction factors, or pre-set basal rates. The only number needed to get started with the iLet Bionic Pancreas is a user's weight - the iLet does the rest. The iLet lets users “Go Bionic” with their diabetes management. *User must be carb aware. Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields. We have a mission-driven, passionate and collaborative culture where you will have a high degree of empowerment and opportunity to make a significant impact. Please contact us if you fit the profile below and if you are interested in joining the Beta Bionics team! Beta Bionics is seeking a passionate and driven Clinical Diabetes Specialist to join our fast-growing startup. We're revolutionizing diabetes care with the iLet, the world's first closed-loop insulin delivery system with fully autonomous insulin dosing and no requirement to count carbs. In just our first 18 months on the market, we've experienced unprecedented growth-outpacing any other diabetes product launch! Our future looks even more exciting with the development of a patch pump and a bi-hormonal system utilizing insulin and glucagon. This is your chance to get in on the ground floor of an exciting, mission-driven start-up company. If you're a CDCES, interested in working in the industry or have already made a career in the industry, and passionate about healthcare innovation, we'd love to have you on our team. Join us and help shape the future of diabetes care! Summary/Objective: As the Clinical Diabetes Specialist, you are responsible for the promotion and clinical support of Beta Bionics products and services within your assigned geography. You are responsible for managing the training journey for people with diabetes. You will be the main point of contact for the educational needs of the iLet user, healthcare professionals and staff. In partnership with the Territory Business Manager and Inside Sales Specialists, you will develop a targeting and business strategy and develop and maintain strong relationships with our customers. This role requires that you work well in a collaborative environment with the ability to influence cross-functional team success. You must have strong planning and organizational skills with the ability to handle multiple priorities. You will operate with a passion to serve people living with diabetes and our communities. Essential Duties and Responsibilities [Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company's HR contact] Responsible for driving territory goals through strong clinical experience in diabetes Manages, conducts, and supports the training journey for people with diabetes Demonstrates strong teaching and training ability for providers and people with diabetes Will use strong selling skills through a clinical medium Works in conjunction with Territory Business Manager and Inside Sales Specialist to achieve territory goals Maintains compliant communication/documentation with team through Salesforce.com Assists with providing product demos to providers, people with diabetes and families Demonstrates excellent communication and presentation skills Responsible for training the trainer in provider offices Demonstrates empathy with a passion to serve people with diabetes Stands out as a Health Coach - sees the person with diabetes holistically Demonstrates effective planning and organization skills with ability to handle multiple priorities Ability to navigate and influence at all levels within an HCP and IDN environment Required Education and Experience RN or RD CDCES required Acceptable licenses: APRN, NP, PA Minimum requirement of 3 years diabetes experience Preferred Experience and Qualifications 5+ years diabetes experience Preferred industry experience Work Environment and Personal Protective Equipment This is a field-based position. Candidate must reside in the geography specified in the job title Physical Demands While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers This position requires travel depending upon business needs Compensation and Benefits The annual base salary for this position is $90,000 - $110,000, plus an annual commission target, resulting in an annual earnings target of $128,000 - $148,000. Beta Bionics offers a competitive compensation package that includes equity and comprehensive benefit offerings. Beta Bionics offers healthcare benefits for employees and their families including medical, dental, and vision coverage, as well as flexible spending accounts (FSA) and a health savings account (HSA) that includes an annual company contribution. Our comprehensive benefits package also includes a 401k with a generous company match and no waiting period plus immediate vesting, an open PTO policy, and 10 paid holidays per year. Annual base salary will vary based on skills and experience, and may vary depending upon a candidate's location and relevant market data. Equal Employment Opportunity Statement It is the policy of Beta Bionics to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.

Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias. Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions. Our lead drug candidate, Saroglitazar, is a liver-selective, dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA). As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow. RESPONSIBILITIES: - Trial Master File maintenance, auditing, and reconciliation experience. - Serve as the primary responsible party for the management of a Trial Master File (TMF). - Archival of paper files and, if possible, experience auditing archived files. - Meeting agenda and minute-taking experience. - Review and manage Electronic and safety data management systems - Partner with others to work on international clinical trials. - Interact with institutional review boards (IRB). - SOP development. - Calendar management - Expense report completion. - An understanding of the regulatory requirements in the United States, as they pertain to essential documents and SOPs. - Interacting with investigational sites. Requirements QUALIFICATIONS - SKILLS & REQUIREMENTS: - Experience collaborating and interacting with internal and external partners from a variety of cultural backgrounds and geographic locations. (Although note require, familiarity with other languages will be noted.) - Proficient with Windows Office (Word, Excel, and PowerPoint) and Adobe Acrobat. o Excel will be used extensively. Experience with chart development and basic functions are necessary. - Must be well-organized. - Must have excellent verbal and written skills. - Fluent in English. - Some measure of flexibility will be necessary. Due to the international framework of the organization, there will be instances wherein meetings are scheduled during non-traditional workday hours. This usually occurs no more than 2 hours prior to the standard workday. - The ideal candidate must be able to work independently but consistently. - Personal interactions are critical to the role. Must have good relationship skills. EDUCATION & EXPERIENCE: - Minimum of Associate's Degree, Bachelor's Degree preferred. TRAVEL: - Minimal, less than 10% WORK ENVIRONMENT: This is an office-based position, located in our office in Pennington, NJ. The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is: • Frequently required to sit and/or stand, walk, talk, and hear. • Ability to sit at a computer for an extended period of time. • Vision ability requirements include clarity of visions at 20 inches or less due to computer work. • Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic). • Constantly required to use hands and fingers to operate office machines and equipment. • Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch. The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job. Zydus Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Zydus is committed to providing reasonable accommodation to, among others, individuals with disabilities and disabled veterans. If you need an accommodation because of a disability to search and apply for a career opportunity with Zydus, please contact us and let us know the nature of your request.

Job Description About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Clinical Trial Associate (CTA) is responsible for supporting the daily workflow of clinical operations activities. They will provide administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the eTMF and vendors.? Role and Responsibilities: Provides administrative support to the clinical operations study team, including managing meeting logistics, creating agendas, and drafting meeting minutes Executes tasks as assigned by the Clinical Operations Manager, including study budget forecasting and tracking Ensures accurate and timely documentation, including eTMF management, study contracts and financial records in compliance with ICH-GCP, company policies and regulatory requirements Coordinates clinical operations activities across cross-functional teams, including contract management, vendor oversight, site start-up and activation, protocol deviation Creates and maintains study-related materials, such as country and site binders and tracks trial milestones Ensure the eTMF is being maintained up-to-date and all essential documents are appropriately filed in the eTMF Collaborates with CROs to ensure accurate data collection and entry into the CTMS and EDC Attend and contribute to team meetings, taking detailed meeting minutes Supports clinical study management as delegated by Clinical Operations managers, including liaison with external vendors Actively participates in process improvement initiatives to enhance clinical operations efficiency All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's degree in biological sciences, health sciences or medical field, or equivalent combination of education and experience 2+ Years of experience in clinical study environment within CRO or Pharmaceutical company Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out. Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines Ability to organize, prioritize tasks, identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks. Ability to receive general instructions on new assignments and perform routine work independently. Collaborate and work effectively within a team and within a multi-disciplinary environment. Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form Attention to detail, accuracy and confidentiality Critical thinking, problem solving, ability to work independently Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods Work in a fast-paced, demanding and collaborative environment Demonstrate high ethical standards for honesty, truthfulness and integrity The pay range for this role is $97,000-$114,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

Job Description Field Clinical Specialist - (Morristown) Remote/Field role InspireMD is a dynamic growing company focused on developing and commercializing innovative Class III PMA and Class II medical devices. We are seeking a Field Clinical Specialist (FCS) to join our team. In this role, you will be responsible for providing world class training, case planning and support to customers using or interested in using InspireMD products. Reporting to a Regional Sales Director, the FCS will work with Territory Managers (TMs), fellow FCSs and other functions (Training/Commercial Development, Clinical Affairs, etc.) to support customers in both the clinical and commercial settings to support the overall success of InspireMD's launches of CGuard Prime and SwitchGuard. Key Responsibilities: A Field Clinical Specialist is responsible for providing world class training, case planning and support to customers using or interested in using InspireMD products. Support and influence all customer types- (Interventional, Vascular, and Neuro Interventional, supporting both CAS and TCAR procedures to optimize patient outcomes, to include the creation of case plans. Collaborate with RSD and TMs to target and maximize CAS, TCAR and neuro (to include tandem lesion) opportunities, as product approvals and launches allow. Collaborate with commercial development to enhance professional education (physician/customer) programs as requested. Collaborate with Clinical Affairs to provide outstanding case support for clinical trials, as requested. Leverage and build customer relationships to support commercialization/product launch, professional education, and field training efforts. Inspection Support: Support FDA inspections and audits, ensuring that all regulatory and complaint handling documentation is in order and facilitating smooth interactions with regulatory authorities. Qualifications: Minimum of five (5) years of experience in the medical device industry or clinical/patient care, including prior experience with Interventional Cardiology/Radiology/Neurology and/or Vascular Surgery. Prior experience with innovative medical products; Endovascular experience. Educational degree or certification in a business, life sciences or a healthcare discipline.

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

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position The Clinical Program Manager, Oncology, Clinical Study Management, will plan and oversee the execution of clinical trials in oncology and other therapeutic areas, as needed. This role works in close partnership with cross-functional teams to ensure studies are delivered on time and within budget, with a strong focus on quality, operational excellence, and best-in-class clinical study management. The successful candidate will play a key role in driving study execution, managing risks, and enabling high-performance collaboration across functions and regions. This role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology or neuroscience. What You'll Do Develop and own the operational strategy, timelines, and operational plans for clinical trials, ensuring alignment with program objectives and overall business goals. Oversee and lead cross-functional clinical trial execution, leading proactive risk identification, assessment, management, and driving alignment on mitigation strategies. Ensure high standards of quality by overseeing that clinical studies are conducted in accordance with approved protocols, company SOPs, applicable regulations, and maintain ongoing inspection readiness across the program lifecycle. Serve as central point of contact to facilitate cross functional team effectiveness, drive operational efficiency, and provide clear direction and guidance to ensure successful study execution. Work with minimal oversight from the Clinical Study Management Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development, Finance, and Legal functions. Oversee and manage vendor relationships and performance to ensure that clinical studies are completed in accordance with contractual specifications for quality, timelines, and cost. Provide regular, clear updates on study progress, risks, and mitigation plans to stakeholders and executive management (e.g., Clinical Study Management, Project & Portfolio Management, Clinical Research). Ensure that all study-related documents are accurate, complete, and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems in a timely manner. Lead, manage, hire, develop, and mentor global and regional Clinical Study Management personnel. Contribute to improvement initiatives, operational excellence efforts, and cross-functional projects that add value to Eikon Therapeutics. Qualifications Bachelor's degree with 8 years, a Master's degree with 6 years, or a PhD with 3 years of relevant experience in life sciences, healthcare, or related field preferred. Fluency in English (strong reading, writing, and speaking skills with the ability to effectively communicate with colleagues and stakeholders at all levels) is required. In-depth knowledge of ICH-GCP, regulations, directives, and guidelines. Proficiency in clinical trial management systems (CTMS, RTSM (IRT), Veeva Vault suite) and electronic data capture (EDC) systems. Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety. Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams. Experience managing budgets, resources, processes and controls, productivity, quality, and project delivery. High sense of accountability and urgency to prioritize deliverables effectively. Growth mindset and ability to independently. PMP certification preferred. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site The expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This field-based position is based in either New York or New Jersey. Purpose and Scope: A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: Site Selection Pre-trial assessment Site level Study Participant recruitment/retention plans Site Activation/Initiation On-site and remote monitoring Overall site relationship management in collaboration with other sponsor roles that interact with the site Close-out activities Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Responsibilities & Accountabilities: Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. Develops meaningful site relationships through consistent collaborative communication and engagement. May participate in site feasibility and/or pre-trial site assessment visits. Attends/participates in investigator meetings as needed. May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. Ensure ongoing adequacy of site (facilities, staff) for trial conduct. Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. Ensures site non-IMP study supplies are adequate for trial conduct. Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. Oversees the appropriate destruction of clinical supplies. Ensures site staff complete data entry and resolve queries within expected timelines. Ensures validity and completeness of data collected at trial sites. Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. Prepares trial sites for close out, conduct final close out visit. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.

Are you ready to launch a meaningful career in healthcare that directly supports a life-saving mission? At NJ Sharing Network, we're seeking a passionate and driven professional in the Camden or Mercer County area with a bachelor's degree in biology or medical sciences to join our team as a Clinical Donation Specialist. In this rewarding role, you'll help save and enhance lives every day through the gift of organ and tissue donation. If you're ready to embark on a new journey in your career and make a meaningful difference, we invite you to apply today to be part of our life-saving mission! General Summary: The Clinical Donation Specialist is responsible for facilitating the organ and tissue donor process through assessment, authorization, donor management, organ allocation, and surgical recovery. This position supports the mission of NJ Sharing Network to maximize the recovery and quality of organs and tissue for transplantation while maintaining sensitivity, compassion, and respect for people of all cultures. The CDS works with families to provide support, education and approach for organ and tissue donation and functions independently using good clinical judgment and decision making to solve complex problems. This position requires on-call status and is required to work extended period, and overnight shifts. Responsible for all regulatory compliance pertaining to organ and tissue donation. Duties and Responsibilities: Facilitates the organ and tissue donor process through assessment, authorization, donor management, organ allocation, and surgical recovery. Functions independently using good clinical judgment and decision making to solve complex problems. Follows best practice guidelines as outlined by the Network management team. Maintains competency to perform in the role through ongoing education and training. Proficient with onsite evaluations. Responds to donor referrals from local hospitals and ensures that each referral is reviewed for donation suitability. Accurately enters all data related to the donor evaluation into POAP while following best documentation practices. Works with families to provide support, education and approach for organ and tissue donation. Completes authorization/notification and completes medical social history. Huddles with hospital staff to provide guidance, support and education through the brain death and Donation After Cardiac Death processes. Manages the physiology of the donor to ensure maximum viability of organs and tissue for transplantation. Implements donor management standing orders, reviews results of testing and identifies needs for additional management. Allocates organs according to UNOS policies through the DonorNet System. Works with the transplant centers to perform additional donor testing and screening. Coordinates logistics of the Operating Room with all teams involved. Facilitates the organ recovery process in the Operating Room including reviewing documentation according to regulatory agency guidelines, maintains donor stability throughout, completes intraoperative and anatomy paperwork and verifies packaging and labeling of all organs and specimens according to policy. Communicates with funeral home, medical examiner and family upon completion of Operating Room. Maintains clear and effective communications with interdisciplinary teams. Completes chart corrections accurately within defined timeframe to maintain compliance with Network regulatory agencies. Attendance at all-staff, clinical and team meetings as well as case reviews and job specific training are mandatory. Perform other duties as assigned Education and Experience: RN with active license in good standing or a Bachelor's degree in biology or medical sciences required. Experience in trauma/critical care preferred or 1 year of related OPO experience and/or training in a health care/hospital setting preferred. Bilingual: Spanish preferred. Pay Range: Salary: $64,000.00 - $89,500.00 This salary range is based on our market pay structures. Individual compensation is determined by various factors, including but not limited to business needs, local market conditions, internal equity, and candidate qualifications such as skills, licenses, certifications, education, and experience. Benefits Package: NJ Sharing Network offers eligible employees a competitive benefits package including medical, prescription, dental, and vision coverage; flexible spending accounts (FSA); an employee assistance program (EAP); life and disability insurance; paid time off for vacation, sick days, and company-recognized holidays; a 401(k) plan; tuition reimbursement; a transit program; and much more. New Jersey Organ and Tissue Sharing Network (NJ Sharing Network) is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, creed, color, national origin, nationality, ancestry, age. sex/gender (including pregnancy), marital status, civil union status, domestic partnership status, familial status, religion, affectional or sexual orientation, gender identity or expression, atypical hereditary cellular or blood trait, genetic information, liability for service in the Armed Forces of the United States, or disability or any other class protected by Federal, State or Local laws.

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Clinical Study Manager needs 5 years relevant experience is required with a BSc, 3 years with a MS/MPH, or 2 years with PharmD/PhD/MD Clinical Study Manager requires: Phase II/III Oncology trial experience strongly preferred Global trial experience strongly preferred Experience working in both sponsor and CRO organizations strongly preferred Candidates with a nursing diploma/assoc degree with substantial experience may be considered for this position. clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. Clinical Study Manager duties are: Develop project cross-functional, integrated study plan to study start up (in-house) and validate and manage to the overall study implementation plan provided by the CRO. Participate in site selection and site qualification with (study team and CRO). Contribute to operational delivery aspects of the protocol and lead document review & coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Additional Information $57/hr 6 months