Clinical coordinator jobs in Lakewood, NJ - 174 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

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: Howell, 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.

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

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 Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data Creation and development of study trackers Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. Responsible for reviewing assigned study related plans, processes, agreements, and guidelines Following and implementing assigned study related plans, processes, agreements, and guidelines Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met Reviews and approves essential document packages to enable timely site activations. Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Ensures the study is “inspection ready” contemporaneously Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred A minimum of 3+ years of clinical research experience in conducting clinical trials Prior phase II or III experience required A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Experience with clinical studies oncology and / or rare diseases a plus Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) Tenacity to work in a fast-paced team environment Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships Ability to successfully engage and work collaboratively with global team members/colleagues Ability to support building and delivery of patient enrolment strategies Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives. Ability to review and assess clinical data Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills 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.

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

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 The Clinical Research AssociateCRAisresponsible for Supporting all aspects of Clinical Trial Management for complex global studies from study planning and start up through study close out This role will collaborate withfunctional team members CROsand vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or DirectorThe CRAis responsible foradherenceto all performance metrics and quality of deliverables in the clinical trial Role and Responsibilities Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained remain current with project requirements and have a thorough understanding of study milestones and deliverables Reviewapprovetrack vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high quality data Creationand developmentof study trackers Develop and provide clear complete documentation of study specific meetings actionitemsand action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including but not limited to consent documents site welcome packets study binders etc Responsible for reviewing assigned study related plans processes agreements and guidelines Following and implementing assigned study related plans processes agreements and guidelines Responsible for requesting and logging CRO and vendor RFIs RFPs contractswork orders and specifications to enable studyobjectivesto be met Reviews and approves essential document packages to enabletimelysite activations Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol and proactively addresses conduct issues andenrollmentproblems as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study Perform periodic QC of the TMF Oversee the execution of clinical trial activitiesin accordance with Good Clinical Practices Ensures compliance of clinical trials with national regulatory requirements and co monitoring the assigned clinical trial following company SOPs Ensures the study is inspection ready contemporaneously Responsible for supporting functional activities of Clinical Trial Associatesallocatedto the project through leadership and training as indicated and appropriate All other duties as assigned Experience Education and Specialized Knowledge and Skills Bachelors degree or equivalent in life science nursing pharmacy medical laboratory technology or other healthmedical related area preferred A minimum of 3years of clinical research experience in conducting clinical trials Prior phase II or III experiencerequired A solid understanding of the recruitment methods drug development process ICH guidelines GCP and specifically each step within the clinical trial process Experience with clinical studies oncology and or rare diseases a plus Sophisticated understanding and highlyskilfulutilizationof Microsoft Apps such as Outlook Word Excel and Teams Ability to travel internationally to visit clinical sites and for study meetings Amount will vary upon project needs up to 20 Tenacity to work in a fast paced team environment Enjoys building relationships with KOLs and site personnel Willing to travel toestablishrelationships Ability to successfully engage and work collaboratively with global team memberscolleagues Ability to support building and delivery of patientenrolmentstrategies Excellent interpersonal anddecision makingskills Demonstrates innovationpossessesdriveenergyand enthusiasm to deliver the programobjectives Ability to review and assess clinical data Possesses excellent planning time management & coordination skills Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements interactions with external parties timelines and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills 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

SpecialtyCare is expanding! We are currently looking for the right candidate to start and train as a Minimally Invasive Clinical Specialist I (MIS) to work in and around the Operating Room. SpecialtyCare provides multi-stage training programs involving personalized, hands-on learning from in-person educators, training in a high-class simulation OR, and learning different sterilization, packaging, and troubleshooting techniques - all of which is paid and all-expenses covered! We are interested in individuals who have experience delivering excellent customer service and enjoy working in a fast-paced, hands-on, detail-oriented environment. This role does NOT have direct patient care, however this person will be supporting the laparoscopic and endoscopic surgical teams directly, impacting patients by prepping instruments and equipment to be used in these surgical procedures. As a Minimally Invasive Clinical Specialist I, you will be trained to impact the efficiency of the OR by: * Providing logistical and technical support for laparoscopic and endoscopic surgeries * Setting up, troubleshooting and maintaining all minimally invasive equipment; including video systems/viewing towers before, during and after surgeries and provide troubleshooting support when necessary * Manage single routine procedures to include all tower functions, pre-operative set up, knowledge and application of instrumentation at the hospital * Understand the functionality and connectivity of all video components, along with troubleshooting principles * Assist and interact with physicians and other clinical staff members as requested to ensure all preferences are met * Complete all appropriate paper and electronic documentation forms. * Ensure that supplies are stocked and available as needed. * Sterilizing and decontaminating equipment and instruments at the end of each case, preparing equipment for the next case and appropriately disposing of all refuse * Participate in shadow and/or tray call coverage assignments as scheduled * Learn and adhere to all required policies, procedures, and clinical guidelines of SpecialtyCare and our partnered hospitals and facilities * Lives the SpecialtyCare Values - Integrity, Care, Urgency, and Improvement. * Perform other duties as assigned. Requirements: * High school diploma or G.E.D. equivalent, required. * Associate or bachelor's degree preferred * Cardiopulmonary resuscitation (CPR) certification, preferred. * Heatlhcare experience or training, preferred. * Equivalent combination of education and experience, acceptable. * Must live within 30 minutes of our contracted hospitals * Ability to work flexible hours and participate in a call rotation including weekends/nights/holidays * Reliable transportation * Must be able to successfully complete a pre-hire medical aptitude test, on the job training including certification and company required education modules The Successful Candidate The ideal candidate demonstrates the following: * A high level of ethical, intellectual, professional and personal values which complement the team and company vision. * Ability to thrive in a fast-paced environment, displaying a sense of urgency * Dedication to consistently delivering exceptional customer service * Excellent communication skills * Basic computer skills * Ability to adapt and succeed in a high stress environment * A self-starter who works well both independently and in a team Benefits SpecialtyCare provides a comprehensive benefits package including health, dental and life insurance, a matching 401K and generous PTO plan. Costs incurred for required professional licensures and certification are reimbursable. SpecialtyCare is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. SC MISS

Clinical Research Associate Marlton, NJ Hope is Here! Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company's Optimizer Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany. The Clinical Department is responsible for executing clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines. Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within Impulse Dynamics. In this way, the department serves as a cross-functional liaison and creates a positive, collaborative team environment with an eye toward innovation and operational excellence. You will be joining a team that is committed to meaningfully advancing the science of heart failure treatment for a global community of patients and their healthcare providers. How You'll Add Value * Manage and organize all administrative aspects for assigned clinical trials, including creation and maintenance of site personnel contact information, mass mailings, study regulatory documents, and electronic or binder preparation for distribution. * Assist the CTM with overseeing the monitoring visit scheduling and monitoring report review * Prepare CST meeting minutes. * Act as a resource for the clinical sites and research monitors for the trial. * Assist with training of site staff who are working on the study. * Collect regulatory documentation and ensure accuracy. Record the receipt of all key study documentation and contact site regarding missing records. * Review various study-related tracking systems to determine and report the status of clinical trial documents. * Collect outstanding documents by contacting the clinical trial sites or working with the field monitors. * Send notifications to the clinical trial sites regarding their IRB renewal dates. * Maintain and audit all study-related files in compliance with department standard operating procedures. * Assist with the follow-up and resolution of noted observations on audit and monitoring reports. * Work with the clinical trial sites to ensure all required testing is forwarded to and received by the Core Laboratories. * Ensure consistent use of study tools and training materials and compliance with standard operating procedures and policies. * Make all the arrangements for periodic meetings, such as Physician Adjudication Committees, Data Safety Monitoring Boards, and Monthly Webcast meetings, and assist the Clinical Trial Manager with the preparation of the meetings. * Review and approve Site Qualification Reports for new clinical trial sites * Train users on the EDC/case report forms and other systems that may be used (i.e., electronic regulatory Binders). * Maintain the CTMS for site budgets and payments in accordance with the scheduled budget for each clinical trial site agreement. Ensure invoices are reviewed and approved on a timely basis and submitted to accounting for payment. What You're Bringing with You * 1-2 years of clinical research experience with a bachelor's degree and/or * 4 years of clinical research experience with professional certification (CCRP, ACRP) * Experience with communicating with hospital administrators, research nurses, and study coordinators. * Working knowledge of FDA regulations, Good Clinical Practices (GCPs), and all applicable state, local, and federal regulatory requirements. * Experience with IBM EDC, ClinPlus CTMS, Florence e-Binders, Egnyte, and/or other eRegulatory solutions. * Medical device and/or heart failure clinical trials experience preferred. * Bachelor's degree in life sciences or related field preferred or equivalent work experience. Our commitment to you Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that's enjoyable, thorough, and fair. That's our way of inspiring the innovative brightest minds. Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around the diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference. Annual Base Salary Range: $ 60,000 - $ 75,000 * Full Coverage Medical Benefits - Employee + family contribution is 100% covered by Impulse Dynamics. * Paid Vacation, floating holidays, and sick time. * Paid Holidays * 401k Match (up to 6%) * Annual bonus eligibility Unless specifically indicated communicated otherwise in writing, all employees are "at-will" employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee's employment. Equal Opportunity Employer Statement: Impulse Dynamics is an equal opportunity employer. Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

Country: United States of America Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: This job requires a U.S. Person. A U.S. Person is a lawful permanent resident as defined in 8 U.S.C. 1101(a)(20) or who is a protected individual as defined by 8 U.S.C. 1324b(a)(3). U.S. citizens, U.S. nationals, U.S. permanent residents, or individuals granted refugee or asylee status in the U.S. are considered U.S. persons. For a complete definition of “U.S. Person” go here. ********************************************************************************************** Security Clearance: None/Not Required Pratt & Whitney is working to once again transform the future of flight-designing, building and servicing engines unlike any the world has ever seen. And because transformation begins from within, we're seeking the people to drive it. So, calling all curious. Come ready to explore and you'll find a place where your talent takes flight-beyond the borders of title, a country or your comfort zone. Bring your passion and commitment and we'll welcome you into a tightknit team that takes our mission personally. Channel your drive to make a difference into shaping an organization and an industry that's evolving fast to the future. At Pratt & Whitney, the difference you make is on display every day. Just look up. Are you ready to go beyond? What You Will Do: The Cold Section Module Center (CSMC) produces Compressor and Turbine Rotors, Drums, Disks, Hubs, Fan Cases, and Fan Blades for multiple commercial and military engine programs. Cold Section is the Center of Excellence for the manufacturing and inspection of Integrated Blade Rotors (IBR) for the F119, F135 and Next Generation Product Family (NGPF). The Cold Section Quality Clinic is a challenging, fast paced, high visibility environment. The CSMC Quality Clinic Manager will lead by influence while reporting to the Cold Section Quality Clinic Manager. Coordinate the Escape Management Process for escapes, including population bounding, identifying robust systemic root cause and follow up on the implementation of corrective/preventive actions Facilitation and coaching of cross functional Problem Resolution Team (PRTs) for escapes and Clinic Assists for high pain organizational issues Foster and maintain cooperative relationship with Program Quality, Product Recall, DCMA, and leverage clinic to clinic interaction across PW enterprise Improve RCCA (Root Cause Corrective Action) proficiency throughout assigned organization Drive personal improvement in RCCA competency Maintain Quality Clinic and individual certifications Support the maintenance of all Clinic Metrics Maintain CORE (Customer Oriented Results and Excellence) discipline and certification Qualifications You Must Have: Bachelor's degree and 10 or more years' experience in an engineering, manufacturing operations, quality or similar industrial environment OR a Master's degree and 7 or more years' experience in an engineering, manufacturing operations, quality or similar industrial environment Proficiency in Microsoft Office products (Word, PowerPoint, Excel) Knowledge of non-conforming material management processes Knowledge of RCCA tools and proficiency in driving robust systemic RCCA Experience in a lead/supervisory/management capacity Qualifications We Prefer: Master's Degree Knowledge of SAP and Quality Notifications Familiarity with the 8D process Experience working in a shop capacity Aerospace industry experience Experience developing and executing action plans, influencing decisions and driving change Learn More & Apply Now: In addition to transforming the future of flight, we are also transforming how and where we work. We've introduced role types to help you understand how you will operate in our blended work environment. This role is: Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance workers, as they are essential to the development of our engines. As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote. The salary range for this role is 124,000 USD - 250,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Privacy Policy and Terms: Click on this link to read the Policy and Terms

Why Join Us? For us, what matters most is excellence. We are caring professionals, people who live, work and dedicate themselves to the communities within New Jersey and Pennsylvania. As such, we strive to provide a sanctuary of excellence, precision, thoroughness and genuine compassion. We also take a whole-person approach to patient care and treatment, tailoring all that we do around their unique needs. And we do all we can for patients, going the extra mile to see that they're supported, informed and getting the one-on-one care and service they deserve. Job Description: As an Oncology Clinical Research Assistant (CRA), you will be assisting team members at Astera Cancer Care on recruiting participants, collecting and managing the study data for the successful management of clinical trials. This is a full-time position. Responsibilities Include: Assisting Clinical Research Coordinator (CRC) to ensure that clinical research activities are performed in accordance with local and federal regulations and adhere to policies and procedures of Astera and the sponsors and CROs Assisting CRC on the coordination of tests and visits for patients and maximizing work efficiency and productivity. Assisting Regulatory Specialist (RS) on IRB submissions and interact to maintain regulatory documents and administrative files for each protocol. Assisting CRC on confirming patient's eligibility into clinical trials. Assisting Clinical Data Coordinator (CDC) and RS on maintaining patient and regulatory research records. Confer with all members of the clinical team to confirm appropriateness and timeliness of tests. Collect follow-up data on patient's post-treatment as required by the protocol. Assisting CDC on entering research data into a centralized database as per protocol requirements. Prepare other study materials as requested by the Principal Investigator such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs. Qualifications: A Bachelor's degree preferred. Experience with Microsoft applications. Able to travel between offices within the offices in Northeast Jersey area. Excellent communication skills. Excellent time management skills.

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

Job DescriptionSystImmune 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. We are seeking a motivated Clinical Research Associate (CRA) to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements. This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers. Responsibilities Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits. Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries. Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts. Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders). Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned. Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy. Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level. Qualifications Bachelor's degree in health sciences or related field. 1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC). Exposure to oncology trials. Knowledge of ICH-GCP guidelines and regulatory requirements. Strong organizational skills, attention to detail, and ability to work both independently and within a team. Willingness to travel regionally (approx. 50%-75%). Preferred 1-5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role. Someone who has supported Phase I or oncology studies or is eager to grow into that space with guidance. Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight. Compensation and Benefits: The expected base salary range for this position is $60,000 - $90,000 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 align strongly with 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. Powered by JazzHR jZ3XHqOc1X

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. We are seeking a motivated Clinical Research Associate (CRA) to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements. This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers. Responsibilities * Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits. * Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries. * Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts. * Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders). * Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned. * Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy. * Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level. Qualifications * Bachelor's degree in health sciences or related field. * 1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC). * Exposure to oncology trials. * Knowledge of ICH-GCP guidelines and regulatory requirements. * Strong organizational skills, attention to detail, and ability to work both independently and within a team. * Willingness to travel regionally (approx. 50%-75%). Preferred * 1-5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role. * Someone who has supported Phase I or oncology studies or is eager to grow into that space with guidance. * Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight. Compensation and Benefits: The expected base salary range for this position is $60,000 - $90,000 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 align strongly with 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.

Passionate, driven people dedicated to making a difference in healthcare. SpecialtyCare continues to grow and we'd like you to grow with us. Our clinicians and technicians participate in over 350,000 surgeries each year in 45 states, the District of Columbia, and Puerto Rico. We serve more than 1,000 hospitals and support more than 13,000 surgeons. By participating in such a large number of surgeries and by working with world-class surgeons, we are the most experienced provider of outsourced clinical services in the industry. We are always interested in building our team by hiring and training smart, dedicated people who share our values and our commitment to excellence. Our minimally invasive surgical support (MISS) teams play a vital role in the operating room by providing surgeons with the correct instruments that they need to perform procedures. Job Summary As a Clinical Manager, Minimally Invasive Surgical Support, you are responsible for leading and managing the day to day efforts of the minimally invasive team at your facility. It is your responsibility to ensure client satisfaction while also adhering to the highest quality and compliance standards. You will take an active role in assembling the surgical trays to each surgeon's unique preference and ensure that each instrument meets our high quality standards, working alongside the Clinical Technicians. * Assure that the standards of operation of the department comply with the standards set by regulatory agencies, such as the state Department of Health, Joint Commission and other regulatory agencies. * Manage all staff to include scheduling, time approval, hiring and corrective action as needed. * Provides a comprehensive departmental orientation to all new personnel and ensure existing staff receives training on an ongoing basis. * Develops and implements departmental performance improvement activities and assures ongoing staff participation. * Establishes internal inventory levels and maintains levels in accordance with set standards and in coordination within using units within the hospital; establishes par level stocks and monitors them for proper utilization. * Establish/maintain a preventative maintenance program for equipment in coordination with appropriate departments within the hospital. * Provides instructions and in-service in new products, procedures and equipment in a manner that will identify and prevent resource loss and maintain safety. * Responsible for implementing and reinforcing SpecialtyCare's Vision, Mission and Values. * Meet regularly with SpecialtyCare regional management team to discuss any issues, successes and opportunities to provide better service to clients. * Performs other duties and works on special projects as assigned. Requirements * Associate's Degree or equivalent, preferred. * Three years of management experience in a clinical setting. * Must have the ability to teach and have demonstrated ability in written and oral communications and interpersonal skills. The Successful Candidate The successful candidate must bring a high level of ethical, intellectual, professional and personal values that complement the team and company vision. The following competencies are highly valued: * Strong relationship builder with exceptional interpersonal skills that can influence perceptions, decisions and actions of others through effective communications both within the organization and externally. * Proven self-starter who works well both independently and in a team environment. * High energy, self-motivated individual whose style is effective in working with all levels of the organization to drive performance and continuous improvement using an analytical and metrics based approach. * Ability to effectively review and synthesize medical literature for the purpose of writing clinical procedure guidelines, clinical policies and peer review scientific publications. * Works well in a fast-paced environment and with a sense of urgency. * Lives the SpecialtyCare Values - Integrity, Care, Urgency, and Improvement. Benefits SpecialtyCare is committed to supporting professional growth for our associates. Each associate is allocated funds for continuing education, membership fees, and dues for professional associations. We also provide tuition reimbursement or tuition repayment assistance. We provide a full benefits package including a matching 401K and generous PTO plan. We also cover the cost of maintaining certification. SpecialtyCare is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. SC MISS

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 Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data Creation and development of study trackers Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. Responsible for reviewing assigned study related plans, processes, agreements, and guidelines Following and implementing assigned study related plans, processes, agreements, and guidelines Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met Reviews and approves essential document packages to enable timely site activations. Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Ensures the study is inspection ready contemporaneously Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred A minimum of 3+ years of clinical research experience in conducting clinical trials Prior phase II or III experience required A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Experience with clinical studies oncology and / or rare diseases a plus Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) Tenacity to work in a fast-paced team environment Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships Ability to successfully engage and work collaboratively with global team members/colleagues Ability to support building and delivery of patient enrolment strategies Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives. Ability to review and assess clinical data Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills 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.

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. We are seeking a motivated Clinical Research Associate (CRA) to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements. This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers. Responsibilities Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits. Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries. Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts. Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders). Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned. Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy. Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level. Qualifications Bachelor's degree in health sciences or related field. 1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC). Exposure to oncology trials. Knowledge of ICH-GCP guidelines and regulatory requirements. Strong organizational skills, attention to detail, and ability to work both independently and within a team. Willingness to travel regionally (approx. 50%-75%). Preferred 1-5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role. Someone who has supported Phase I or oncology studies or is eager to grow into that space with guidance. Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight. Compensation and Benefits: The expected base salary range for this position is $60,000 - $90,000 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 align strongly with 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.