Clinical research coordinator jobs in Warren, NJ - 288 jobs

Commonpoint is seeking to hire an HSE Coordinator for the Advance & Earn Program at its Bronx Center. The goal of the Advance & Earn Program is to provide a career pathway for opportunity youth through a continuum of services including literacy and math facilitation, HSE test preparation, work readiness training, college and career exploration, paid work experience, advanced occupational training, and industry credential attainment. The programs support opportunity youth at any educational level, providing on-ramps at various levels through three program components, each supported by case management and wrap-around services. DUTIES AND RESPONSIBILITIES: The HSE Coordinator will: ● Develop lesson plans according to the various learning styles of program participants. ● Facilitate groups with the goal of improving literacy skills. ● Identify ways to connect classroom learning with real-world applications, ensuring that participants understand how to apply skills in workplace environments. ● Coordinate with program staff to ensure that participants' progress is being appropriately tracked and supported. ● Continually assess student progress toward mastery of standards and keep students and staff well informed of student progress by collecting and tracking data, providing daily feedback and weekly assessments. ● Provide necessary accommodations and modifications for the growth and success of all students. ● Attend professional development workshops and learning communities that will discuss RLA and Social Studies subtests, as well as curriculum development for the GED exam. ● Administer and utilize standardized assessments to develop curricula targeting the educational challenges of the students. ● Monitor students' performance and attendance for required reporting systems. ● Assist in the evaluation of participant engagement and curriculum effectiveness. ● Collaborate with case managers and program leads to ensure participants' holistic success in the program. ● Maintain flexibility to support program and agency-wide goals as needed ● Implement strategies to maximize student retention. QUALIFICATIONS & REQUIREMENTS: Required & Preferred Qualifications ● Bachelor's Degree in Education or comparable field required. ● Minimum of two years of experience overseeing young adult learners of varied ages, levels, and diverse cultural backgrounds. ● Knowledge of ABE and GED curricula, testing procedures, and requirements. ● Demonstrated ability in youth development WORKING CONDITIONS ● Participation in all staff meetings and staff training seminars. ● Participation in agency-wide programs and program committees, as assigned. ● Active involvement as a supervisee in the supervision process. ● Support the mission of Commonpoint. ● Other tasks appropriate to the Commonpoint staff, as assigned. BENEFITS AND PERKS The benefits package includes comprehensive health, vision, and dental insurance, along with life insurance and a pension plan. Employees can take advantage of a flexible spending account and commuter benefits to help manage expenses. Paid time off (PTO) and floating holidays provide flexibility for personal time and work-life balance. The agency also offers a voluntary 403(b) retirement plan for additional financial security. Employees can enjoy various agency perks, including access to fitness centers, pool clubs, and discounts on agency programs. Additionally, the agency supports professional development through a scholarship program and a mentorship program. JOB DETAILS Annual Salary: $50,000 - $55,000 Non-Union Position Location: Commonpoint Bronx Center, 1665 Hoe Ave, Bronx, NY 10460 How to Apply Send resume and cover letter to Zachary Smith at **********************

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.

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.

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

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description CORE JOB RESPONSIBILITIES: Assist the Clinical Research team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data. Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). Assist with clinical study report preparation to include narrative writing Participate in adhoc meetings Qualifications KNOWLEDGE/SKILLS/ABILITIES (KSA's): Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years' experience in clinical research development or equivalent Oncology experience REQUIRED. Hematology experience is a plus. Protocol authoring is a plus. Data review and medical monitoring of data REQUIRED. Minimum 5 yrs experience in oncology clinical development Excellent written and verbal communication skills and interpersonal skills. Knowledge of clinical trial design, basic statistics, and data review tools Proficient at data interpretation Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions Full understanding GCP and ICH Guidelines Detail-oriented, well-organized Ability to assimilate technical and scientific information quickly Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave) Demonstrated ability to work as part of a team Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP! I look forward to hearing from you!

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 MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization • MS: 3 to 5 years of clinical development/clinical trial management • BS: 5 to 8 years with industrial or CRO clinical experience Experience in writing clinical portions of regulatory dossiers highly preferred • Knowledge of drug development (all clinical research process including protocol and case report form design, etc) • Knowledge of GCP/ICH guidelines and FDA regulations Additional Information $60/hr 12 MONTHS

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

Job Description WHY VITALIEF? Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. We are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients' mission to impact and save lives. Reasons to work for Vitalief: You can actively contribute to our clients' mission of advancing scientific discoveries that have the potential to change patients' lives for the better. Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees. We give everyone a seat at the table - we encourage innovation. Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually. Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from. Salary Range: Market competitive - based on experience level. Work Location: New Brunswick, NJ. Four (4) days on-site and one (1) day remote on a weekly basis. Responsibilities: Under supervision of clinical research leadership staff, the medical staff, and in collaboration with research nurse staff, performs protocol-specific tasks including patient screening, ordering tests, collecting specimens and study documentation of patient reported responses, relative to various Phase 1 Oncology trials. Serves as a liaison (Communicating effectively) between the organization, investigators, members of the research team (i.e., physicians, nurses, hospital, and laboratory staff), and the research sponsors - to ensure that services are coordinated and delivered to patients in a timely manner. Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Oncology trials. Participates in site preparation for trials including protocol feasibility, preliminary study budget, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents, study documents and forms. Schedules and conducts trial visits by informing patients and coordinating procedures per protocol. Assesses and triages study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol. Assists patients in understanding their diagnosis, treatment options, and the resources available including educating eligible patients about appropriate clinical research studies and technologies. Required Skills: Bachelor's Degree required. Minimum of 2 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol. Oncology clinical research experience is a huge plus. Phase 1 clinical research experience is a plus. Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines. Compassionate personality and ability to interact with patients in a clear and confident manner. Ability to work on several trials concurrently - can demonstrate versatility, “can do” attitude, and possess strong organizational, time management and prioritization skills. Ability to work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner. Needs to be communicative and responsive and know when to escalate and communicate issues to management. Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently. Must have strong Microsoft Office skills. Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR 7Th8KZOkPJ

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us. Hybrid Employee Value Proposition: At Taiho Oncology, we are dedicated to transforming the landscape of cancer treatment and improving patients' lives. As an Associate Director, Clinical Research Scientist, you will play a pivotal role in our mission, leveraging your expertise to drive innovative clinical research and contribute to groundbreaking therapies. We offer a collaborative and inclusive work environment where your ideas and contributions are valued. Join us to advance your career, work with passionate and skilled professionals, and make a meaningful impact on the fight against cancer. At Taiho Oncology, you will find purpose, growth, and the opportunity to be at the forefront of cancer research. Position Summary: The Associate Director, Clinical Research Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3. Additionally, this role serves in assisting the responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, as needed. Performance Objectives: Uses medical/scientific expertise to support the creation of relevant clinical documents of high quality such as study concepts, study protocols, amendments, study reports and investigator brochures. At the asset level, assists the medical lead in the preparations of the clinical content of regulatory submissions/documents (e. g. NDA, MAA, IND, CTA. sNDA, DSUR, PIP, health authority/ethics committee responses, briefing packages). Works with the medical lead to prepare presentations (internal and external), abstracts, manuscripts. Inputs into the of ICF/reviews ICF. Works with data management on CRF design and completion guide. Partners with data management to develop data review plan for review of data and with medical lead for the medical monitoring plan. Reviews protocol deviations, patient eligibility, and patient level and cumulative data per the data review plan across a study, raises queries and coordinates with the medical lead. Reviews safety data with the medical lead, SAE reports (in collaboration with pharmacovigilance), labs, efficacy data, dosing data, withdrawals/discontinuations. Collaborates with the medical lead to provide medical/scientific guidance during the execution of the study. Ensures TMF compliance for clinical development/medical study level TMF documents. Answers specific site protocol questions as needed, after consultation with the medical lead. Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, vendor / CRO staff, in collaboration with the medical lead. Escalates protocol-related issues requiring complex medical expertise to the medical lead, and operational issues to the appropriate operations study team member. Reviews the SAP and statistical outputs, in collaboration with the statistician, medical writer, and medical lead. Education/Certification Requirements: PhD, PharmD or other related Advanced Medical Scientific Degree. Experience in oncology is a must. Knowledge, Skills, and Abilities: At least 3 years in drug development industry in oncology and with previous exposure to clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents. Ability to critically review and interpret Clinical data. Working knowledge of the drug development process in the USA and EU is required. Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members. The pay range for this position at commencement of employment is expected to be between $213,350 - $251,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #LI-Hybrid

Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

Study Participants Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world. Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills. The role We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects. Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter. What you'll bring A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable) A willingness to take our screening to assess your suitability for our participant pool Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time A reliable and fast internet connection and access to a computer A willingness to self-declare your earnings, as our participants are self-employed A Paypal account to receive payment from our clients What you'll be doing in the role Completing paid research studies such as answering surveys, participating in experiments, and providing written responses Providing feedback, judgements, and opinions in structured research tasks Contributing to high-quality research outcomes by responding thoughtfully and accurately Key study types Surveys and Questionnaires Behavioural Experiments User Research and Product Feedback Educational and Academic Studies Interviews and Open-Ended Responses Quality Checks and Attention Tasks Why Prolific is a great platform to join as a Participant Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home. We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines. We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity. Links to more information on Prolific Website Youtube Privacy Statement By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.

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. 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. Powered by JazzHR 48DxHpXuU1

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description CORE JOB RESPONSIBILITIES: Assist the Clinical Research team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data. Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). Assist with clinical study report preparation to include narrative writing Participate in adhoc meetings Qualifications KNOWLEDGE/SKILLS/ABILITIES (KSA's): Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years' experience in clinical research development or equivalent Oncology experience REQUIRED. Hematology experience is a plus. Protocol authoring is a plus. Data review and medical monitoring of data REQUIRED. Minimum 5 yrs experience in oncology clinical development Excellent written and verbal communication skills and interpersonal skills. Knowledge of clinical trial design, basic statistics, and data review tools Proficient at data interpretation Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions Full understanding GCP and ICH Guidelines Detail-oriented, well-organized Ability to assimilate technical and scientific information quickly Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave) Demonstrated ability to work as part of a team Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP! I look forward to hearing from you!

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 MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization • MS: 3 to 5 years of clinical development/clinical trial management • BS: 5 to 8 years with industrial or CRO clinical experience Experience in writing clinical portions of regulatory dossiers highly preferred • Knowledge of drug development (all clinical research process including protocol and case report form design, etc) • Knowledge of GCP/ICH guidelines and FDA regulations Additional Information $60/hr 12 MONTHS

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 3+ years of clinical research experience Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description Responsibilities will include, but are not limited to, the following: 1. Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. 2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc. 3. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). 4. Clinical study report preparation 5. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc. 6. Participate in Development Planning for assigned compounds. 7. Oversee and challenges the adequacy of planning for study implementation 8. In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals 9. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects 10. Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety) 11. Collaborates and supports operational activities as need be. 12. Assist in establishing project budgets 13. Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data. 14. Participate and present at investigator meetings 15. Participate in adhoc meetings (e.g. marketing) 16. Assist in document template design and SOP writing 17. Participate on various corporate committees 18. Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required 19. Lead team meetings as required Qualifications Qualifications Prerequisite : Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), Skills/Knowledge Required: • Minimum 2 yrs. experience in medical or technical writing • Clinical monitoring experience preferred • Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization. • Extensive medical/scientific and clinical research knowledge • Knowledge of Medical Terminology • Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics • Proficient at data interpretation • Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions • Experience in all aspects of the drug development process • Knowledge of GCP and ICH Guidelines • Experience in presenting at Investigator Meetings • Detail-oriented, well-organized • Limited travel required • Ability to assimilate technical and scientific information quickly • Clinical project management skills • Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus • Demonstrated ability to work as part of a team • High level of interpersonal and communication skills (written and verbal) Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP! I look forward to hearing from you!

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

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 Lead Clinical Research Associate needs: BS/BA, MS is desirable 5+ years of site management of which a minimum of 2 years field monitoring experience Knowledge of applicable standards and regulations for clinical trial Experience in Cardiovascular Therapeutic area IVD Stud Experience Medidata RAVE system Lead Clinical Research Associate duties: Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL). Additional responsibilities include: Implementation of enrollment and recruitment strategies Assistance in vendors' selection processes • Additional Information $45/hr 12 months