Clinical research associate jobs in Piscataway, NJ - 295 jobs

About Us Specialty PharmaSource LLC, based in Denville, NJ, is a U.S. wholesale distributor supporting the global healthcare and pharmaceutical sector. We specialize in sourcing FDA-approved branded and generic medications, Comparator Drug Products, and Reference Listed Drugs (RLDs), and in providing clinical trial support services including cGMP packaging, labeling, storage, and global distribution. We work with pharmaceutical and biotechnology companies, CROs, research institutions, and healthcare partners to deliver reliable, compliant, and timely clinical and commercial supply solutions. The Opportunity We are seeking an Associate, Clinical Trial Supply Services to join our growing startup team. This is an early-career role (0-2 years experience) designed for candidates interested in building hands-on expertise in clinical trial supply operations, comparator and RLD sourcing, and global clinical logistics. This position offers broad exposure across sourcing, documentation, packaging, labeling, and distribution activities, with mentorship from experienced professionals and meaningful responsibility from day one. Key Responsibilities Support clinical trial supply operations, including sourcing of RLDs, comparator drugs, and clinical supplies/ancillaries Assist with procurement and coordination of clinical ancillaries such as diluents, devices, kits, and consumables per protocol requirements Coordinate cGMP packaging, labeling, storage, and domestic and international distribution activities Work with suppliers, logistics partners, and internal teams to support timely and compliant execution Maintain accurate documentation, inventory records, and shipment tracking in accordance with cGMP, GDP, DSCSA, and clinical trial requirements Support client communications related to order status, availability, and timelines Assist with proposal preparation, pricing support, and operational documentation Contribute to process improvements and support the growth of a startup environment Qualifications Bachelor's degree in life sciences, pharmacy, supply chain, or a related field preferred 0-2 years of experience in pharmaceutical operations, clinical trials, logistics, or supply chain (internships and co-ops welcome) Strong organizational skills and attention to detail Good written and verbal communication skills Ability to learn quickly, take initiative, and work in a fast-paced startup environment Interest in clinical trials, pharmaceutical sourcing, and global supply chains To apply or learn more, please contact us at: ******************************

Principal Consultant- Clinical Trial Supply Management for Manufacturing, Packaging and Distribution Infosys Consulting is seeking smart, self-driven, high-energy professionals with strong communication skills, intellectual curiosity, and a deep passion for Clinical Trial Supply Management (CTSM) in the Life Sciences domain. The ideal candidate brings a strong blend of domain expertise in clinical supply operations, manufacturing, packaging, labeling, and distribution, along with business transformation consulting experience and excellent stakeholder management skills. This role will play a pivotal part in shaping the next generation of AI-enabled CTSM solutions, where intelligent, autonomous, and goal-driven AI agents proactively plan, optimize, monitor, and orchestrate end to end clinical supply operations. As a Principal Consulting professional, you will leverage your extensive professional services experience to lead large-scale transformations and help mature Infosys Consulting's CTSM and Life Sciences capabilities. You will collaborate closely with pharmaceutical and biotech clients to deliver AI-led business and digital transformations, while contributing to strategic initiatives such as thought leadership, capability incubation, and knowledge management, enabling clients to navigate the evolving global clinical research landscape. RESPONSIBILITIES Be responsible for the delivery of measurable business outcomes for leading pharmaceutical and biotechnology clients, with a focus on manufacturing, packaging, labeling, and distribution of clinical trial supplies. Provide strategic leadership and thought partnership on AI-led transformation programs, reimagining CTSM operating models across demand forecasting, supply planning, production scheduling, and distribution execution. Drive the design and deployment of intelligent CTSM solutions, leveraging autonomous AI agents for Predictive demand and supply planning, Scenario-based manufacturing and packaging optimization. Partner with technology and data teams to conceptualize and implement AI use cases across CTSM, including self-learning agents that continuously optimize Batch sizing and manufacturing runs. Enable clients to transition from reactive, rule-based planning to autonomous, goal driven supply ecosystems that adapt in real time to protocol amendments, enrollment variability, and geopolitical disruptions. Execute consulting engagements within a global delivery model, collaborating with cross-regional and cross-functional teams as part of a high-performing consulting community. Lead complex, multi-vendor and multi-stakeholder programs spanning clinical operations, supply chain, quality, IT, and external partners. Act as a trusted advisor to senior client stakeholders, influencing decision-making through data-driven insights and future-state visioning. Mentor and coach consulting team members through both formal performance management processes and ongoing informal feedback. Contribute to the growth and reputation of Infosys Consulting by developing new CTSM and Agentic AI-led offerings, authoring whitepapers, point-of-view documents, and thought leadership articles. Participate actively in firm-building initiatives, community events, and internal knowledge-sharing forums. BASIC QUALIFICATIONS Bachelor's degree or foreign equivalent required. Will also consider three years of progressive experience in the specialty in lieu of every year of education. Overall experience of 7+ years, with at least 3+ years of post-MBA consulting experience in clinical manufacturing and operations with Lifesciences clients. Experience in leading CTSM engagements for Life Sciences clients. Strong understanding of Clinical Trial solutions in the value chain area of Study Master Design and Forecasting/Planning In depth understanding of managing clinical operations using IxRT (Interactive Response Technology) Experience in developing proposals, building tools and accelerators for CTSM related services. Ability to handle conversations with senior business and technology leaders from client teams. Ability to build engaging client presentations (Expertise on MS PowerPoint, MS Word, MS Excel, MS Project). Good understanding of disruptive digital technologies Strong executive presence and ability to interact with CxO level A proven track record of leading and managing both large and small, global and local teams Manage and build long-term client relationships Candidates authorized to work for any employer in the United States without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time PREFERRED QUALIFICATIONS An MBA with an advanced degree or equivalent experience Implementation experience in any Digital Supply Chain solutions - SAP IBP, Kinaxis Rapid Response, O9, E2Open, OMP etc. will be preferred. Implementation experience of Clinical Trial Supply Chain solutions with SAP ICSM Strong client-facing skills include presentations to senior leadership, advice and consult with clients. Ability to provide guidance to stakeholders in understanding business value of the initiative. Estimated annual total compensation range for this role for the New York, NY and Bridgewater, NJ area is $168,000 to $234,000. EEO/About Us : Benefits Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits: Medical/Dental/Vision/Life Insurance Long-term/Short-term Disability Health and Dependent Care Reimbursement Accounts Insurance (Accident, Critical Illness , Hospital Indemnity, Legal) 401(k) plan and contributions dependent on salary level Paid holidays plus Paid Time Off About Us Infosys Consulting is the global management and technology consulting practice of Infosys, a global leader in technology services and consulting. We combine the power of time-tested methodologies, people-driven innovation and disruptive technology to enable leaders of the world's top brands pursue a path of smart transformation. Together with our clients, internal and external partners, we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants: • Ability to design and implement end-to-end solutions at scale • A flat organization structure with direct access to our senior-most leaders • An entrepreneurial environment full of bright, highly motivated consultants • Opportunities for motivated consultants to impact local communities • The ability to design your career and drive your professional learning and development • A truly global culture EEO Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability

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 **********************

Physician Assistant Join our dynamic healthcare team as a Phyician Assistant dedicated to providing high-quality patient care in a fast-paced environment. As a Physician Assistant, you will play a crucial role in delivering comprehensive healthcare services to patients, collaborating with physicians and other healthcare professionals to ensure optimal patient outcomes. Responsibilities: - Conduct thorough patient assessments, including medical history reviews and physical examinations. - Develop and implement individualized care plans for patients, focusing on preventive care, health maintenance, and disease management. - Collaborate with interdisciplinary teams to coordinate patient care and ensure continuity of treatment. - Offer health coaching and education to patients on disease prevention, medication management, and lifestyle modifications. - Maintain accurate and detailed medical documentation in compliance with regulatory standards. - Participate in clinical research activities and contribute to the advancement of healthcare knowledge and practices. - Engage in utilization review processes to optimize healthcare resource allocation and patient outcomes. Qualifications: - Valid Physician Assisitant license in New York. - Certification as a Physican Assistant from an accredited certifying body. - Proficiency in medical documentation systems and electronic health records. - Strong clinical skills with a focus on evidence-based practice. - Excellent communication skills with the ability to interact effectively with patients, families, and colleagues. - Demonstrated commitment to ongoing professional development and continuing education. Join our team, where you can make a difference in the lives of patients every day. We offer competitive compensation, opportunities for growth, and a supportive work environment dedicated to excellence in patient care. Apply now and embark on a rewarding career as a Physician Assistant with us. Job Type: Full-time Pay: $140,000.00 - $160,000.00 per year Benefits: Dental insurance Employee discount Flexible schedule Health insurance Life insurance Paid time off Vision insurance License/Certification: PA-C (Required) Work Location: In person

Physician Assistant ? Clinical Research (Sub-Investigator) Brooklyn Clinical Research was founded to increase access to clinical trials for underrepresented populations. Clinical-trial enrollment should accurately represent the broader population. In meeting this objective, we help improve therapeutic efficacy and safety for all individuals. Position Overview: We are seeking a clinically adept, highly motivated Physician Assistant to join our growing research team as a Sub-Investigator. This is a hands-on clinical research role, working alongside our full-time Principal Investigator (MD) to conduct industry-sponsored clinical trials. The ideal candidate will thrive in a fast-paced, dynamic environment where flexibility, strong clinical decision-making, and attention to detail are essential. You will receive full training in clinical research and GCP, and you will play a key role in the daily conduct of clinical trials ? performing protocol-specific assessments, managing study visits, and ensuring participant safety and regulatory compliance. Key Responsibilities: Serve as a Sub-Investigator on assigned clinical trials under supervision of the Principal Investigator. Perform protocol-required medical evaluations, including detailed histories, physical exams, safety assessments, and medical oversight of study participants. Administer investigational products (e.g., vaccines, injectables) according to protocol. Perform and oversee clinical procedures including phlebotomy, vital signs, ECGs, and other protocol-specified tests. Assess and document adverse events and serious adverse events according to FDA and Sponsor guidelines. Maintain thorough, timely, and accurate source documentation and electronic data entry (EDC, eSource, CTMS). Collaborate closely with clinical coordinators, regulatory staff, sponsors, and CROs. Participate in monitoring visits, audits, and inspections. Maintain comprehensive knowledge of study protocols, informed consent documents, and regulatory requirements. Participate actively in team meetings, contributing to ongoing process improvement as our site grows. Qualifications: Graduate of an accredited Physician Assistant program (required). Active Physician Assistant license in New York State (required). Prior clinical research experience is a strong plus but not required ? training will be provided. Current BLS/CPR certification. Key Attributes for Success: Excited to work in a fast-paced clinical environment where protocols and patient needs can vary daily. Strong clinical acumen and independent judgment. Detail-oriented with excellent documentation skills. Highly organized with the ability to manage multiple protocols simultaneously. Excellent communication and teamwork skills. Commitment to patient safety, protocol adherence, and research integrity. Spanish fluency or medical Spanish is a plus but not required. Position Details: Full-time, salaried position, Monday?Friday. Occasional weekend work may be required during high-volume vaccine periods. Anticipated Start Date: Late July or Early August 2025 Salary Range: $140,000 to $170,000 depending on experience. Why Join Us: This is an excellent opportunity for a PA who is interested in advancing their career into clinical research while maintaining direct patient interaction. You will be a key member of a high-performing, mission-driven team with meaningful opportunities for professional growth as our research site expands. Job Type: Full-time Pay: $140,000.00 - $170,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance Medical Specialty: Addiction Medicine Emergency Medicine Endocrinology Hospital Medicine Infectious Disease Internal Medicine Interventional Cardiology Neurology Pain Medicine Primary Care Urgent Care Schedule: Monday to Friday No nights License/Certification: New York State Physician Assistant License? (Required) Ability to Commute: Brooklyn, NY 11226 (Required) Work Location: In person

The Clinical Coordinator is responsible for the complex, multi-disciplinary coordination of specialty patient population(s), developing, evaluating and revising care pathways based on assessments conducted through engagement with the patient, family and multiple departments and disciplines. The Clinical Coordinator interfaces directly with MSH Departments, Administrators, Nursing, Medical and Quality leadership, and clinical staff and coordinates care for a patient population regarding the clinical, educational and operational impact of all care delivery, and outcome measures. Responsible to: This position reports directly to discipline leadership with a professional line to MSH Nursing or related disciplines professional practice leadership. Responsible for: Developing and implementing a plan of care for a specialty patient population, and/or specialty specific standards of care organization wide. Responsibilities 1.Clinical Leadership Coordinates clinical care within a designated specialty, in conjunction with Nursing, Social Work, Care Management, and other related disciplines, Medical and Quality leadership, coordinates care across multiple departments and services within the context of the specialty program including the clinical plan of care, quality assessment and improvement processes. Establishes and implements short- and long-term goals, objectives, policies and operating procedures to ensure a high level of performance in nursing care delivery to the specialty patient population. Organizes and leads in the execution of day-to-day patient care coordination, as appropriate to program objectives and areas of clinical expertise. Provides consultation and education to members of the interdisciplinary team specific to the clinical specialty service, relative to the coordination of care for the specialty patient populations. Promotes an interdisciplinary approach to patient care delivery. Serves as a resource for patients and their families. Acts as a patient advocate utilizing the Patient Bill of Rights. Participates in promoting and maintaining a safe and therapeutic environment. 2. Development Serves as a resource to leadership and staff in the development and implementation of nursing standards consistent with the established model of care. Maintains leadership competency by participation in continuing education, professional organizations and other related activities. Supports academic affiliations for purposes of providing clinically enriching experiences for students of nursing and other related clinical disciplines. Works collaboratively with clinical leadership and supportive resources to ensure that patients have access to comprehensive interdisciplinary patient and family educational programs throughout their care trajectory. 3. Professional Practice Supports the mission, philosophy, goals and objectives of the Department of Nursing or Related Discipline and The Mount Sinai Hospital. Maintains clinical competencies, supports relationship centered care, the professional practice model, the care delivery model and is responsible and accountable for their own nursing practice. Advocates the highest standards of nursing or discipline related practice. Approaches patients, families and other members of the health care team in a professional, respectful manner. Serves as a clinical role model and resource to the nursing staff. Serves as a professional resource to other members of the health care team. Demonstrates professional involvement by: Attending and participating in workshops, seminars, and courses as presenter or author. Keeping abreast of current literature and trends in practice. Participating in related professional organizations. Considers ethical issues in professional nursing practice. Treats co-workers, patients and families with dignity and respect. Maintains attendance and punctuality record in accordance with departmental standards. Adheres to dress code in accordance with departmental policy. 4. Administrative Practice Collaborates with other members of the health care team in the development, implementation, and ongoing review of policies, procedures, and standards of care for designated patient populations. Demonstrates knowledge of hospital, departmental and care center standards, policies, procedures and guidelines as well as regulatory agency standards. Assures readiness for Joint Commission and other agency surveys and presents related programs during Joint Commission and other agency visits. Participates in the development and implementation of continuous quality improvement programs to support the professional practice model and care delivery systems Participates in quality management activities including identifying and communicating issues of performance improvement and risk in a timely manner, using chain of command. Leads and participates in committee activities Qualifications Education Requirements: Bachelor's degree in specific discipline (i.e., Bachelor of Science in Nursing) is required. Masters degree in health related field is preferred. Certification in specialty field is preferred Experience Requirements: 2 years' experience in specialty clinical field Licensing and Certification Requirements (if applicable): Current NYS nurse licensure BCLS certification Required Issuing Authority: AHA Collective bargaining unit: NYSNA-MSH About Us Strength through Unity and Inclusion The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual. At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history. About the Mount Sinai Health System: Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally. Equal Opportunity Employer The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.

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.

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

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

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)

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

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!

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

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.

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.

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.

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

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!

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