Clinical research associate jobs in Wayne, NJ - 294 jobs

Aidoc is recruiting a Director of Clinical Research in the United States. Join our team! Aidoc helps health systems deliver smarter and faster care when it matters most. Its mission is to transform patient outcomes through 'always on' clinical AI, eliminating preventable care gaps that lead to loss of lives and disabilities. Through our proprietary ai OS platform, Aidoc seamlessly integrates real-time intelligence into provider workflows, helping physicians make faster clinical decisions for over 45 million patients a year. With the most FDA-cleared AI solutions in its category and deployments across 150+ health systems globally, Aidoc elevates the physician and patient experience.Backed by General Catalyst, Square Peg, NVentures (NVIDIA's venture arm), and four major U.S. health systems, Aidoc has raised $370 million to date, including a recent $150 million round to accelerate development of CARE, its clinical-grade foundation model. About this role We're seeking an experienced Director of Clinical Research to lead strategic projects and clinical studies that enhance the clinical credibility of AI in radiology. This role will oversee a growing team, ensuring the development of high-quality clinical evidence that validates the value of our solutions. You will work closely with cross-functional partners in product, data, sales, and marketing, while cultivating strong research relationships with customers and key opinion leaders. Responsibilities Lead, mentor, and develop the Clinical Research team, with a focus on performance management, capability building, and building a culture of accountability and collaboration. Partner cross-functionally with Regulatory, Product, and Marketing teams to ensure research priorities support business goals. Translate company strategic objectives into a clear clinical research roadmap that supports product validation and market adoption. Oversee prioritization, initiation, and completion of clinical research studies, ensuring they advance organizational goals rather than just individual project milestones. Establish and optimize end-to-end research processes (study planning, execution, reporting, and dissemination) to drive efficiency, quality, and scalability across programs. Implement tools, systems, and metrics that enable transparency, accountability, and proactive risk management within the research portfolio. Drive adoption of standardized workflows and best practices across studies to ensure consistency and regulatory compliance. Requirements Bachelor's or Master's degree in Clinical Sciences, Health/Life Sciences, Health Economics, or related field (PhD preferred). Minimum 5 years of experience managing teams in a clinical research or scientific environment. Strong track record of delivering clinical studies and publications in peer-reviewed journals. Deep understanding of clinical research design, statistical interpretation, and data analysis. Proven ability to lead complex, cross-functional projects in a fast-paced environment. Exceptional communication and writing skills, with experience presenting at scientific conferences. Medical or scientific writing expertise. Working at Aidoc We're a dynamic, collaborative and fast growing team of more than 400 global employees, committed to improving the world of healthcare. We're looking for mission-driven people excited to do transformative work. We have offices in Tel Aviv, Barcelona and New York City, but Aidoc is a remote-first workplace. We're able to hire US-based employees across the continental United States, although certain roles may be region-specific. What we offer: A range of medical, dental and vision benefits Stock options for all full-time employees 20 days of paid vacation, plus sick days and holidays A 401(k) plan, life insurance, plus long and short term disability The opportunity to directly improve medical care and impact patient outcomes Aidoc is deeply committed to creating an inclusive and diverse workplace, and to the principle of equal opportunity for all individuals. We prohibit harassment of any type as well as discrimination based on race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, or any other status protected by law.

We are seeking a dedicated Clinical Trial Specialist to join our team, focusing on protocol activation and study accrual. This role involves collaborating with various departments to initiate and activate new clinical trial protocols, ensuring compliance with regulatory requirements, and providing high-quality patient care. The successful candidate will facilitate communication between patients and research teams, manage protocol-specific orders, and ensure adherence to study guidelines. Responsibilities + Collaborate with the Protocol Activation office to initiate and activate new clinical trial protocols, utilizing study-start up task lists. + Prepare and review study tools, including study binders, medication diaries, eligibility checklists, and flow sheets. + Verify Scientific Review Board (SRB), Institutional Review Board (IRB), data collection plans, and finance/contract approvals prior to study activation. + Conduct protocol-related nursing education to facilitate safe, effective care of enrolled patients. + Translate finalized protocol treatment plans, study calendars, and clinical trials billing grids into sample orders. + Coordinate with the clinical research team for timely prescreening of potential subjects and active cancer patients for available clinical trials. + Review patient charts and medical history to confirm protocol eligibility and obtain source documents as needed. + Ensure informed consent processes are followed, and consent is obtained, signed, and documented in medical records. + Provide back-up support for registering consented research patients with study sponsors and input data into the clinical trials database. + Serve as a resource for Clinical Trial Billing Information related to assigned studies. + Act as a link between patients and research team members, addressing and communicating challenges in protocol procedures. + Ensure accurate execution of protocol-specific orders, scheduling, and completion of tests and appointments. + Coordinate protocol-specified procedures and treatments for study patients across disciplines and sites of care. + Manage patient reimbursement while on clinical trials using study-specific methods. + Deliver compassionate oncology nursing care and coordinate with clinical teams as per protocol requirements. + Provide nursing assessments and documentation for protocol-specified visits, ensuring reconciliation of concomitant medications. + Drive collaboration with medical system staff to ensure timely service delivery to patients. + Grade adverse events using protocol-referenced criteria and document toxicities accurately. + Complete Serious/Unexpected Adverse Event forms and ensure accurate completion of follow-up reports. + Assist with monitoring visits, audits, and provide timely responses to sponsor queries. + Maintain research records for screened and enrolled patients, ensuring compliance with regulations and standards. + Participate in training programs, workshops, and disease-specific meetings to stay up-to-date on departmental objectives. + Provide training and orientation to faculty and staff as needed. Essential Skills + Three years of relevant clinical research experience. + Bachelor's Degree required. + Solid knowledge of clinical research processes and oncology. + Comfortable communicating with patients. + Experience in pediatric oncology is preferred. Work Environment Our vision is to be a leader in scientific discovery, patient care, and education in cancer research. We conduct innovative research and cutting-edge patient-centered care to improve cancer outcomes. The clinical operations team consists of 40 FTEs across disease-specific groups such as breast, lung, phase 1, and GI. We operate in Newark and 12 other sites, with a goal of enrolling 5,000 subjects per year in over 300 active trials across all phases, including both adult and pediatric studies. Job Type & Location This is a Contract to Hire position based out of Newark, NJ. Pay and Benefits The pay range for this position is $33.00 - $38.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Newark,NJ. Application Deadline This position is anticipated to close on Jan 27, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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 ? 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

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

About the Job Job Title: Certified Clinical Research Coordinator (CCRC) Part-Time | One Day per Week (On-Site) 222 East 31st street, second floor, New. York, NY 10016 We are seeking a Certified Clinical Research Coordinator (CCRC) to join our growing clinical research site on a part-time basis (one day per week). This role is ideal for an experienced coordinator who values high-quality research, operational excellence, and schedule flexibility. The CCRC will play a critical role in ensuring the ethical, regulatory, and operational integrity of clinical trials while supporting investigators, participants, and sponsors in a highly organized and patient-centered environment. Key Responsibilities: Coordinate and manage assigned clinical trials in compliance with GCP, ICH, FDA regulations, and IRB requirements. Serve as the primary point of contact for study participants, investigators, sponsors, and CROs on assigned study days. Conduct study visits, including participant screening, informed consent, visit coordination, and protocol-specified procedures. Ensure accurate, timely, and complete documentation in source documents, EDC systems, and regulatory binders. Support monitoring visits, audits, and inspections, ensuring readiness and responsiveness. Maintain study supplies, investigational product accountability, and specimen handling per protocol. Collaborate closely with the Principal Investigator and research leadership to support study success. Qualifications: Certified Clinical Research Coordinator (CCRC) required. Minimum 2+ years of hands-on clinical research coordination experience. Strong working knowledge of GCP, ICH, FDA regulations, and IRB processes. Experience working directly with sponsors, CROs, and monitors. Excellent organizational skills with high attention to detail. Professional, patient-centered communication style. Ability to work independently and efficiently in a focused, one-day-per-week role. Preferred Experience: Experience in industry-sponsored clinical trials. Familiarity with EDC platforms (e.g., Medidata, REDCap, Veeva, or similar). Experience across multiple therapeutic areas (not required). Schedule & Commitment: One consistent day per week (on-site). Ideal for professionals seeking: Supplemental income. Portfolio or semi-retired work. Balance alongside another research or clinical role. What We Offer: Competitive hourly compensation commensurate with experience. A highly organized, collaborative, and respectful research environment. The opportunity to contribute meaningfully to clinical research without a full-time commitment. Stable, predictable schedule with minimal administrative burden. How to Apply Please submit your CV and a brief cover note highlighting your clinical research experience and availability. AboutBethany Medical Clinic About Bethany Medical Clinic of New York:At Bethany Medical Clinic, we value our patients' time and busy schedules. That is why we offer early morning and after work hour appointments at our conveniently located Murray Hill office in New York City. Our goal is to keep waiting time to a minimum and maximize our high level of expertise in an efficient manner during your appointment. You can expect a personalized, non-corporate approach and compassionate care. We embrace the contemporary philosophy that primary care should be predictive, rather than reactive. We not only listen to our patients, but we help them shape their own healthcare journey. Visit our website at *************** for more information!

Weekend Clinic Coordinator position requires a highly motivated, knowledgeable and dynamic individual who is responsible to assist in the day-to-day organization of the Weekend Clinic Programming. Responsibilities • With support from senior staff, develop and schedule activities that fulfill the program's objectives and that address the needs and interests of students and families • Assist in recruiting children and families to participate in the program • Assist in hiring, supervising and support a staff • Assist in the interviewing, managing, training, and coaching of program staff and volunteers • Assist in creating a strong sense of community which values respect, acceptance, and high expectations • Review lesson plans weekly; support the development of curriculum maps and activity plans • Participate in community outreach programming Requirements • Strong commitment to Breakaway Hoops' mission to educate for social responsibility and to foster students' social and emotional learning • 2 year degree required; BA a plus • 3+ years experience leading highly effective youth programming • Excellent social and emotional skills

Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications. At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources. Job Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, Client, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications BS/MS Additional Information For more information, Please contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

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!

Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits. I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization. Job Description Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/ CTD/ MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry Additional Information All your information will be kept confidential according to EEO guidelines.

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

Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Trial Associates (CTA). This role will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents, assisting with study start-up, conduct and close-out of study activities. This individual will have accountability for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF). Key Responsibilities * Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation. * Set up and maintain study-specific paper and electronic TMFs. * Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices. * Track and report CRO's ability to maintain TMF health metrics on an ongoing basis. * Process essential documents and ensure they are correctly filed in the appropriate TMF. * Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed. * Participate in GxP audits and related clinical operations compliance and inspection readiness activities. * Prepare and track study documents (e.g., contracts, budgets, IRB documentation). * Assist with information gathering, literature searches, and creation of presentations, as needed. * Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.) * Administer user access and change control within Anavex's electronic systems. * Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems. * Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards. * Assist with vendor management and associated logistics, as assigned. * Contribute to the creation of presentations, as needed for project, departmental, sponsor, and/or business development presentations. * Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies. * Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel) * Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual. * Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management. * Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF. * Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information. * Assist in creating and implementing departmental SOPs and procedures. The position will be filled at a level commensurate with experience. Requirements * BS/BA in Life Sciences or equivalent * 3+ years of experience in similar positions in Biotech, Pharmaceutical, or clinical research organization environment * Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC/ QR, and query management. * Familiar with the DIA reference model * Knowledge of ICH/GCP and applicable regulations * Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence the decision-making of managers, and working partners (local and global) * Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining a high attention to detail and responding to rapidly changing priorities and aggressive deadlines * Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox * Strong critical thinking, organizational and time-management skills * Ability and willingness to travel (up to 10% of the time)

Clinical Research Coordinator -Oncology On-site 4 days per week Clinical Research Coordinator This role is critical in supporting Oncology clinical trials from initiation through completion, ensuring compliance with regulatory standards and delivering high-quality data. Helping with managing research protocols involving tissue specimens. review research protocols for feasibility and ensure alignment with institutional capabilities, specimen availability and regulatory requirements. Key Responsibilities + Collaborate with principal investigators, pathologists, and lab personnel to identify and procure appropriate specimens for translational and retrospective studies. Coordinate initiation and activation of new clinical trial protocols + Support workflow improvements by identifying operational inefficiencies and developing solutions to streamline specimen processing, tracking, and data capture. + Assist with grading adverse events using NCI toxicity criteria; complete SAE forms per sponsor and regulatory requirements + Generate regular reports for tumor study groups and Principal Investigators using OnCore + Serve as liaison with study sponsors; schedule monitoring visits and respond to queries promptly + Perform blood processing as required for clinical trial protocols Qualifications + Bachelor's degree required + 2+ years of clinical research experience (patient recruitment, data collection, data entry) + Specimen Processing experience + Oncology Experience + Experience recruiting, screening, and consenting patients for clinical trials + Proficiency in multiple EDC systems (Medidata and Inform highly preferred) + Familiarity with OnCore and Microsoft Office Suite + Blood processing experience Job Type & Location This is a Contract to Hire position based out of bronx, NY. Pay and Benefits The pay range for this position is $30.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in bronx,NY. Application Deadline This position is anticipated to close on Feb 2, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications. At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources. Job Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, Client, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications BS/MS Additional Information For more information, Please contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

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!

Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits. I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization. Job Description Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/ CTD/ MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry Additional Information All your information will be kept confidential according to EEO guidelines.

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