Clinical research coordinator jobs in Woodbridge, NJ

6 month contract w/ renewal 3 days onsite in Jersey City, NJ We are seeking a Clinical Scientist Data Reviewer that will support the scientific planning efforts and collaborate with Clinical Research, Pharmacovigilance and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate technical skills and scientific acumen as part of a cross-functional clinical development team. You will be a key contributor and supporter in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians, including protocol development, study implementation, data analysis and reporting of results. This role will be focused on the detailed and critical safety data review efforts from study start-up through final CSR. The Clinical Scientist Data Reviewer is a crucial role in analyzing and interpreting clinical trial data to ensure accuracy, integrity, and compliance with regulatory requirements. There is additional room for growth and leadership opportunities in this role. Responsible for supporting specific aspects of clinical/scientific execution of clinical protocol(s). This may include: Serving as a supportive clinical scientist data reviewer focused on safety, efficacy and critical data deliveries as part of the clinical trial team Supporting the clinical study team as part of the clinical sciences functional line which is closely aligned with the medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance (as well as other functional areas in this matrix environment) Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); partnering with Clinical Operations on critical and key study deliverables Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming Collaborating cross-functionally to review clinical data to ensure quality, completeness, and integrity of trial conduct Potential to provide tactical/scientific mentorship to other clinical scientists and move into Clinical Scientist lead role as well as focus on scientific growth and development Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate) Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs Qualifications 6+ years of experience with a Post Graduate Degree or 8+ years of experience with a Bachelor's degree in a relevant scientific discipline. Experience in clinical drug development experience, or a PhD, Pharm D, or RN degree is preferred. Experience within oncology preferred Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH) Ability to manage multiple competing priorities with good planning, time management and prioritization skills Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports Interact with key stakeholders across Clinical Development functional areas Role requires proactive approach, strategic thinking and leadership in driving toward clinical study goals Influence opinions and decisions of internal and external customers / vendors, across functional areas Problem solving, prioritization, conflict resolution and critical thinking skills Strong communication, technical writing, and presentation skills experience

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)

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.

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest. To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Clinical Research Associates II for coverage on the East Coast (Eastern time zone), Central Region (Central time zone), or West Region (Pacific or Mountain time zone). The incumbents may be required to travel to other locations across the USA to support monitoring activities as necessary. Key Accountabilities: Interact with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and relevant local regulations. Identify potential sites for participation in clinical trials. Perform protocol/site feasibility and Pre-Study Visits to recommend qualified sites. Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related questions as needed. Provide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed. Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan. Submit quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS). Complete monitoring visit reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance. Assist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requested. Review ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state. Establish regular lines of communication and administer ongoing protocol/study-related training to assigned sites. Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification). Assess the clinical research site's patient recruitment/retention success and offer suggestions for improvement. Ensure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies. Prepare sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations. Submit accurate and on-time expense reports. Assist with preparation of materials for Requests for Proposals and bid defenses. Assist the Clinical Operations team with additional related tasks as needed. Plan and carry out professional development. Complete timesheets as requested and on-time. Qualifications and Experience: Bachelor's degree in a Life Science or related field of study. Minimum of 4 years' of relevant and/or monitoring experience. Thorough knowledge of ICH-GCP guidelines and applicable regulations. Thorough comprehension of medical terminology. Excellent organization and communication skills (both verbal and written). Ability to travel a maximum of 70% of working hours to locations nationwide. Less travel hours may apply for projects with remote/virtual visits. Must maintain a valid driver's license and be able to drive to monitor sites. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at **************** We thank all interested applicants, however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #LI-Remote #LI-MG1

Global Clinical Trials (GCT) is a contract-research organization (CRO) offering support for clinical Phase I-IV studies and post-marketing activities to various organizations. Headquartered in Princeton, USA, GCT provides local and global support through multiple operational offices and a network of reliable partners. With over 100 clinical research professionals, GCT ensures individualized attention and a full range of services following industry guidelines. Role Description This is a full-time on-site role for a Clinical Research Associate at Global Clinical Trials located in Princeton, NJ. The Clinical Research Associate will be responsible for carrying out selection, initiation, monitoring and close-out visits at the participating clinical trial centers, as well as for remote coordination of the study. Qualifications * Experience in Clinical Trials, and Clinical Operations * Excellent computer skills * Strong attention to detail and organizational skills * Ability to work effectively in a team setting * Excellent communication and interpersonal skills * Bachelor's or Master's degree in a related field

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

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization • MS: 3 to 5 years of clinical development/clinical trial management • BS: 5 to 8 years with industrial or CRO clinical experience Experience in writing clinical portions of regulatory dossiers highly preferred • Knowledge of drug development (all clinical research process including protocol and case report form design, etc) • Knowledge of GCP/ICH guidelines and FDA regulations Additional Information $60/hr 12 MONTHS

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities The Analytical Scientist II is responsible for extracting and analyzing samples according to established procedures and SOPs. JOB RESPONSIBILITIES Perform all activities related to processing and analyzing biological samples. Participate in developing and validating bioanalytical methods. Documents the activities related to sample analysis and assist in verifying various documents. Assist in reviewing bioanalytical and method SOPs. Initiate analysis runs using the appropriate instruments and software. Follows-up on result analysis and assists in finding solutions to bioanalytical issues. Assist with the integration and revision of data using specialized computer applications. Assist in eliminating the chemical and biological waste generated by laboratory employees and helps clean laboratory equipment and instruments. Perform support tasks to meet the needs of laboratory users. Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management. QUALIFICATION Bachelors or College Degree in Science. Good understanding of bioanalytical processes used in the laboratory. Must demonstrate good computer skills especially in the utilization of Microsoft Word, Excel and analytical software. Knowledge of chromatography software. Experience in regulatory context. English level (Quebec specific); required bilingualism includes understanding simple messages and following basic instructions. Relative alternate certification may be considered acceptable. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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!

Clinical Research Scientist Early Development We are seeking a motivated Clinical Research Scientist to join our Clinical Development team and support the execution of innovative clinical studies. This individual will work closely with senior scientists, physicians, and cross-functional partners to contribute scientific expertise, data insights, and clinical input across multiple programs. Key Responsibilities Assist in the design and development of study protocols and protocol amendments. Contribute to the preparation of clinical and regulatory documents, including sections of INDs, study reports, investigator brochures, and updates for health authorities. Provide scientific input into study tools such as case report forms, statistical analysis plans, and data output specifications. Participate in the review and interpretation of clinical safety and efficacy data;support data monitoring activities throughout study conduct. Collaborate with internal study teams and external partners (CROs, vendors, investigators) to ensure high-quality study execution. Present study progress and scientific updates to project leadership and cross-functional committees. Support preparation of data for abstracts, posters, presentations, and manuscripts. Stay informed on evolving therapeutic landscapes, competitive intelligence, and standards of care relevant to assigned programs. Qualifications Advanced degree in a life science discipline preferred (Pharm.D., Ph.D., or equivalent). 1 3 years of experience in clinical research, with at least 1 year in drug development or industry setting. Background in oncology or hematology is a plus. Strong analytical skills and attention to detail, with ability to interpret and communicate complex data. Excellent organizational, written, and verbal communication skills. Ability to work effectively in a fast-paced, collaborative environment and manage multiple priorities. Willingness to travel occasionally (up to ~20%). Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws. By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

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

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. As the Jr. Clinical Research Coordinator, you will be responsible for coordinating and facilitating the daily activities that play a critical role of the clinical studies according to the protocol, Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal and applicable regulations Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Sets up and conducts studies in compliance with the protocol, SOPs, applicable regulations, and GCPs. * Prepares, completes, organizes, and maintains all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study-specific documents. * Performs station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information. * Prepares for and conducts pre-study meetings; assures that staff working on their managed studies understand and are performing duties according to the protocol, SOPs, and GCPs. * Reviews and provides feedback on draft protocols, recruiting materials, and draft clinical study reports. * Coordinates scheduling subjects for visits and orders checks for subject compensation. * Responds to queries from Quality Assurance and Statistics Departments. * Prepares and is accountable for all Test Material for managed studies. * Adheres to the study budget. * Provides excellent customer service to clients and panelists and maintains positive interaction with peers and supervisors. * Completes other duties or tasks assigned by the Clinic Manager and/or Supervisor. * Adheres to internal standards, policies, and procedures. * Performs other duties as assigned. Qualifications * Bachelor's in science, or other equivalent degrees - Required * Candidate must be bilingual (English and Spanish) - Required * 0-1 years of experience - Preferred Additional Information SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time. If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

Site 4 days per week at our Princeton NJ or Miami FL Summit Summit Therapeutics Inc is a biopharmaceutical oncology company with a mission focused on improving quality of life increasing potential duration of life and resolving serious unmet medical needs At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology Summit has multiple global Phase 3 clinical studies including Non small Cell Lung Cancer NSCLC HARMONi Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who were previously treated with a 3rd generation EGFR TKIHARMONi 3 Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLCHARMONi 7 Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLCColorectal Cancer CRC HARMONi GI3 Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration NMPA Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland Overview of Role The Clinical Research AssociateCRAisresponsible for Supporting all aspects of Clinical Trial Management for complex global studies from study planning and start up through study close out This role will collaborate withfunctional team members CROsand vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or DirectorThe CRAis responsible foradherenceto all performance metrics and quality of deliverables in the clinical trial Role and Responsibilities Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained remain current with project requirements and have a thorough understanding of study milestones and deliverables Reviewapprovetrack vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high quality data Creationand developmentof study trackers Develop and provide clear complete documentation of study specific meetings actionitemsand action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including but not limited to consent documents site welcome packets study binders etc Responsible for reviewing assigned study related plans processes agreements and guidelines Following and implementing assigned study related plans processes agreements and guidelines Responsible for requesting and logging CRO and vendor RFIs RFPs contractswork orders and specifications to enable studyobjectivesto be met Reviews and approves essential document packages to enabletimelysite activations Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol and proactively addresses conduct issues andenrollmentproblems as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study Perform periodic QC of the TMF Oversee the execution of clinical trial activitiesin accordance with Good Clinical Practices Ensures compliance of clinical trials with national regulatory requirements and co monitoring the assigned clinical trial following company SOPs Ensures the study is inspection ready contemporaneously Responsible for supporting functional activities of Clinical Trial Associatesallocatedto the project through leadership and training as indicated and appropriate All other duties as assigned Experience Education and Specialized Knowledge and Skills Bachelors degree or equivalent in life science nursing pharmacy medical laboratory technology or other healthmedical related area preferred A minimum of 3years of clinical research experience in conducting clinical trials Prior phase II or III experiencerequired A solid understanding of the recruitment methods drug development process ICH guidelines GCP and specifically each step within the clinical trial process Experience with clinical studies oncology and or rare diseases a plus Sophisticated understanding and highlyskilfulutilizationof Microsoft Apps such as Outlook Word Excel and Teams Ability to travel internationally to visit clinical sites and for study meetings Amount will vary upon project needs up to 20 Tenacity to work in a fast paced team environment Enjoys building relationships with KOLs and site personnel Willing to travel toestablishrelationships Ability to successfully engage and work collaboratively with global team memberscolleagues Ability to support building and delivery of patientenrolmentstrategies Excellent interpersonal anddecision makingskills Demonstrates innovationpossessesdriveenergyand enthusiasm to deliver the programobjectives Ability to review and assess clinical data Possesses excellent planning time management & coordination skills Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements interactions with external parties timelines and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills The pay range for this role is 97000 114000 annually Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location This may be different in other locations due to differences in the cost of labor The total compensation package for this position may also include bonus stock benefits andor other applicable variable compensation Summit does not accept referrals from employment businesses andor employment agencies in respect of the vacancies posted on this site All employment businessesagencies are required to contact Summits Talent Acquisition team atrecruitingsmmttxcomto obtain prior written authorization before referring any candidates to Summit

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization • MS: 3 to 5 years of clinical development/clinical trial management • BS: 5 to 8 years with industrial or CRO clinical experience Experience in writing clinical portions of regulatory dossiers highly preferred • Knowledge of drug development (all clinical research process including protocol and case report form design, etc) • Knowledge of GCP/ICH guidelines and FDA regulations Additional Information $60/hr 12 MONTHS

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

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

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