Clinical Research Scientist Jobs

Job Title: Clinical Research Scientist Company: MedFocus Location: Florham Park, NJ Description: CLINICAL RESEARCH SCIENTISTCOMPANY INFO:MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.Our client is a company that wants to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life and is seeking to add a Clinical Research Scientist to their team in Florham Park, New Jersey.RESPONSIBILITIES:• Under supervision responsible for the preparation, management and implementation of clinical trials and registries (safety, data consistency, trial timelines, budget, resources, eligibility, enrollment, vendor selection and vendor management). • Will contribute to the preparation of clinical program documents (e.g., study proposals, study protocols, clinical study reports (CSR) and submissions, etc.) as applicable. • May serve as Clinical Trial Leader (CTL) under the direction of a Manager for assigned projects • Under general direction will interact with International Clinical Research Operations (ICRO) or external Contract Research Organizations (CROs) regarding day-to-day activities of clinical trials. • Will participate in the preparation of materials for Investigator Meetings and internal update meetings. Will present, as necessary. • Responsible for managing assigned third-party Investigator Initiated Trials (ITT) including tracking study progress by reviewing internal trial tracking databases (e.g., ClinAdmin, Salisbury, etc.) and follow–up with CPO colleagues, as necessary. • Will assume responsibility for management of global ITT budgets and forecasting of drug need for assigned ITT’s when departmental system is developed. May participate in development of such system. • Will represent GMA team at assigned regularly scheduled meetings (e.g., International Clinical Team (ICT), Safety Management Team (SMT), Medical Review Committee (MRC), etc.) • Will become familiar with the CUP and it’s function and purpose. May be asked to learn the CUP process and assist with daily operational needs. May be called upon to serve as a back-up in the event of staffing issues or emergencies and assisting team with coverage during holidays. • Responsible for data review and data compilation for data mining projects, as assigned. May liaise with outsourced vendors depending on data mining project. In such situations will collaborate with scientific communications director in support of publications. QUALIFICATIONS:• Minimum 2 - 5 years experience in drug development for this Senior CRS / CRS role. • Industry experience in a variety of areas with increasing levels of responsibility • Knowledge of clinical trial design; basic statistics and pharmacokinetics • Solid medical/scientific writing skills; ability to effectively communicate across the business organization, both upward and downward. • Knowledge of Oncology therapeutic area strongly preferred. Experience with Leukemia Studies beneficial. • Knowledge of good clinical practices (GCP/ICH) and regulatory requirements. • Basic working knowledge of clinical database systems. • Strong experience and knowledge of basic Microsoft Office computer programs (i.e., word, excel, and project) required. Basic knowledge and experience with Microsoft Access a plus. • Ability to collaborate and work effectively in teams. • Fluency in English (oral and written) required. Conversation ability in other languages a plus. • Demonstrated competencies in line with established profile. • Four-year university degree (BA/BS). Degree in Life Sciences, Nursing, or equivalent, preferred. MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.s to determine study priorities and objectives, an

Job Title: Sr. Clinical Research Scientist, Early Clinical Dev t, Immunology/Vascular:Top Mid-sized and Growing Company: Cornerstone Search Group, LLC Location: Montvale, NJ Description: Sr. Clinical Research Scientist, Early Clinical Dev’t, Immunology/Vascular: Top Mid-sized and Growing Pharma, New Jersey Summary: A top pharmaceutical company in Northern New Jersey has an opening for an experienced clinical development professional to come in and lead/manage their immunology and vascular studies in early clinical development. In this role you will be responsible for scientific/medical aspects within high-profile group and a growing pipeline. Our client has always been known as a divese company offering both a challenging working environment coupled with employee-friendly benefits/company policies. Location: Montvale, NJ area Attractive Features About This Position and Company: Use your medical/scientific education/experience to your advantage. This position is not in operations, rather you will focus more on the scientific aspects of early clinical development. This is a very successful company with a bright future as it has multiple approved drugs in multiple therapeutic areas and a rich multi-therapeutic pipeline. A smaller group within the company so there is a lot of opportunity for growth and internal advancement Considered to have one of the best benefit programs in the New Jersey pharma industry. Financially strong and profitable company with sales in the multi-billions. Very attractive environment and collegial atmosphere. Responsibilities: Manage and assist in clinical development plan review and execution. Implement Clinical Study Design. Play a key role in the IND/NDA process. Scientifically responsible to plan, manage, and implement clinical trials. Prepare and write clinical trial Protocols and patient narratives (ISS, ISE, Investigator Brochure, etc.). Making recommendations for the supervision of monitoring, clinical trial conduct (enrollment, GCP practices, etc.). Assisting in database evaluability assessments. Requirements: 3+ years of experience in clinical research in the pharmaceutical industry Ideally an MD or PhD degree. PharmD degree (or in some cases a Masters degree) might also be considered. A thorough understanding of clinical research methodology including study design and conduct, protocol writing and CRF preparation is required as is a knowledge of GCP and local regulatory requirements. Working knowledge of the IND/NDA process acquired through direct industry experience is required. Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area. Contact: Brian C. Skurka Senior Recruiter Cornerstone Search Group, LLC 6 Campus Dive Parsippany, NJ 07054 P Register to View Register to View Web/URL: www.cornerstonesg.com About Cornerstone Search Group, LLC Cornerstone Search Group is a specialized Pharmaceutical | Biotechnology Executive Search & Recruitment firm located in heart of New Jersey's Pharmaceutical corridor. Cornerstone Search Group helps its Pharmaceutical | Biotechnology clients identify, attract and hire accomplished professionals from the experienced Staff Levels through the Senior Leadership ranks who are involved with the discovery, development and commercialization of drugs/therapeutic treatments for the US and international markets. Cornerstone Search Group's team of highly experienced Pharmaceutical | Biotechnology Specialty Consultants/Recruiters are adept at using their industry knowledge and contacts to generate desired results for their clients and candidates. Building better companies. Building better careers.® Other Opportunities Cornerstone Search Group is currently working on Executive Search & Recruitment assignments in several of the following business areas: Discovery, Clinical Research & Development, Medical Affairs and Commercial/Marketing, and in several of the following functional areas: Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Data Management, Health Economics & Outcomes Research, Market Research, Medical Affairs, Medical Directors, Clinical Scientists, Medical/Drug Information, Medical/Scientific Communications, Medical Writing, Pricing & Reimbursement, Product/Brand Management, QA/QC, Pharmacovigilance & Drug Safety, Regulatory Affairs, Scientists, Sourcing and Pathologist. Please visit our company’s web site for a comprehensive listing of available positions/opportunities at www.cornerstonesg.com. Keywords: Clinical Development, Clinical Scientist, Clinical Research Scientist

Job Title: Research Scientist Clinical - PK/PD Company: Discovery Solutions, Inc. Location: Branchburg, NJ Description: Research Scientist -- Clinical PK/PDDMS 210437COMPANY:Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.LOCATION:Branchburg, NJDESCRIPTION:This position is responsible for the performance and reporting of all aspects of pharmacologic analysis of clinical trial samples including pharmacokinetic, pharmacodynamic and immunogenicity analysis. The candidate must be able to work within a team, to design, validate and implement bioanalytical methods used to identify the appropriate dose and dosing regimen of therapeutic products. This position will seek to identify/confirm potential mechanism(s) of action of our therapeutic products in the clinical setting.Design, validate and implement bioanalytical methods used to identify the appropriate dose and dosing regimen of therapeutic products.Assist in establishing appropriate pharmacodynamic analytical methodsPrepare and perform bioanalytical analyses on clinical trial samples and summarize data in technical memos and/or study reports.Author standard operating procedures, validation protocols and reports to reflect laboratory practiceMaintain all necessary laboratory documentation that pertain to the assay of samplesPerform routine laboratory maintenance activitiesExtract data from clinical databasesPerform Quality Control audit of data, forms and databasesEXPERIENCE:5+ years experience in a clinical research laboratory, biopharmaceutical industry or basic research laboratory preferred.Excellent verbal and written skills. Ability to communicate across functional areas (clinical, regulatory and manufacturing).Ability to work within a team environment and willingness to contribute to the overall goals of the Clinical Pharmacology group.Familiarity with laboratory information management systems (Watson), Laboratory Automation (Biomek) and data analysis software (Winonlin, JMP)Ability to understand and follow Standard Operating ProceduresAbility to work with little supervision as well as direct support lab personnel.Knowledge of biosafety procedures for handling human blood and its components.Practical knowledge of immunology based assays including but not limited to ELISA, ECLA, BiaCore analysis. Practical knowledge of immunogenicity assay.EDUCATION:B.S. in a biological science or pharmacologic discipline.Please refer to job code DMS 210437 when responding to this ad.

Job Title: Clinical Research Scientist/ Senior Clinical Research Scientist Company: MRINetwork Location: Princeton, NJ Description: Clinical Research Scientist/ Senior Clinical Research ScientistResponsible for all operational aspects of 1 or more OGD clinical trial(s) under the leadership of Clinical Trial Head (CTH). Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned.Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards.Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing.Prepare training materials and presentations related to the planning and conduct of the trial.Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations ( CROs) and ensure adherence to scope of work within timelines and budget.Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and company local medical organizations.Accountable for accuracy of trial information in all trial databases and tracking systems.Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD.Participate in the organization and logistics of various oversight and Advisory boards; attend meetings.Point of contact for managing/answering questions related to trial procedures and patients’ eligibility.Write CTT meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team meetings.May participate in International Clinical Team meetings.Contribute to program level activities (e.g., tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions).Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned.Contribute to talent and career development of OGD staff through active participation in on-boarding, training and mentoring activities. May serve as faculty member for OGD training programs.Minimum requirements:Master's degree in SCIENCE (MS) Also 3+ years experience in Phase 2-3 Global clinical trials from the pharma, biotech or CRO industry. Oncology Trial experience is strongly preferred.Plus:Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities. Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines. Proven networking skills and ability to train colleagues. Proven ability to work both independently or in a team setting, including a matrix environment Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process. Knowledge of principles for trial budgeting. Basic knowledge of oncology and/or hematology preferable.Required years of experience - Three to Five YearsCompensation: $95k - $105kLocation: New JerseyFor confidential consideration, please forward your resume to Register to View Visit www.kleinhersh.com to view additional job opportunities available through our company.

Job Title: Clinical Research Scientist/Project Manager-Medical Devices for Princeton Pharma Co. Company: Cornerstone Search Group, LLC Location: Princeton, NJ Description: Clinical Research Scientist/Project Manager-Medical Devices for Princeton Pharma Co. Summary: Highly attractive opportunity to use your clinical research, clinical operations and clinical project management experience to lead/manage medical device clinical studies for this Princeton, NJ area Pharmaceutical Company with multiple FDA approved drugs marketed in the USA. Confidentiality: All submissions & inquiries are held in strict confidence.     Company Description: A very successful, profitable and expanding global pharmaceutical company located in the Princeton, NJ area.  Location: Princeton, New Jersey areaCompensation: Compensation will vary depending upon the depth and quality of your relevant  clinical medical device and drug development experience.,  Attractive features about this position and company: Highly visible new position that will work closely with Sr. ManagementImpact position where you will manage this Pharma Co’s medical device clinical studies.Highly visible position offering a chance to make a real impact       Take on responsibility for clinical trials that you can work on from A to Z, i.e. from Phase I through Phase III/IV and NDA/PMA submission(s)Join a team of very talented and friendly professionalsReceive a great benefits package Responsibilities: In a nutshell, plan, you will be involved with performing all critical Clinical Research activities (i.e. development/design of protocol, clinical development plan, CRFs, ICFs—reviewing/evaluating clinical data/evidence, contributing to the writing of CSRs, NDA submissions…) for multiple clinical studies (Phase I through Phase III) leading up to the filing/submission of NDAs.  You will also work closely with the Clinical Operations Team to help plan/guide/evaluate their activities/progress too.     Requirements: Education: BS/BA and an advanced degree is highly preferred (not required) Clinical study experience to include experience working on new Medical Devices and new drugs/compounds in clinical development, i.e. experience with pilot and pivotal medical device studies and Phase I-III clinical drug development studies.  Clinical Research Experience: 5 or more years of progressive Clinical Research experience gained working for a pharmaceutical/biotechnology/medical device/CRO company, i.e. input to the design of protocols, clinical plans, CRFs, ICFs, …, and reviewing and evaluating clinical data/evidence, and being the point-person for questions raised about the protocol by PIs, investigational site personnel, CROs…and contributing to the writing of Clinical Study Reports (CSRs), NDA submissions…Clinical Operations Experience: 5 or more years of Clinical Operations experience, i.e. experience with the day-to-day management of running clinical trials: site initiation, site monitoring, site issue resolution, directing and managing CROs …Project Coordination/Management Experience: Experience coordinating with other functional areas involved with planning & executing clinical studies: Regulatory, Medical Writing, Drug Safety, Biostatistics, Clinical Data, CROs…   Contact:Cliff Miras (email contact works best for initial communications) Co-founder & Managing PartnerCornerstone Search Group, LLC6 Campus DriveParsippany, NJ 07054P Register to View ext 711F Register to View Email Cliff Miras: Register to View Web/URL: www.cornerstonesg.comLinkedin profile: www.linkedin.com/in/cliffmirasLinkedin Group: Cornerstone Search Group  About Cornerstone Search GroupCornerstone Search Group is a specialized Pharmaceutical | Biotechnology Executive Search & Recruitment firm located in heart of New Jersey's Pharmaceutical corridor. Cornerstone Search Group helps its Pharmaceutical | Biotechnology clients identify, attract and hire accomplished professionals from the experienced Staff Levels through the Senior Leadership ranks who are involved with the discovery, development and commercialization of drugs/therapeutic treatments for the US and international markets. Cornerstone Search Group's team of highly experienced Pharmaceutical | Biotechnology Specialty Consultants/Recruiters are adept at using their industry knowledge and contacts to generate desired results for their clients and candidates. KeywordsIDE, medical device, PMA, protocol, Clinical, Trial, Study, Project,  Investigational, Medical,  IND, NDA, subject, patient, Clinical Study Report, CSR, Clinical Development Plan, CDP, Investigational Brochure, IB, monitoring, monitoring plan, Clinician, Medical Monitor, Adverse Event, AE, Serious Adverse Event, SAE, Clinical Data Plan, CDP, Clinical Research Associate, Clinical Research Assistant, CRA, Senior CRA, Sr. CRA, Lead CRA, Regional CRA, Clinical Study Manager, Clinical Trial Manager, Clinical Project Manager, CSM, CTM, CPM, Project Manager, Project Management