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Clinical Research Coordinator Jobs in Raritan, NJ

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Clinical Research Coordinator
Clinical Trial Manager
Clinical Research Associate
Clinical Study Manager
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Senior Clinical Research Coordinator
Clinical Researcher
Senior Clinical Research Scientist
Clinical Scientist
Clinical Associate
Clinical Research Manager
Clinical Research Scientist
Study Coordinator
Clinical Research Specialist
Research Project Coordinator
  • Senior Clinical Trial Manager

    Barrington James

    Clinical Research Coordinator Job 15 miles from Raritan

    Join a Leading Pharmaceutical Company Driving Innovation in Hem-Onc Therapies Senior Clinical Trial/Operations Manager (CTM) Contract: 6 Months Renewable (40 hours per week) - Projects will be ongoing for years to come. Location: Hybrid Are you an experienced Clinical Trial/Operations Manager ready to make an impact in advancing oncology therapies? We are looking for a driven professional to lead and manage Hematology/Oncology clinical studies, ensuring exceptional performance and adherence to industry standards. Key Responsibilities Audit & Inspection Preparation: Support Clinical Operations in achieving inspection and audit readiness. Vendor Oversight & Third Party Management: Manage and oversee CROs and other external vendors to ensure quality deliverables and adherence to study timelines and budgets. Evaluate vendor performance and address any gaps or concerns proactively. Running Trials: Lead the day-to-day operations of clinical trials from start-up to close-out, ensuring seamless execution across all phases. Monitor study progress, identify challenges, and implement solutions to meet milestones. Work with Cross-Functional Teams: Collaborate with clinical, regulatory, medical, and biostatistics teams to align operational strategies with overarching project goals. Provide input on protocol development and operational feasibility assessments. Team Coordination: Collaborate with project teams and stakeholders to ensure smooth and efficient execution. Leadership: Drive clinical operations and cross-functional teams through the planning, execution, and reporting stages of clinical trials. Problem Solving: Proactively identify and address study-related challenges to maintain data quality and meet milestones. Recruitment Management: Monitor and optimize site-level recruitment to achieve enrollment targets. Project Oversight: Leverage project management tools to efficiently manage study timelines and budgets. Qualifications Experience: Minimum 5 years managing clinical studies from initiation to completion; remote and on-site monitoring experience preferred. Experience: Managing Global Phase 3 Trials from initiation to completion. Expertise: Hematology/Oncology experience is a must. Education: Bachelor's degree or equivalent experience in Life Sciences. Knowledge: In-depth understanding of ICH/GCP guidelines and FDA regulations. Flexibility: Ability and willingness to travel as required. Ready to Make a Difference? If this opportunity aligns with your expertise and passion for driving clinical excellence, we'd love to hear from you! Apply below or send your updated CV directly to me at the contact information provided. Contact: Jean-David Mandarin Clinical Associate Recruiter 📧 ******************************
    $78k-124k yearly est. 3d ago
  • Clinical Scientist

    Medasource 4.2company rating

    Clinical Research Coordinator Job In Raritan, NJ

    Remote 12 month contract with extensions The Clinical Scientist, Dermatology will be responsible for assisting in the development and execution of Medical Affairs sponsored and supported clinical programs for company products in the Dermatology therapeutic area and will partner with other Rheumatology team members, as well as real-world evidence, health economic and outcomes research, biostatistics, and commercial marketing personnel through integrated evidence teams (and other touchpoints) to formulate and execute scientific strategy on marketed products as well as address other medical questions and issues that arise from the field and experts in the Dermatology therapeutic area. The Clinical Scientist, Dermatology will also assist in the conduct/execution of clinical studies, advancement of Investigator Initiated Studies and lead or contribute to development of related study reports, abstracts and manuscripts, particularly where related to safety data and experience. **Responsibilities:** - Responsible for the development and execution of Medical Affairs sponsored and supported clinical programs for company products in the Dermatology TA. - Lead the day-to-day conduct of clinical studies of all types, including Phase IIIb/IV trials, registries, real-world evidence, collaborations, and investigator-initiated studies. - Actively partners with individuals in Dermatology TA and other groups inside and outside Medical Affairs (e.g. Other MA TAs, Biostats, GCO, Regulatory Affairs, QA and QC) to support Analysis Plans, safety data review for database locks and ensure compliance with study monitoring and other SOP/GCP requirements (and support audits, as needed). - Actively contributes as a subject matter expert on previous and new data on approved immunology products, and provide advice and input to the IET, Commercial, V&E and Medical Information Teams - Contributes to or leads the development of study reports, abstracts and manuscripts supported and sponsored studies, with a focus on safety analyses and experience. - Builds and manages effective relationships with KOLs and investigators related to Medical affairs studies and strategic initiatives. **Qualifications:** - MA/MS/PharmD/PhD preferred, ideally with focus on basic or medical science, public health, and/or epidemiology. - This position requires a minimum of 3 years of pharmaceutical industry experience with at least 2 years of clinical study, registry, or real-word evidence study experience strongly preferred. Overall, the position requires 8-10 years of work experience in total. - Experience with clinical studies end-to-end conduct (eg, protocol development, study planning/start-up/execution/close-out) and study medical monitoring/safety reporting is required. - Experience with data analysis, review and results interpretation is preferred. - Strong organizational skills, written and verbal communication skills are required. - Excellent time management skills with the proven ability to plan and track deliverables and timelines are required. - Ability to work in a matrix environment with cross functional teams is mandatory. - Energy and enthusiasm, Strong leadership skills, and the ability and desire to embrace building subject matter expertise are essential. Excellent oral and written communication and presentation skills are required
    $118k-149k yearly est. 30d ago
  • Lead Clinical Research Associate

    Global Channel Management

    Clinical Research Coordinator Job In Raritan, NJ

    Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Lead Clinical Research Associate needs: BS/BA, MS is desirable 5+ years of site management of which a minimum of 2 years field monitoring experience Knowledge of applicable standards and regulations for clinical trial Experience in Cardiovascular Therapeutic area IVD Stud Experience Medidata RAVE system Lead Clinical Research Associate duties: Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL). Additional responsibilities include: Implementation of enrollment and recruitment strategies Assistance in vendors' selection processes • Additional Information $45/hr 12 months
    $45 hourly 60d+ ago
  • Clinical Scientist Lead - Psychiatry (Director)

    Rayzebio 4.2company rating

    Clinical Research Coordinator Job 15 miles from Raritan

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. The Clinical Science Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. * Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team * Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trials * Ensures consistency across studies and provide oversight of all clinical studies within assigned area * May serve as a Clinical Trial Lead or Co-Lead as needed * May represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities * Serves as a key cross functional collaborator; initial point of escalation cross functions Key Responsibilities * Collaborate with Clinical Science Program Lead and Clinical Development Lead to support development of clinical development and lifecycle planning * Lead implementation of assigned clinical development and/or lifecycle plans * Maintain an advanced understanding of all protocols within assigned Program * Provide scientific and clinical leadership to support all activities to advance the assigned plans; Provide program/study/therapeutic area/skills training to team members * Represent Clinical Science Team on the Program Team as appropriate/requested * Support resourcing and budget planning activities for team * Review and present data and information to external investigators and internal stakeholders as needed * Identify and liaise with internal and external collaborators independently and oversee collaboration between clinical scientist and external partners for scientific advice * Lead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. Management * Author/Review abstracts/publications * Oversee, contribute to, and ensure quality execution of deliverables for all phases of assigned trials (start up/conduct/closure), through activities such as: * Evaluation of innovative trial designs * Protocol and ICF development * Site-facing activities * CRA training materials * Data quality activities; ensure consistent, quality data review across trial teams * Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities * Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) Qualifications & Experience * Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred) Experience Requirements: * 5+ years of experience in clinical science, clinical research, or equivalent * Experience in driving, managing and collaborating in a team/matrix work environment * Recognized internally and externally as a Therapeutic Area and Functional expert * Preferred experience in Neuroscience and/or Psychiatric Key Competency Requirements: * Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations * Ability to plan and manage * Advanced ability to analyze, interpret, and present data * Advanced knowledge and skills to support program specific data review, trend identification, data interpretation * Advanced knowledge of indication, therapeutic area, compound(s), competitive landscape and health authority requirements * Advanced medical writing and presentation skills * Ability to self-supervise, and act independently to identify/resolve program level issues * Proficient critical thinking, problem solving, decision making skills * Effective planning and time management * Advanced verbal, written and interpersonal skills (communication skills) * Adaptable and analytical * Strong presentation skills / leadership presence * Commitment to Quality * Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism * Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals) * Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools * Travel Required * Domestic and International travel may be required. Travel Required * Domestic and International travel may be required. The starting compensation for this job is a range from $182,000-$257,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. #li-hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
    $182k-257k yearly 24d ago
  • Lead Clinical Research Associate

    Integrated Resources 4.5company rating

    Clinical Research Coordinator Job In Raritan, NJ

    Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Title: Lead Clinical Research Associate Location: Raritan, NJ 08869 Responsibilities: LEAD CLINICAL RESEARCH ASSOCIATE: Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL). Additional responsibilities include: • Implementation of enrollment and recruitment strategies • Assistance in vendors' selection processes • Development, execution, management and compliance assurance of the Monitoring Plan • Review and approve trip reports, track scheduling, report submission metrics, site deviations and action items • Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. • Development of training materials and study tools for site and CRA use • Assistance in formation of the Adjudication Committee including oversight of documentation collection and filing into the Trial Master File Qualifications Qualifications: LEAD CLINICAL RESEARCH ASSOCIATE: • BS/BA, MS is desirable • 5+ years of site management of which a minimum of 2 years field monitoring experience • Knowledge of applicable standards and regulations for clinical trial • Proven oral and written communication skills • Proven planning skills; ability to create and track detailed project plans • Proven interpersonal, leadership, organizational and effective time management skills • Microsoft Office proficiency • Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion • Experience in Cardiovascular Therapeutic area • IVD Stud Experience • Medidata RAVE system Additional Information Kind Regards, Sabanaaz Shaikh Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
    $50k-75k yearly est. 60d+ ago
  • Assistant Research Coordinator

    Rutgers University 4.1company rating

    Clinical Research Coordinator Job 11 miles from Raritan

    Recruitment/Posting Title Assistant Research Coordinator New Jersey's academic health center, Rutgers Biomedical and Health Sciences (RBHS ) takes an integrated approach to educating students, providing clinical care, and conducting research, all with the goal of improving human health. Aligned with Rutgers University-New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and five centers and institutes that focus on cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research. Our faculty are teachers, clinicians, and scientists with unparalleled experience who advance medical innovation and provide patient care informed by the latest research findings. We offer an outstanding education in medicine, dentistry, pharmacy, public health, nursing, biomedical research, and the full spectrum of allied health careers. Our clinical and academic facilities are located throughout the state-at Rutgers University-New Brunswick, including Piscataway; and at locations in Newark, Scotch Plains, Somerset, Stratford, and other locations. Clinical partners include Robert Wood Johnson University Hospital in New Brunswick, Newark's University Hospital in Newark, and other affiliates. Through this community of healers, scientists, and scholars, Rutgers is equipped as never before to transform lives.Rutgers, The State University of New Jersey, is seeking an Assistant Research Coordinator for the Department of Emergency Medicine at the Rutgers Robert Wood Johnson Medical School. Under the direction of the Research Director, the Research Coordinator will oversee and participate in the coordination and conduct of clinical research and observational studies in Emergency Medicine. Current areas of faculty research interest and expertise include in-hospital cardiac arrest, social emergency medicine, and ultrasound. The successful candidate must be highly motivated, detail-oriented, and self-directed, with strong interpersonal skills. Among the key duties of this position are the following: * Be highly motivated to obtain knowledge on project-related research topics. * Recruiting, consenting, scheduling and interviewing study subjects. Collection of quantitative and qualitative data from subjects and/or medical records. Creation and management of documents for Institutional Review Board (IRB ) and other study related activities. * Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor. * Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms; prepares abstracted/coded data for processing/analysis. * Keep neat, thorough, and up-to-date records of procedures and analyses, using paper and electronic platforms. * Timely and accurate entry of data into research databases. Regularly audits database for errors and obtains missing information. * Participate in phone, electronic, and in-person communications and meetings with principal investigators and study team to support the development and improvement of programs. Union Description HPAE 5094 Benefits Rutgers offers a comprehensive benefit program to eligible employees. For details, please go to . Qualifications Minimum Education and Experience * Bachelor's Degree in a relevant science plus two (2) years experience. Certifications/Licenses Required Knowledge, Skills, and Abilities * Proficiency with Internet applications and in using various Microsoft Office applications such as Word, Excel, Power Point and Outlook, online search engines and fluency with learning new software applications. * Ability to manage multiple research projects simultaneously with high degree of accuracy and attention to detail. * Excellent interpersonal, organizational, communication (oral and written), and problem-solving skills. * Ability to interface effectively with all levels of management. Must work and communicate effectively with both internal and external team members. * Demonstrates flexibility to work in a collaborative environment. * Strong organizational and time management skills and ability to multitask and work well under pressure to meet time deadlines. * Self-starter who is detail oriented, analytical, has strong organizational skills and the ability to work independently * Ability to identify, analyze and solve problems. * Be highly motivated to obtain knowledge on project-related research topics. Preferred Qualifications * Master's Degree. * Experience with human subjects research and/or patient interaction in a clinical setting. * Experience with Institutional Review Board (IRB ) submission and manuscript preparation strongly. * Experience with grant writing and budgeting. * Interest in in-hospital cardiac arrest, social emergency medicine, and ultrasound. * Experience with REDCap database software and implementing REDCap surveys and databases. * Fluency in Spanish. Equipment Utilized Physical Demands and Work Environment * Physical Demands: Reading, standing, sitting, walking, talking and hearing. Lifting up to 25 lbs. * Work Environment: Office environment with moderate noise. Special Conditions Home Location Campus Downtown New Brunswick Location Details Immunization Requirements Under Policy 100.3.1 , if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Additional infection control and safety policies may apply. Prospective employees should speak with their hiring manager to determine which policies apply to the role or position for which they are applying. Failure to provide proof of vaccination for any required vaccines or obtain a medical or religious exemption from the University will result in rescission of a candidate's offer of employment or disciplinary action up to and including termination. Affirmative Action/Equal Employment Opportunity Statement It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. For additional information please see the Non-Discrimination Statement at the following web address: * * Yes * No
    $46k-64k yearly est. 29d ago
  • Sr. Manager, Clinical Research Scientist

    Taiho Oncology 4.4company rating

    Clinical Research Coordinator Job 15 miles from Raritan

    Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us. Hybrid Employee Value Proposition: At Taiho Oncology, we are dedicated to transforming the landscape of cancer treatment and improving patients' lives. As a Senior Manager, Clinical Research Scientist, you will play a pivotal role in our mission, leveraging your expertise to drive innovative clinical research and contribute to groundbreaking therapies. We offer a collaborative and inclusive work environment where your ideas and contributions are valued. Join us to advance your career, work with passionate and skilled professionals, and make a meaningful impact on the fight against cancer. At Taiho Oncology, you will find purpose, growth, and the opportunity to be at the forefront of cancer research. Position Summary: The Senior Manager, Clinical Research Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3. Additionally, this role position supports the responsible medical monitor in the execution of key tasks involved in the design, conduct, monitoring, analysis and reporting of clinical trials. Performance Objectives: Collaborates with other key team members (Medical monitor, Project Manager, Clinical Operations, Data Management, Biostatistics, PV, PK, Biomarkers and Medical Writing etc.), to deliver high quality clinical trial results. Use scientific expertise to support the creation of relevant high-quality clinical documents such as study protocols and clinical study reports (CSRs), investigator brochures, DSUR, NDA/MAA registration documents and publications. Reviews and summarizes ongoing clinical data (from EDC and listings) to monitor the quality of the study, ensure clean data flow into the study database and compliance with the protocol. Keeps the latest knowledge in clinical development through publications and scientific conferences and leverages the knowledge for designing and summarizing clinical studies. Keeps Sr. Medical Director current on status of clinical trials and provides ongoing risk assessments for the study conduct and operational risks. Performs other duties as required. Travel requirements: up to 25% Education/Certification Requirements: Masters level degree in pharmaceutical or related medical science is preferred. Bachelor's level candidates with substantive prior pharmaceutical experience will also be considered. Knowledge, Skills, and Abilities: 3-5 years of experience in drug development in pharmaceutical industry. At least 2 years in drug development industry in oncology and with previous exposure to clinical development, such as reviewing of the quality of ongoing and final clinical study data, protocols and CSRs, investigator brochures, DSUR, NDA/MAA registration documents and publications. Ability to critically review and interpret Clinical data. The pay range for this position at commencement of employment is expected to be between $155,550 and $183,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #LI-Hybrid Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email ************************. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records. The incumbent in this position may be required to perform other duties, as assigned.
    $155.6k-183k yearly 60d+ ago
  • Clinical Trial Manager II

    Lifelancer

    Clinical Research Coordinator Job 2 miles from Raritan

    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 Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters. Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meeting. Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution. Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (eg. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required. Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management. Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope. Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. Develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines. Provides feedback to line managers on staff performance including strengths as well as areas for development. May be assigned to larger, more complex trials. Qualifications What we're looking for Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Demonstrated ability to lead and align teams in the achievement of project milestones Demonstrated capability of working in an international environment. Demonstrated expertise in site management and monitoring (clinical or central) Preferred experience with risk-based monitoring Demonstrates understanding of clinical trial management financial principles and budget management Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills Good communication, presentation and interpersonal skills among project team and with sites Strong conflict resolution skills Demonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues Moderate travel may be required, approximately 20% 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 Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements. 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 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. The annual base salary for this position ranges from $90,000 to $ 175,000. 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. 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. Lifelancer ( ********************** ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. For more details and to find similar roles, please check out the below Lifelancer link. **********************/jobs/view/be7cad5ee84df77c8471f21289e6feeb
    $90k-175k yearly 16d ago
  • Clinical Research Scientist

    Thepharmadaily LLP

    Clinical Research Coordinator Job 15 miles from Raritan

    **Job Type:** Full Time **Education:** B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences **Skills:** Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. **The Role** This position may serve in a lead or co-lead role in the implementation of a clinical trial(s) within a program in alignment with the global development strategy. Works in collaboration with a Medical Director and Sr. level Clinical Research Scientist as indicated for ongoing clinical trial-related activities to provide high-quality and timely deliverables. **Responsibilities** * Lead or co-lead a less-complex clinical trial(s) within a program. * Works in collaboration with a Medical Director and Sr. level Clinical Research Scientist * Assists to execute the clinical trial in alignment with the clinical development plan (CDP) * Assists with the development of a trial protocol and to other study-related and regulatory documents * Assists in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities). * Contribute to the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis * Participates in country/site selection, feasibility assessment and engage in KOL interaction * Assists in the development of charters and provide support to coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, Adjudication and Safety Committees) * Assists in the development and review of study plans and serve as a liaison to project teams and CROs * Assists to prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted **Requirements** * PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline * Clinical research experience preferred. * Prior oncology/hematology drug development experience is a plus * Ability to work in a project oriented matrixed team environment * Excellent oral, written and interpersonal (communication) skills * Ability to travel to as needed For US based candidates, the proposed salary band for this position is as follows: $95,625.00---$159,375.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses. **About You** * You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment * You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving * You are a generous collaborator who can work in teams with diverse backgrounds * You are determined to do and be your best and take pride in enabling the best work of others on the team * You are not afraid to grapple with the unknown and be innovative * You have experience working in a fast-growing, dynamic company (or a strong desire to) * You work hard and are not afraid to have a little fun while you do so **Locations** Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate. **About Genmab** Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. **Our commitment to diversity, equity, and inclusion** We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on . Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
    31d ago
  • Sr. Manager, Clinical Research Scientist

    Madisonblack

    Clinical Research Coordinator Job 15 miles from Raritan

    Princeton, New Jersey, United States **Job Title** Sr. Manager, Clinical Research Scientist **Role type** Permanent The Senior Manager, Clinical Research Scientist assists in designing, executing, and reporting Phase 1-3 clinical oncology trials. The role supports the medical monitor with key tasks related to trial design, conduct, monitoring, analysis, and reporting. **Performance Objectives:** * Collaborate with team members (Medical Monitors, Project Managers, Clinical Operations, Data Management, Biostatistics, PV, PK, Biomarkers, Medical Writing) to deliver high-quality trial results. * Use scientific expertise to create essential clinical documents (study protocols, CSRs, investigator brochures, DSUR, NDA/MAA registration documents, publications). * Review and summarize clinical data to ensure study quality and protocol compliance. * Stay updated on clinical development knowledge and apply it to study design and summaries. * Inform the Sr. Medical Director about trial status and provide risk assessments. * Perform other duties as required. Travel up to 25%. **Education/Certification Requirements:** * Preferred: Master's degree in pharmaceutical or related medical science. **Knowledge, Skills, and Abilities:** * 3-5 years of drug development experience in the pharmaceutical industry. * At least 2 years in oncology with exposure to clinical development (reviewing data quality, protocols, CSRs, investigator brochures, DSUR, NDA/MAA documents, publications). * Ability to critically review and interpret clinical data. **EOE Statement:** Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. ***To find out more about Real, please visit*** **Your Privacy**
    31d ago
  • Clinical Research Associate

    Katalyst Healthcares & Life Sciences 4.2company rating

    Clinical Research Coordinator Job 16 miles from Raritan

    Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description: Ensure compliance with ICH - GCP guidelines and all pertinent government regulations for conducting clinical studies. Assist in preparation of protocols and documentation for clinical studies, entailing communication with consultants such as surgeons, radiologists and outside statisticians. Assist in the IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations. Contribute to overall data management such as case report form design, edit check review, data clarification process and evaluating and analyzing clinical data Recruit, qualify and train investigators and clinical site personnel (and laboratories, as applicable) for study participation. Assist with contract and budget preparation and negotiations. Coordinate activities of investigators and clinical site personnel to ensure compliance with the protocol and overall clinical objectives. Coordinate the organization of study regulatory files, inventory and all related study materials and supplies. Assure data integrity through proper on site monitoring, verification of source records, documentation of protocol deviations, and completion of written reports, in accordance with department Standard Operating Procedures (SOPs). Communicate with clinical sites to expedite the exchange of information and to ensure that clinical studies are kept on schedule and within budget. Assist with the implementation of investigator meetings and general clinical meetings (as applicable). Ensure subject safety in all areas of clinical research, following procedures to report AEs, SAEs and UADEs to clinical, regulatory and quality management. Contribute to obtaining government approvals and preparing progress reports for clinical studies. Promote good communication with investigational sites, within the clinical department, as well as between other Integra department members. Assist R&D, marketing, and other departments in performing their duties, as appropriate. Maintain awareness of current issues in clinical research by reading relevant literature and attending industry meetings and other training opportunities. Assist in various projects and other duties as assigned. Qualifications: Education: Bachelor's degree, preferably in a life science or scientific related field, or RN or BSN degree or 10+ years of recent and relevant clinical research/monitoring experience. Experience: Four year or more experience in clinical research, with a minimum of two to four years' experience in independent coordination of investigational site activity by on-site monitoring and site communications. Specific competencies: Intermediate knowledge and understanding of FDA regulations and ICH - GCP guidelines. Must work both independently and in a team environment. Proven track record of on-site monitoring of investigational sites and constructive site collaboration. Ability to review and interpret medical records through knowledge and general application of medical terminology. Excellent interpersonal, written communications, time management, and organizational skills. Detail oriented with good problem solving skills. Ability to manage multiple tasks and take ownership and workflow initiative. Proficient computer skills using Microsoft Office products. Experience with electronic data capture (EDC) is a plus. Presentation skills desired. PHYSICAL REQUIREMENTS: The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. Skills and Certifications: Bachelor's degree, preferably in a life science or scientific related field, or RN or BSN degree. Four year or more experience in clinical research. Qualifications Bachelor's degree, preferably in a life science or scientific related field Additional Information Good working knowledge of project management activities. Interpersonal and professional skills to interact at all levels including senior executives, contractors and colleagues. Good written and verbal communication skills and ability to present and critically discuss data in both internal and external discussions. Highly organized, with exceptional good analytical and reasoning capability, ability to multi-task and prioritize. Thorough knowledge on analytical & numerical skills.
    $52k-84k yearly est. 60d+ ago
  • Clinical Affairs/Research Associate (Hybrid)

    Tyber Medical

    Clinical Research Coordinator Job 38 miles from Raritan

    Full-time Description The Clinical Affairs / Research Associate will play a vital role in the successful execution of clinical registries and post-market surveillance activities within our regulatory and clinical affairs team. This position focuses on coordinating and supporting clinical research to ensure product safety, efficacy, and regulatory compliance as well as supporting the planning, and execution of Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF), Clinical Evaluation Plans (CEP), and Periodic Safety Update Reports (PSUR) / Post-market surveillance reports (PMSR). The ideal candidate should possess a strong understanding of regulatory compliance and clinical research methodologies. Effective collaboration with internal teams, research sites, and regulatory bodies is crucial to ensure all activities adhere to regulatory requirements, Good Clinical Practice (GCP), and company standards. Requirements Study Coordination and Management Assist in the planning and implementation of clinical research protocols. Coordinate with clinical sites to facilitate subject recruitment, retention strategies, and support overall study enrollment goals. Support day-to-day operations of assigned studies, ensuring adherence to protocol requirements, and timelines. Act as a contact for site staff and ensure clear communication regarding study updates. Data and Document Management Maintain and oversee study documentation, including source documents and study regulatory files. Ensure accurate data collection, entry, and quality control, perform data analysis, and working closely with the study management team to resolve discrepancies. Conduct regular site reviews of clinical data and information the study management team on items requiring resolution. Assist in the preparation and submission of clinical study documentation, including Clinical Evaluation Reports (CERs), study protocols, and study reports. Support the preparation of clinical data for regulatory submissions, including FDA submissions and CE mark applications. Assist with Post-Market Clinical Follow-up (PMCF) activities to collect data on the long-term safety and effectiveness of medical devices after market release. Support the tracking and reporting of clinical outcomes post-launch. Assist in the creation and execution of Clinical Evaluation Plans (CEP) for new and existing medical devices, including designing strategies to collect relevant clinical data and determining appropriate methodologies for product assessment. Contribute to the preparation of Periodic Safety Update Reports (PSUR) / Post-market surveillance reports (PMSR), ensuring that all safety and performance data from clinical studies and post-market surveillance are accurately summarized and reported in accordance with regulatory requirements. Regulatory and Compliance Ensure that all study-related activities comply with federal, state, and local regulations ICH-GCP guidelines, ISO 14155, applicable FDA, ISO 13485, and MDR regulations. Assist with Institutional Review Board (IRB) and Ethics Committee submissions, including protocol amendments, adverse event reporting, and study renewals. Assist with the preparation and submission of regulatory documents for clinical trials and post-market surveillance reports. Maintain up-to-date knowledge of industry standards and regulatory requirements to ensure adherence to guidelines and internal policies. Communication and Reporting Prepare study updates and metrics to internal and external stakeholders. Participate in regular study team meetings to discuss trial progress, challenges, and improvements. Contribute to the preparation of study reports, regulatory submissions, and manuscripts, as needed. Cross-functional Collaboration Work closely with internal teams (e.g., Regulatory Affairs, Quality Assurance, Product Development, etc.) and external partners (e.g., clinical research sites, CROs, investigators, and study participants) to ensure smooth execution of clinical studies and timely delivery of required reports. Collaborate with sites to address any logistical or administrative issues that may arise. Preferred Skills Certification in GCP Experience with medical device writing and clinical trials Familiarity with data analysis software and medical terminology Qualifications Bachelor's degree in life sciences, healthcare, or a related field 1-2 years of experience in clinical research/clinical affairs, within the medical device, healthcare industry, or CRO setting. Knowledge of FDA, EU MDR, ICH-GCP, ISO 14155, IRB, and ISO 13485 regulations. Proficient in Electronic Data Capture (EDC) systems and clinical trial management software. Excellent organizational skills with the ability to manage multiple tasks and prioritize effectively. Strong written and verbal communication skills, with attention to detail in documentation. Ability to work independently and as part of a cross-functional team in a fast-paced environment.
    $56k-88k yearly est. 60d+ ago
  • Senior Clinical Research Coordinator

    Vitalief

    Clinical Research Coordinator Job 11 miles from Raritan

    **Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications.** **Senior Clinical Research Coordinator** New Brunswick, NJ Full Time Experienced Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials. As a result, 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-DNI ** Apply for this position** Required*** Apply with Indeed Apply with Indeed
    $58k-90k yearly est. 31d ago
  • Clinical Trial Operations Manager I

    Artech Information System 4.8company rating

    Clinical Research Coordinator Job 2 miles from Raritan

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Manager Note: "candidates lacked the needed direct clinical supplies experience. To date we have seen several CRAs (which seems to be the closest thing and can work with on a good day), some pharmacists (not applicable at all), and some general experience non focused resumes. I understand that Clinical Supplies is niche and I understand that any person coming in will have to be trained, but there has to be some foundation. " DESCRIPTION: The Trial Supplies Operations Manager is responsible for the implementation of appropriate Clinical Supplies strategies and processes in order to achieve clinical study objectives in assigned programs. Responsibilities Include: Receives the Extended Synopsis/protocol and will provide feedback /comments to Project leaders and Clinical teams Obtain detail information about Clinical trials assigned including IP design, countries, blinded or open label trials, distribution strategy and other details. Work in collaboration with other functional team to identify forecasting strategy, IP/Ancillaries/comparators and other requirements for the assigned trials. Monitoring patient recruitment and adjust the resupply strategy as needed. Work in collaboration with internal and external stakeholders to plan the labeling requirements, packaging plan and domestic and international distribution. Initiates label request for clinical supplies meeting regulatory requirements for each market. Monitor the distribution plan including the IVR activities, making sure that IP are delivered in good condition for patients al all the time. Responsible for the Pre-Audit preparation for assigned trials, making sure that all documentation is correct and available for internal and external auditors. Interaction with local country representatives (IPM) and depots to coordinate over-labeling and/or rework operations. Constant interaction with quality (SQO), making sure that all activities related with assigned studies are within compliance. Qualifications Skills Strong verbal and written communication skills are required. Demonstrated ability to work effectively in a global matrix team environment Able to manage multiple projects and interact with different functional groups Work under pressure and tight timeliness Education:Education Bachelors Degree (Science) required A degree in Pharmacy (Pharm.D) or Master degree prefered. 3 - 5 years of hospital pharmacy or equivalent pharm Additional Information Neha Sharma Lead Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter
    $97k-138k yearly est. 60d+ ago
  • Senior Clinical Trial Manager

    Legend Biotech Corp 4.1company rating

    Clinical Research Coordinator Job 9 miles from Raritan

    Legend Biotech is seeking **Sr. Clinical Trial Manager** as part of the **Clinical Operations** team based **Remote.** **Role Overview** The Sr. Clinical Trial Manager will provide management and oversight of the Legend Biotech pipeline studies. The Sr. CTM will be responsible for all aspects of study set up, management and oversight of Legend Biotech pipeline studies. Job duties also include CRO oversight and a point of contact for clinical study project management, communications, daily operations for the clinical INDs being held by Legend Biotech USA, Inc. Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements is essential. The position involves working closely with the Associate Director of Clinical Operations and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, manufacture, supply chain, regulatory, project management, medical affairs, and quality. In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, SOP creation and development and represent the clinical trial operation function at internal and external meetings. **Key Responsibilities** * Responsible for all aspects of study set up, management and oversight of Legend Biotech pipeline studies. Job duties also include CRO oversight and point of contact for clinical study project management, communications, and daily operations for the clinical INDs held by Legend Biotech USA, Inc. * Experience in working with and overseeing Contract Research Organizations (CROs) and other external vendors is required. * Demonstrated ability to drive end to end clinical trial activities: i.e. experience in all aspects of study start-up and oversight of study execution and close out * Develop and manage comprehensive study timelines and metrics; clinical operation efficiency tools, management/oversight of external vendor deliverables reports and budgets. * Report on all aspects of the study progress at a granular level to Operations management. Effective, consistent & regular tracking of project (s). * Collaborates with following groups across the trial program: Data Management, Statistics, Clinical Supplies, Safety, etc. * Participates in all CRO study related calls and meeting, tracks actions, escalates issues and oversees all aspects of daily study operations. * Lead and co-lead internal study operational calls and meetings * Collaborate with the Director of Clinical Operations on study budget development, financial forecasting/budgeting management and vendor & site payments. Ability to identify issues and risks, develops and manage mitigations and/or escalate risks appropriately. * Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance. Efficient process and system thinker * Daily interaction with the study CRO project manager and Sr. Clinical Trial Manager * Collaborates in the preparation and/or review of study-related documents (e.g., Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals). * Ensures audit-ready condition of clinical trial documentation including central clinical files. * Collaborates in the writing and review of study protocols, informed consents and amendments. * Ensures the assigned clinical trials executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. * Ensure Trial Master Files (eTMFs) are properly maintained. * Ability to manage and collaborate on complex protocols within a matrix environment (Data Management, Safety, outsourcing and vendor alliance management). * Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines. * Comfortable multi-tasking in a fast-paced small company start-up environment and able to adjust workload based upon changing priorities. Adaptable / flexible, self-starter (willing and able to adjust to multiple demands, sometimes beyond job descriptions and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism) * Excellent team player but also independently without significant oversight * Strong Self-Starter and hardworking individual, willingness and ability to fill functional gaps in a small organization. **Requirements** * Minimum degree requirements of a Bachelor's Degree (BA, BS) in scientific or health care discipline preferred. * 7+ years of managing studies at a pharmaceutical, biotech or CRO * 3+ years of oncology clinical research experience required * Experience working in small biotech/pharma environment * Cellular/Gene therapy (CAR-T) experience a plus * CRO/Multiple vendor oversight on complex studies experience required 7. Demonstrated ability to multi-task, wear multiple hats and manage high performance demands * Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail * Project Management (CRO/biotech) experience a plus * Regulatory authority inspection experience a plus * Experience managing multiple studies * Experience managing complex or global trials preferred familiarity with regulatory process in global studies * Ability to travel as necessary (approximately 10 - 15 %) * Effective oral, written and interpersonal communication skills * Strong communication skills * Sop development preferred * Strong organizational and project management skill and the ability to multitask * Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project) * Oncology Therapeutic Experience required * Excellent working knowledge GCP, FDA and ICH Guidelines #Li-JK2 #Li-Remote If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
    $82k-129k yearly est. 30d ago
  • Clinical Research Coordinator- Entry level

    Eurofins 4.4company rating

    Clinical Research Coordinator Job 9 miles from Raritan

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Primary Duties and Responsibilities: Assist in the conduct of clinical trials as specified by the study protocol under the supervision of designated Principal Investigator and departmental management Record observations, measurements, and test results, as required Provide a professional experience to test subjects, and answer all inquiries, as appropriate Assist in the preparation of test materials, as needed Perform data entry and data review to ensure study quality Adhere to all Standard Operating Procedures to ensure consistency and quality work across CRL Efficiently time manage multiple projects Succinctly communicate day to day project details to both department manager and Principal Investigator Perform department specific procedures as qualified by training and evaluation of proficiency Qualifications Qualifications Computer/Instrument Literacy Exceptional detail-orientation Excellent verbal and written communication skills Ability to be a self-starter and work cooperatively with other professionals in a medium-sized company environment Good typing skills Problem solver Quick learner Multi-tasking skills Proficiency in Office Software programs Authorization to work in the United States indefinitely without restriction or sponsorship Customer service experience required Education and Experience: Bachelor's degree in science Additional certifications preferred (cosmetologist, aesthetician, etc) At the discretion of senior management, additional experience may qualify an individual in place of a Bachelor's degree Additional Information COMPREHENSIVE BENEFITS PACKAGE & COMPENSATION As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options. Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
    $50k-74k yearly est. 15d ago
  • Clinical, Part-Time

    Union County College 4.2company rating

    Clinical Research Coordinator Job 12 miles from Raritan

    Position Title Clinical, Part-Time Campus Plainfield Department Practical Nursing Full-time, Part-time, Adjunct Part Time Exempt or Non-Exempt Regular,Temporary, or Grant Regular General Description Clinical, Part-time responsibilities include the supervision and evaluation of clinical lab and/or patient care experiences as assigned by Program Director. Characteristics, Duties, and Responsibilities * Collaborate with FT and PT faculty members to implement desired clinical instruction. * Demonstrate required psychomotor skills for students. * Prepare and post patient care assignments. * Supervise students' skill practice and clinical patient care. * Communicate with personnel on clinical units, including pre- and post-care conferences. * Correct inaccurate or unsafe skill performance by students. * Evaluate critical skill performance. * Maintain a safe practice environment. * Report on student performance to full-time and Part-time faculty members or coordinator. * Demonstrate professional accountability by being punctual for class and obtaining coverage if necessary for absences. * Utilize principles of current nursing practice for clinical experiences. * Adhere to professional standards and legal guidelines of practice. * Attend scheduled departmental staff meetings. Education Requirements * Master's degree in nursing and current N.J. RN nursing license. Experience * Minimum of 3 years clinical nursing experience required. * Teaching experience is preferred. Competencies and Skills Required * Demonstrated mastery of subject matter or discipline o Clinical and/or instructional experience in the specific nursing field (ex. Pediatrics) o Demonstration of clinical nursing techniques Physical Demands and Work Environment * This position's duties are normally performed in a typical interior/residence work environment, based on the activity scheduled. * Some physical effort required; however, the employee must occasionally lift and/or move up to 25 pounds. * No or very limited exposure to physical risk. * Some travel required. * Ability to stand and walk for extended period of time in clinical patient care setting. Salary $65.00 per hour Additional Information Union County College does not discriminate and prohibits discrimination, as required by state and/or federal law, in all programs and activities, including employment and access to its career and technical programs. Union County College is an EEO/AAP Employer/Protected Veteran/Disabled ================ Disclaimer: This outlines the general nature and key features performed by various positions that share the same job classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties and qualifications required of all employees assigned to the job. Nothing in this job description restricts management's right to assign or re-assign duties to this job at any time due to reasonable accommodations or other business reasons. Terms of Employment Flexible schedule to meet department needs. Some evening, weekends, and extended hours will be required. Ability and willingness to travel on short notice to all on and off- campus sites as needed by the college. Employee must establish primary residency in New Jersey within one year of appointment unless an exemption applies. Part-time hours not to exceed 25 per week. Travel to the campus and health care agencies, and hours outside of the traditional weekday work schedule may be required, including evenings and weekends. Posting Detail Information Open Date 07/01/2024 Close Date Open Until Filled Yes
    $65 hourly 30d ago
  • Clinical Research Coordinator

    Actalent

    Clinical Research Coordinator Job 15 miles from Raritan

    We are seeking a highly motivated and experienced Clinical Research Coordinator to join our prestigious academic research institute. This role involves working on high-profile studies with well-known sponsors, utilizing state-of-the-art equipment. The ideal candidate will have a minimum of two to three years of clinical research experience, preferably in hematology, and be comfortable interacting with physicians. Responsibilities * Coordinate and oversee clinical research studies from initiation to completion. * Ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. * Enroll and consent patients for clinical trials. * Conduct chart reviews and maintain accurate patient records. * Manage electronic data capture (EDC) systems for data entry and reporting. * Monitor and report adverse events using CTCAE 4.0. * Collaborate with physicians and other healthcare professionals to ensure smooth study operations. * Prepare and submit regulatory documents to the Institutional Review Board (IRB). Essential Skills * Minimum of two to three years of clinical research experience. * Proficiency in Good Clinical Practice (GCP) guidelines. * Experience with cancer medications and adverse event reporting using CTCAE 4.0. * Effective communication and writing skills. * Ability to multi-task and problem solve. * Strong computer skills, including proficiency in MS Office Suite. * Knowledge of IRB and human research protection regulations. Additional Skills & Qualifications * Hematology experience preferred. * Demonstrated ability to work both independently and as part of a team. Work Environment This position is based in a fast-paced environment within a large campus. The clinical research coordinator will work at a satellite site in a cancer center, alongside one clinical research nurse and one other clinical research coordinator. This role offers great exposure to a growing team and opportunities to work with state-of-the-art equipment. Pay and Benefits The pay range for this position is $30.00 - $35.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Princeton,NJ. Application Deadline This position will be accepting applications until Jan 17, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $30-35 hourly 15d ago
  • Clinical Trial Operations Manager

    Saviance Technologies

    Clinical Research Coordinator Job 2 miles from Raritan

    Saviance Technologies is a global provider of Enterprise Technology Solutions for the US Healthcare Sector focusing on the latest technology SMAC stack (Social, Mobility, Analytics and Cloud). We provide innovative solutions and enable meaningful Use of IT by designing patient care & community portals, collaboration applications, big data insights for wellness & population health, ICD-10 resources and process automation. Our clients are distinguished hospitals, healthcare institutions and manufacturers of consumer healthcare products. Saviance has enabled them to achieve critical objectives such as increased projects visibility across the organization, improved knowledge management, enhanced technological prowess, improved productivity, better return on investment and therefore the ability to make value-added business decisions. Job Description The CTOM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use and registries) including oversight of data management activities in compliance with GCPs, SOPs and standards within established timelines and budgets. The CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with other functions (e.g. Medical Operations, Monitoring Team, Biostatistics) and with the CRO, for outsourced trials. Capable of interacting effectively with scientists, support functions, subject matter experts and managers within and outside department; serve as internal consultant on assigned area and liaise with external organizations on projects. - Strong interpersonal and communication/presentation skills (verbal and written); - Ability to handle multiple tasks and to prioritize, strong organizational skills - Leadership & Project Management abilities: ability to conduct effective and efficient international team meetings (Clinical Trial Team, expert meeting, etc), demonstrate good collaboration skills, have a positive, “can do” attitude, be proactive - Capability to perform effective vendor and stakeholder management including budget management, active and effectual oversight of CROs - Possess a solid understanding of data management activities (eCRF development from protocol design, database concepts, data flow, data cleaning, etc.) - Decision-making and problem-solving skills - Ability to work autonomously and to efficiently & effectively provide status reports - Ability to anticipate, identify and timely escalate issues and to define appropriate action plans - Ability to anticipate, identify and mitigate risks, including their likelihood, scope and impact and to develop CAPAs - Good cross-functional team leader who fosters team spirit and team motivation (team work) - Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs - Ability to work in an international environment with internal and/or external partners (CROs etc) - Strong English skills (verbal and written if English is the second language) - Competence to adapt and be flexible to change and managing internal and external impediments - Ability to “think outside of the box” and make adjustments/create action plans to meet timelines. - Prior experience with pediatric studies preferred - Able to work on site at least 3 days per week Qualifications 10 years of experience in pharmaceutical industry or clinical-related discipline including at least 7 years clinical research experience, including 4 years of strong trial operations management experience across all study periods (start-up, maintenance and closure). Additional Information Regards Rahul Kumar ************
    $78k-124k yearly est. 60d+ ago
  • Clinical Research Coordinator

    Hackensack Meridian Health, Inc. 4.5company rating

    Clinical Research Coordinator Job 14 miles from Raritan

    JFK MEDICAL CENTER Edison, New Jersey * **Requisition #** 2024-152420 * **Shift**Day * **Status**Full Time with Benefits Our team members are the heart of what makes us better. At **Hackensack Meridian *Health*** we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change. The **Clinical Research Coordinator** is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which is assigned. **Responsibilities** A day in the life of a **Clinical Research Coordinator** at Hackensack Meridian *Health* includes: * Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol. * In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study. * Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator. * Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversee subject enrollment to ensure that informed consent is properly obtained and documented. * Coordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams as required. * Works with the study team to draft/create study specific study orders, billing templates and study calendars as necessary. * Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols. * Monitors all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies. * Registers protocol patients with appropriate statistical centers as required. * Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts. * Acts as principal investigator's representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnel. * Along with clinical research nurses, maintains accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required. * Works closely with clinical research finance to ensure study patient's clinical trial related activities are billed appropriately. * Schedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit. * Maintains contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data. * Ensures compliant maintenance of all required records of study activity including case report forms, drug dispensation records, or regulatory forms. * Oversees and directs the requisition, collection, labeling, storage, or shipment of specimens. * Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. * Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. * Identifies protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions. * Organizes space for study equipment and supplies. * Participates in the development of study protocols including guidelines for administration or data collection procedures. * Contacts outside health care providers and communicate with subjects to obtain follow-up information. * Reviews scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues. * Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. * Attends research meetings and conferences as required. * Participates in staff meetings and in-service education as necessary. * Other duties and/or projects as assigned. * Adheres to HMH Organizational competencies and standard of behavior. **Qualifications** **Education, Knowledge, Skills and Abilities Required**: * BA/BS diploma/degree in science or healthcare field. * Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research. * Strong attention to detail and customer service focus. * Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential. * Excellent organizational, presentation, documentation and interpersonal skills. * Excellent written and verbal communication skills. * Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms. **Education, Knowledge, Skills and Abilities Preferred**: * Education on human subject research and GCP. **Licenses and Certifications Preferred**: * SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC). If you feel that the above description speaks directly to your strengths and capabilities, then please apply today! **HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER** All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran. **Our Network** **Hackensack Meridian *Health* (HMH) is a Mandatory Influenza Vaccination Facility** As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience. **WE KEEP GETTING BETTER** At Hackensack Meridian *Health*, we help our patients live better, healthier lives - and we help one another succeed. Here, competitive benefits are just the beginning. It's also about how our team members support one another and how we show up for our community. Together, we're ready to transform health care and advance our mission to serve as a leader of positive change.
    $53k-72k yearly est. 30d ago

Learn More About Clinical Research Coordinator Jobs

How much does a Clinical Research Coordinator earn in Raritan, NJ?

The average clinical research coordinator in Raritan, NJ earns between $43,000 and $90,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.

Average Clinical Research Coordinator Salary In Raritan, NJ

$62,000
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