Clinical research associate jobs in North Hempstead, NY - 273 jobs
All
Clinical Research Associate
Clinical Research Scientist
Study Coordinator
Clinical Research Assistant
Clinical Trial Manager
Clinical Coordinator
Principal - Clinical Trial Supply Management
Infosys Consulting 4.4
Clinical research associate job in New York, NY
Principal Consultant- Clinical Trial Supply Management for Manufacturing, Packaging and Distribution
Infosys Consulting is seeking smart, self-driven, high-energy professionals with strong communication skills, intellectual curiosity, and a deep passion for Clinical Trial Supply Management (CTSM) in the Life Sciences domain. The ideal candidate brings a strong blend of domain expertise in clinical supply operations, manufacturing, packaging, labeling, and distribution, along with business transformation consulting experience and excellent stakeholder management skills.
This role will play a pivotal part in shaping the next generation of AI-enabled CTSM solutions, where intelligent, autonomous, and goal-driven AI agents proactively plan, optimize, monitor, and orchestrate end to end clinical supply operations.
As a Principal Consulting professional, you will leverage your extensive professional services experience to lead large-scale transformations and help mature Infosys Consulting's CTSM and Life Sciences capabilities. You will collaborate closely with pharmaceutical and biotech clients to deliver AI-led business and digital transformations, while contributing to strategic initiatives such as thought leadership, capability incubation, and knowledge management, enabling clients to navigate the evolving global clinicalresearch landscape.
RESPONSIBILITIES
Be responsible for the delivery of measurable business outcomes for leading pharmaceutical and biotechnology clients, with a focus on manufacturing, packaging, labeling, and distribution of clinical trial supplies.
Provide strategic leadership and thought partnership on AI-led transformation programs, reimagining CTSM operating models across demand forecasting, supply planning, production scheduling, and distribution execution.
Drive the design and deployment of intelligent CTSM solutions, leveraging autonomous AI agents for Predictive demand and supply planning, Scenario-based manufacturing and packaging optimization.
Partner with technology and data teams to conceptualize and implement AI use cases across CTSM, including self-learning agents that continuously optimize Batch sizing and manufacturing runs.
Enable clients to transition from reactive, rule-based planning to autonomous, goal driven supply ecosystems that adapt in real time to protocol amendments, enrollment variability, and geopolitical disruptions.
Execute consulting engagements within a global delivery model, collaborating with cross-regional and cross-functional teams as part of a high-performing consulting community.
Lead complex, multi-vendor and multi-stakeholder programs spanning clinical operations, supply chain, quality, IT, and external partners.
Act as a trusted advisor to senior client stakeholders, influencing decision-making through data-driven insights and future-state visioning.
Mentor and coach consulting team members through both formal performance management processes and ongoing informal feedback.
Contribute to the growth and reputation of Infosys Consulting by developing new CTSM and Agentic AI-led offerings, authoring whitepapers, point-of-view documents, and thought leadership articles.
Participate actively in firm-building initiatives, community events, and internal knowledge-sharing forums.
BASIC QUALIFICATIONS
Bachelor's degree or foreign equivalent required. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
Overall experience of 7+ years, with at least 3+ years of post-MBA consulting experience in clinical manufacturing and operations with Lifesciences clients.
Experience in leading CTSM engagements for Life Sciences clients.
Strong understanding of Clinical Trial solutions in the value chain area of Study Master Design and Forecasting/Planning
In depth understanding of managing clinical operations using IxRT (Interactive Response Technology)
Experience in developing proposals, building tools and accelerators for CTSM related services.
Ability to handle conversations with senior business and technology leaders from client teams.
Ability to build engaging client presentations (Expertise on MS PowerPoint, MS Word, MS Excel, MS Project).
Good understanding of disruptive digital technologies
Strong executive presence and ability to interact with CxO level
A proven track record of leading and managing both large and small, global and local teams
Manage and build long-term client relationships
Candidates authorized to work for any employer in the United States without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time
PREFERRED QUALIFICATIONS
An MBA with an advanced degree or equivalent experience
Implementation experience in any Digital Supply Chain solutions - SAP IBP, Kinaxis Rapid Response, O9, E2Open, OMP etc. will be preferred.
Implementation experience of Clinical Trial Supply Chain solutions with SAP ICSM
Strong client-facing skills include presentations to senior leadership, advice and consult with clients.
Ability to provide guidance to stakeholders in understanding business value of the initiative.
Estimated annual total compensation range for this role for the New York, NY and Bridgewater, NJ area is $168,000 to $234,000.
EEO/About Us :
Benefits
Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits:
Medical/Dental/Vision/Life Insurance
Long-term/Short-term Disability
Health and Dependent Care Reimbursement Accounts
Insurance (Accident, Critical Illness , Hospital Indemnity, Legal)
401(k) plan and contributions dependent on salary level
Paid holidays plus Paid Time Off
About Us
Infosys Consulting is the global management and technology consulting practice of Infosys, a global leader in technology services and consulting. We combine the power of time-tested methodologies, people-driven innovation and disruptive technology to enable leaders of the world's top brands pursue a path of smart transformation. Together with our clients, internal and external partners, we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants:
• Ability to design and implement end-to-end solutions at scale
• A flat organization structure with direct access to our senior-most leaders
• An entrepreneurial environment full of bright, highly motivated consultants
• Opportunities for motivated consultants to impact local communities
• The ability to design your career and drive your professional learning and development
• A truly global culture
EEO
Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability
$168k-234k yearly 2d ago
Looking for a job?
Let Zippia find it for you.
RLA/Social Studies HSE Coordinator
Commonpoint
Clinical research associate job in New York, NY
Commonpoint is seeking to hire an HSE Coordinator for the Advance & Earn Program at its Bronx Center.
The goal of the Advance & Earn Program is to provide a career pathway for opportunity youth through a continuum of services including literacy and math facilitation, HSE test preparation, work readiness training, college and career exploration, paid work experience, advanced occupational training, and industry credential attainment. The programs support opportunity youth at any educational level, providing on-ramps at various levels through three program components, each supported by case management and wrap-around services.
DUTIES AND RESPONSIBILITIES:
The HSE Coordinator will:
● Develop lesson plans according to the various learning styles of program participants.
● Facilitate groups with the goal of improving literacy skills.
● Identify ways to connect classroom learning with real-world applications, ensuring that participants understand how to apply skills in workplace environments.
● Coordinate with program staff to ensure that participants' progress is being appropriately tracked and supported.
● Continually assess student progress toward mastery of standards and keep students and staff well informed of student progress by collecting and tracking data, providing daily feedback and weekly assessments.
● Provide necessary accommodations and modifications for the growth and success of all students.
● Attend professional development workshops and learning communities that will discuss RLA and Social Studies subtests, as well as curriculum development for the GED exam.
● Administer and utilize standardized assessments to develop curricula targeting the educational challenges of the students.
● Monitor students' performance and attendance for required reporting systems.
● Assist in the evaluation of participant engagement and curriculum effectiveness.
● Collaborate with case managers and program leads to ensure participants' holistic success in the program.
● Maintain flexibility to support program and agency-wide goals as needed
● Implement strategies to maximize student retention.
QUALIFICATIONS & REQUIREMENTS:
Required & Preferred Qualifications
● Bachelor's Degree in Education or comparable field required.
● Minimum of two years of experience overseeing young adult learners of varied ages, levels, and diverse cultural backgrounds.
● Knowledge of ABE and GED curricula, testing procedures, and requirements.
● Demonstrated ability in youth development
WORKING CONDITIONS
● Participation in all staff meetings and staff training seminars.
● Participation in agency-wide programs and program committees, as assigned.
● Active involvement as a supervisee in the supervision process.
● Support the mission of Commonpoint.
● Other tasks appropriate to the Commonpoint staff, as assigned.
BENEFITS AND PERKS
The benefits package includes comprehensive health, vision, and dental insurance, along with life insurance and a pension plan. Employees can take advantage of a flexible spending account and commuter benefits to help manage expenses. Paid time off (PTO) and floating holidays provide flexibility for personal time and work-life balance. The agency also offers a voluntary 403(b) retirement plan for additional financial security. Employees can enjoy various agency perks, including access to fitness centers, pool clubs, and discounts on agency programs. Additionally, the agency supports professional development through a scholarship program and a mentorship program.
JOB DETAILS
Annual Salary: $50,000 - $55,000
Non-Union Position
Location: Commonpoint Bronx Center, 1665 Hoe Ave, Bronx, NY 10460
How to Apply
Send resume and cover letter to Zachary Smith at **********************
$50k-55k yearly 5d ago
Physician Assistant / Clinical Research / New York / Locum Tenens / Physician Assistant-Certified
Manhattan Medical Arts
Clinical research associate job in New York, NY
Physician Assistant
Join our dynamic healthcare team as a Phyician Assistant dedicated to providing high-quality patient care in a fast-paced environment. As a Physician Assistant, you will play a crucial role in delivering comprehensive healthcare services to patients, collaborating with physicians and other healthcare professionals to ensure optimal patient outcomes.
Responsibilities:
- Conduct thorough patient assessments, including medical history reviews and physical examinations.
- Develop and implement individualized care plans for patients, focusing on preventive care, health maintenance, and disease management.
- Collaborate with interdisciplinary teams to coordinate patient care and ensure continuity of treatment.
- Offer health coaching and education to patients on disease prevention, medication management, and lifestyle modifications.
- Maintain accurate and detailed medical documentation in compliance with regulatory standards.
- Participate in clinicalresearch activities and contribute to the advancement of healthcare knowledge and practices.
- Engage in utilization review processes to optimize healthcare resource allocation and patient outcomes.
Qualifications:
- Valid Physician Assisitant license in New York.
- Certification as a Physican Assistant from an accredited certifying body.
- Proficiency in medical documentation systems and electronic health records.
- Strong clinical skills with a focus on evidence-based practice.
- Excellent communication skills with the ability to interact effectively with patients, families, and colleagues.
- Demonstrated commitment to ongoing professional development and continuing education.
Join our team, where you can make a difference in the lives of patients every day. We offer competitive compensation, opportunities for growth, and a supportive work environment dedicated to excellence in patient care. Apply now and embark on a rewarding career as a Physician Assistant with us.
Job Type: Full-time
Pay: $140,000.00 - $160,000.00 per year
Benefits:
Dental insurance
Employee discount
Flexible schedule
Health insurance
Life insurance
Paid time off
Vision insurance
License/Certification:
PA-C (Required)
Work Location: In person
$39k-57k yearly est. 1d ago
Physician Assistant / Clinical Research / New York / Locum Tenens / Physician Assistant - Clinical Research (Sub-Investigator)
Brooklyn Clinical Research
Clinical research associate job in New York, NY
Physician Assistant ? ClinicalResearch (Sub-Investigator)
Brooklyn ClinicalResearch was founded to increase access to clinical trials for underrepresented populations. Clinical-trial enrollment should accurately represent the broader population. In meeting this objective, we help improve therapeutic efficacy and safety for all individuals.
Position Overview:
We are seeking a clinically adept, highly motivated Physician Assistant to join our growing research team as a Sub-Investigator. This is a hands-on clinicalresearch role, working alongside our full-time Principal Investigator (MD) to conduct industry-sponsored clinical trials.
The ideal candidate will thrive in a fast-paced, dynamic environment where flexibility, strong clinical decision-making, and attention to detail are essential. You will receive full training in clinicalresearch and GCP, and you will play a key role in the daily conduct of clinical trials ? performing protocol-specific assessments, managing study visits, and ensuring participant safety and regulatory compliance.
Key Responsibilities:
Serve as a Sub-Investigator on assigned clinical trials under supervision of the Principal Investigator.
Perform protocol-required medical evaluations, including detailed histories, physical exams, safety assessments, and medical oversight of study participants.
Administer investigational products (e.g., vaccines, injectables) according to protocol.
Perform and oversee clinical procedures including phlebotomy, vital signs, ECGs, and other protocol-specified tests.
Assess and document adverse events and serious adverse events according to FDA and Sponsor guidelines.
Maintain thorough, timely, and accurate source documentation and electronic data entry (EDC, eSource, CTMS).
Collaborate closely with clinical coordinators, regulatory staff, sponsors, and CROs.
Participate in monitoring visits, audits, and inspections.
Maintain comprehensive knowledge of study protocols, informed consent documents, and regulatory requirements.
Participate actively in team meetings, contributing to ongoing process improvement as our site grows.
Qualifications:
Graduate of an accredited Physician Assistant program (required).
Active Physician Assistant license in New York State (required).
Prior clinicalresearch experience is a strong plus but not required ? training will be provided.
Current BLS/CPR certification.
Key Attributes for Success:
Excited to work in a fast-paced clinical environment where protocols and patient needs can vary daily.
Strong clinical acumen and independent judgment.
Detail-oriented with excellent documentation skills.
Highly organized with the ability to manage multiple protocols simultaneously.
Excellent communication and teamwork skills.
Commitment to patient safety, protocol adherence, and research integrity.
Spanish fluency or medical Spanish is a plus but not required.
Position Details:
Full-time, salaried position, Monday?Friday. Occasional weekend work may be required during high-volume vaccine periods.
Anticipated Start Date: Late July or Early August 2025
Salary Range: $140,000 to $170,000 depending on experience.
Why Join Us:
This is an excellent opportunity for a PA who is interested in advancing their career into clinicalresearch while maintaining direct patient interaction. You will be a key member of a high-performing, mission-driven team with meaningful opportunities for professional growth as our research site expands.
Job Type: Full-time
Pay: $140,000.00 - $170,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance
Medical Specialty:
Addiction Medicine
Emergency Medicine
Endocrinology
Hospital Medicine
Infectious Disease
Internal Medicine
Interventional Cardiology
Neurology
Pain Medicine
Primary Care
Urgent Care
Schedule:
Monday to Friday
No nights
License/Certification:
New York State Physician Assistant License? (Required)
Ability to Commute:
Brooklyn, NY 11226 (Required)
Work Location: In person
The Clinical Coordinator is responsible for the complex, multi-disciplinary coordination of specialty patient population(s), developing, evaluating and revising care pathways based on assessments conducted through engagement with the patient, family and multiple departments and disciplines. The Clinical Coordinator interfaces directly with MSH Departments, Administrators, Nursing, Medical and Quality leadership, and clinical staff and coordinates care for a patient population regarding the clinical, educational and operational impact of all care delivery, and outcome measures.
Responsible to:
This position reports directly to discipline leadership with a professional line to MSH Nursing or related disciplines professional practice leadership.
Responsible for:
Developing and implementing a plan of care for a specialty patient population, and/or specialty specific standards of care organization wide.
Responsibilities
1.Clinical Leadership
Coordinates clinical care within a designated specialty, in conjunction with Nursing, Social Work, Care Management, and other related disciplines, Medical and Quality leadership, coordinates care across multiple departments and services within the context of the specialty program including the clinical plan of care, quality assessment and improvement processes.
Establishes and implements short- and long-term goals, objectives, policies and operating procedures to ensure a high level of performance in nursing care delivery to the specialty patient population.
Organizes and leads in the execution of day-to-day patient care coordination, as appropriate to program objectives and areas of clinical expertise.
Provides consultation and education to members of the interdisciplinary team specific to the clinical specialty service, relative to the coordination of care for the specialty patient populations.
Promotes an interdisciplinary approach to patient care delivery.
Serves as a resource for patients and their families.
Acts as a patient advocate utilizing the Patient Bill of Rights.
Participates in promoting and maintaining a safe and therapeutic environment.
2. Development
Serves as a resource to leadership and staff in the development and implementation of nursing standards consistent with the established model of care.
Maintains leadership competency by participation in continuing education, professional organizations and other related activities.
Supports academic affiliations for purposes of providing clinically enriching experiences for students of nursing and other related clinical disciplines.
Works collaboratively with clinical leadership and supportive resources to ensure that patients have access to comprehensive interdisciplinary patient and family educational programs throughout their care trajectory.
3. Professional Practice
Supports the mission, philosophy, goals and objectives of the Department of Nursing or Related Discipline and The Mount Sinai Hospital.
Maintains clinical competencies, supports relationship centered care, the professional practice model, the care delivery model and is responsible and accountable for their own nursing practice.
Advocates the highest standards of nursing or discipline related practice.
Approaches patients, families and other members of the health care team in a professional, respectful manner.
Serves as a clinical role model and resource to the nursing staff.
Serves as a professional resource to other members of the health care team.
Demonstrates professional involvement by:
Attending and participating in workshops, seminars, and courses as presenter or author.
Keeping abreast of current literature and trends in practice.
Participating in related professional organizations.
Considers ethical issues in professional nursing practice.
Treats co-workers, patients and families with dignity and respect.
Maintains attendance and punctuality record in accordance with departmental standards.
Adheres to dress code in accordance with departmental policy.
4. Administrative Practice
Collaborates with other members of the health care team in the development, implementation, and ongoing review of policies, procedures, and standards of care for designated patient populations.
Demonstrates knowledge of hospital, departmental and care center standards, policies, procedures and guidelines as well as regulatory agency standards. Assures readiness for Joint Commission and other agency surveys and presents related programs during Joint Commission and other agency visits.
Participates in the development and implementation of continuous quality improvement programs to support the professional practice model and care delivery systems
Participates in quality management activities including identifying and communicating issues of performance improvement and risk in a timely manner, using chain of command.
Leads and participates in committee activities
Qualifications
Education Requirements: Bachelor's degree in specific discipline (i.e., Bachelor of Science in Nursing) is required. Masters degree in health related field is preferred.
Certification in specialty field is preferred
Experience Requirements: 2 years' experience in specialty clinical field
Licensing and Certification Requirements (if applicable): Current NYS nurse licensure
BCLS certification Required Issuing Authority: AHA
Collective bargaining unit: NYSNA-MSH
About Us
Strength through Unity and Inclusion
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
About the Mount Sinai Health System:
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
Equal Opportunity Employer
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.
$57k-74k yearly est. 8d ago
Clinical Research Associate II
Allen Spolden
Clinical research associate job in Newark, NJ
Responsible for providing ClinicalResearch support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinicalresearch functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1 -2 years of clinicalresearch experience or equivalent experience or training
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
$53k-83k yearly est. 60d+ ago
Director, Clinical Research Scientist
Cellectis
Clinical research associate job in New York, NY
Cellectis' Clinical Sciences (CS) organization is seeking a highly motivated and experienced clinicalResearch Scientist to support the both the development and execution of our innovative proprietary UCART allogeneic CART cell therapies programs.
The Director, ClinicalResearch Scientist participates in design and implementation of the development strategy and supports the Clinical Science Physicians with various deliverables necessary for effective and efficient planning and execution of their assigned program. Additionally, the successful candidate in this role would also be responsible for working closely with the Clinical Operations Team to support the development of clinical development processes, templates and potentially training and management of junior clinicalresearch scientists.
Job Responsibilities
Supports the clinical development of assigned programs and participates and supports the design and implementation of the development strategy
Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA)
The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience
May co-lead study team meetings in partnership with Clinical Operations study lead
Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums, act as primary point-of-contact for clinical study or program for clinical science related activities, and providing clinical science inputs into study safety reporting.
Clinical Scientists are likely to have regular external interactions with a variety of internal and external partners and stakeholders, such as cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups. They may also, alongside the Clinical Sciences Physician, participate in external interactions with health authorities (HAs)
Provides strategic clinical science support for assigned studies and programs
Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
May author and/or review clinical narratives in conjunction with pharmacovigilance
in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion in concert with Clinical Science Physicians
In concert with Clinical Sciences Physicians provide clinical contributions to internal documents and presentations including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts)
As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
Where applicable, may manage one or more direct reports and is, in such instances responsible for hiring, training, developing, and retaining talent on his/her staff.
As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
Core Competencies
Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally
Outstanding written communication skills
Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points
Comfortable working in fast paced entrepreneurial environment
Ability to travel up to 20%
Education and Experience
Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred)
Minimum of 5 years pharma/biotech industry experience in clinical development in oncology/hematology clinical trials
experience in CAR T-cell therapy is preferred
Experience in data review, data cleaning, managing and interpreting clinical trials results as well as exposure to writing protocols
Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinicalresearch
Physical Requirements
In office 4 days per week, required
Sedentary, desk position
Salary Range
$175,000-225,000 (final salary is dependent on candidate's experience and credentials)
$175k-225k yearly Auto-Apply 60d+ ago
Clinical Research Associate
Nymc
Clinical research associate job in Hawthorne, NY
Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinicalresearch nurses and team.
Responsibilities
Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols.
Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team.
Ensure compliance with the Good Clinical Practice guidelines in clinicalresearch.
Monitor study patients for adverse events in collaboration with clinical team and report as required.
Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements.
Qualifications
Education requirement: BS
Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments.
Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.
$48k-60k yearly Auto-Apply 60d+ ago
Clinical Research Scientist (EZIJP00002334)
Artech Information System 4.8
Clinical research associate job in Woodcliff Lake, NJ
Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications.
At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources.
Job Description
The incumbent is responsible for, but not limited to the following:
• Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
• Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, Client, Investigator Brochure, etc)
• Performs literature search and data analysis to address research questions
• In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
• Assisting in database cleaning, review of study results, and interpretation of results
• Adhering to key performance indicators for clinical study development, conduct, and reporting
• Individual contributor with specialized knowledge
• Presents concepts, facts, and reports and advises on key trends and issues
• Troubleshooting routine site inquiries
• Work is completed under limited supervision
• Supports the planning, execution and reporting of clinical programs/trials
• May handle multiple protocols simultaneously
• Contributes to risk resolution by escalating and monitoring project risks
• Minimum of 5-7 years of experience in clinicalresearch in the pharmaceutical industry
• A thorough understanding of clinicalresearch methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements
• Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred
• Knowledge of medical, scientific and clinicalresearch techniques in the oncology therapeutic area;
• Bachelor's Required. Doctoral (PharmD or PhD) degree preferred
Qualifications
BS/MS
Additional Information
For more information, Please contact
Best Regards,
Akriti Gupta
**************
Morristown, NJ 07960
$79k-116k yearly est. 1d ago
Clinical Research Scientist
Integrated Resources 4.5
Clinical research associate job in Woodcliff Lake, 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), ClinicalResearch, Rehabilitation Therapy and Nursing.
Job Description
Title: ClinicalResearch
Scientist
Duration: 12 Months (Possibility of Extension)
Location Woodcliff lake NJ
Job Responsibilities:
The incumbent is responsible for, but not limited to the following:
Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)
Performs literature search and data analysis to address research questions
In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
Assisting in database cleaning, review of study results, and interpretation of results
Adhering to key performance indicators for clinical study development, conduct, and reporting
Individual contributor with specialized knowledge
Presents concepts, facts, and reports and advises on key trends and issues
Troubleshooting routine site inquiries
Work is completed under limited supervision
Supports the planning, execution and reporting of clinical programs/trials
May handle multiple protocols simultaneously
Contributes to risk resolution by escalating and monitoring project risks
Qualifications
Qualifications
Minimum of
2-5 years of experience in clinicalresearch in the pharmaceutical industry
A thorough understanding of clinicalresearch methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements
Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred
Knowledge of medical, scientific and clinicalresearch techniques in the oncology therapeutic area;
Bachelor's Required. Doctoral (PharmD or PhD) or MD degree preferred
.
Additional Information
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus
Thank you for your time and consideration. I look forward to hearing from you!
Kind Regards
Ruchi Kumari
Clinical Recruiter
Integrated Resources
, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE
|
GSA - Schedule 66
I
GSA - Schedule 621I
(DIRECT BOARD) #
732-844-8716
(F) 732-549-5549
LinkedIn:
https://www.linkedin.com/in/ruchi-kumari
Gold Seal JCAHO Certified ™
for Health Care Staffing
“INC
5
0
0
0
's
FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
$77k-115k yearly est. 1d ago
Clinical Research Scientist
Mitsubishi Tanabe Pharma America 4.1
Clinical research associate job in Jersey City, NJ
Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's
oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Reporting to the Senior Director, Clinical Development, the ClinicalResearch Scientist will
provide
leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinicalresearch and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion.
The ClinicalResearch Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors.
He/she will provide clinicalresearch in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible.
Job Description
Prepare clinical-related documents with minimal supervision and routine documents independently as directed.
Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory
submissions such as INDs.
Author abstracts and manuscripts for publication in peer-reviewed journals.
Evaluate and select potential investigative sites in collaboration with Clinical Operations staff.
Ability to prepare, present and defend complex aspects of protocol design and/or study data at
investigator and internal meetings.
Oversee and coordinate the collection of and/or collect pre-study documents
Participate in data review and discrepancy resolution, team meetings/presentations with increasing
levels of independence and support the Program Clinical Leader or Sr. Management as needed.
Assist in managing regulatory safety reporting with the following: SAE queries and follow-up,
annual reports, investigator brochures, ability to learn various databases.
Critically review and synthesize complex information from reviews of the scientific and clinical
literature.
Qualifications
Minimum 2-5 years of pharmaceutical industry clinical trial experience.
Experience in immunology or endocrinology therapeutic areas is a plus.
Primary experience with development of clinical trial protocols.
Medical or scientific writing experience a must and familiarity with clinically applied science or
pharmaceutical development.
Good understanding of FDA regulatory, ICH, and GCP requirements.
Excellent communication skills, written and verbal.
Superior interpersonal communication and the ability to work across company disciplines and functional units.
Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
Attention to detail and a commitment to high quality and on-time deliverables are key success factors.
Willingness to travel up to 30% domestically and internationally.
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.
At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off
$75k-125k yearly est. 1d ago
Clinical Research Scientist
Lancesoft 4.5
Clinical research associate job in Woodcliff Lake, NJ
Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits.
I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization.
Job Description
Description
The incumbent is responsible for, but not limited to the following:
• Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
• Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)
• Performs literature search and data analysis to address research questions
• In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
• Assisting in database cleaning, review of study results, and interpretation of results
• Adhering to key performance indicators for clinical study development, conduct, and reporting
• Individual contributor with specialized knowledge
• Presents concepts, facts, and reports and advises on key trends and issues
• Troubleshooting routine site inquiries
• Work is completed under limited supervision
• Supports the planning, execution and reporting of clinical programs/trials
• May handle multiple protocols simultaneously
• Contributes to risk resolution by escalating and monitoring project risks
• Minimum of 5-7 years of experience in clinicalresearch in the pharmaceutical industry
• A thorough understanding of clinicalresearch methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements
• Working knowledge of the IND/NDA/ CTD/ MAA process acquired through direct industrial experience preferred
• Knowledge of medical, scientific and clinicalresearch techniques in the oncology therapeutic area;
• Bachelor's Required. Doctoral (PharmD or PhD) degree preferred
Qualifications
Bachelor's Required. Doctoral (PharmD or PhD) degree preferred
Minimum of 5-7 years of experience in clinicalresearch in the pharmaceutical industry
Additional Information
All your information will be kept confidential according to EEO guidelines.
$78k-121k yearly est. 1d ago
Clinical Study Coordinator/Specialist
Henkel 4.7
Clinical research associate job in Stamford, CT
Consumer BrandsResearch & DevelopmentUnited States, Stamford, CT, CTFull TimeRegular **_About_** **_this_** **_position_** At Henkel, you'll be part of an organization that's shaping the future through innovation, sustainability and collaboration. With our trusted brands like Persil , 'all , Loctite , Snuggle , and Schwarzkopf and our cutting-edge technologies, you'll have countless opportunities to explore new paths and grow.
This position is with our Consumer Brands business unit - where we empower our employees to bring the best Laundry & Home Care and Hair products to people around the world.
_Henkel's R&D labs are planned to relocate to Trumbull, CT in the latter half of 2027. This position will move with the team. Candidates pursuing this opportunity will be working on-site at our Trumbull R&D center once the relocation is complete._
**Dare to learn new skills, advance in your career and make an impact at Henkel. **
**What you´ll do**
Business Context
+ Henkel CTI team (Consumer Technology & Insights) is looking for its new Clinical Study Coordinator to execute clinical studies for claims support and development of new products. If you are interested in supporting R&D needs with strong clinical data and outstanding innovations, then join our CTI community and be a key contributor at Henkel HCB!
Main Purpose of the Job
+ Steer and coordinate clinical studies to strengthen claims support for the HCB NA R&D Team.
Duties and Tasks
+ With the support of the Clinicals manager:
+ Executes well designed clinical studies per written protocols.
+ Interprets study results and recommends next steps, as necessary.
+ Provides topline results and final reports to study sponsors.
+ Ensures accurate data is generated during the conduct of the study.
+ Ensures test instruments are properly maintained and calibrated per standard operating procedures.
+ Highly customer oriented, interact daily with clinical study subjects. Conduct 1 on 1 interviews, collect medical history information, take vitals and apply beauty care products.
**What makes you a good fit**
Skills
+ Knowledge of Good Clinical Practices (GCP), Clinical Coordinator certification preferred
+ Consistently produces dependable and highly reliable results independently, thorough understanding of clinical test methods and interpretation of results
+ Ability to work in fluid environment, positive interactions with study subjects, that demands creativity with new product test methods
+ Good communication skills with product development, clinical subjects, etc, and desire to work in a team environment
+ Assists in clinical study subject recruitment and maintenance of recruiting database
Minimum Qualifications:
+ Education - Minimum of a B.S. degree and experience in study design and the conduct of clinical trials is preferred.
+ Experience - 1-3 years of relevant laboratory and industry experience
+ Skills - Consumer product R&D experience preferred, problem solving skills, communication and analytical skills, quick learner, strong interpersonal skills
+ Certifications and licenses -Certified Clinical Coordinator would be a plus but not required
+ Physical Requirements: The physical requirements of this job are consistent with an office job: significant amount of time at a computer station. On rare occasions there is a need to lift up to 20 pounds.
**Some benefits of joining Henkel**
+ **Health Insurance:** affordable plans for medical, dental, vision and wellbeing starting on day 1
+ **Work-Life Balance:** Paid time off including sick, vacation, holiday and volunteer time, flexible & hybrid work policies (depending on role), and vacation buy / sell program
+ **Financial:** 401k matching, employee share plan with voluntary investment and Henkel matching shares, annual performance bonus, service awards and student loan reimbursement
+ **Family Support:** 12-week gender neutral parental leave (up to 20 weeks for parents giving birth), fertility support, adoption & surrogacy reimbursement, discounted child and elderly care, and scholarships
+ **Career Growth:** diverse national and international growth opportunities, access to thousands of skills development courses, and tuition reimbursement
The salary for this role is $70,000.00 - $80,000.00. This is the range that we in good faith anticipate relying on when setting wages for this position. We may ultimately pay more or less than the posted range and this range. This salary range may also be modified in the future.
Henkel does not accept unsolicited resumes from search firms or employment agencies. Unsolicited referrals and resumes are considered Henkel property and therefore, Henkel will not pay a fee for any placement resulting from the receipt of an unsolicited referral.
Henkel is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information, and other legally protected categories.
**JOB ID:** 25089848
**Job Locations:** United States, CT, Stamford, CT
**Contact information for application-related questions:** *****************************
Please do not use this email address for sending your application or CV. To apply, please click on the "Apply for this role" button below. Applications sent via e-mail will not be accepted.
**Application Deadline:** As long as the vacancy is listed on our Career Site, we are happy to receive your application
**Job-Center:** If you have an application already, you can create or log in to your accounthere (******************************************************************************************************************************************************** to check the status of your application. In case of new account creation, please use your email address that you applied with.
$70k-80k yearly Easy Apply 39d ago
Study participant - US (EST)
Prolific 4.2
Clinical research associate job in New York, NY
Study Participants
Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world.
Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills.
The role
We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects.
Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter.
What you'll bring
A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable)
A willingness to take our screening to assess your suitability for our participant pool
Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time
A reliable and fast internet connection and access to a computer
A willingness to self-declare your earnings, as our participants are self-employed
A Paypal account to receive payment from our clients
What you'll be doing in the role
Completing paid research studies such as answering surveys, participating in experiments, and providing written responses
Providing feedback, judgements, and opinions in structured research tasks
Contributing to high-quality research outcomes by responding thoughtfully and accurately
Key study types
Surveys and Questionnaires
Behavioural Experiments
User Research and Product Feedback
Educational and Academic Studies
Interviews and Open-Ended Responses
Quality Checks and Attention Tasks
Why Prolific is a great platform to join as a Participant
Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home.
We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines.
We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity.
Links to more information on Prolific
Website
Youtube
Privacy Statement
By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.
$18 hourly Auto-Apply 19d ago
Clinical Research Associate
Allen Spolden
Clinical research associate job in West New York, NJ
Responsible for providing ClinicalResearch support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinicalresearch functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
3+ years of clinicalresearch experience
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
$53k-83k yearly est. 60d+ ago
Clinical Research Scientist (EZIJP00002334)
Artech Information System 4.8
Clinical research associate job in Woodcliff Lake, NJ
Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications.
At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources.
Job Description
The incumbent is responsible for, but not limited to the following:
• Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
• Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, Client, Investigator Brochure, etc)
• Performs literature search and data analysis to address research questions
• In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
• Assisting in database cleaning, review of study results, and interpretation of results
• Adhering to key performance indicators for clinical study development, conduct, and reporting
• Individual contributor with specialized knowledge
• Presents concepts, facts, and reports and advises on key trends and issues
• Troubleshooting routine site inquiries
• Work is completed under limited supervision
• Supports the planning, execution and reporting of clinical programs/trials
• May handle multiple protocols simultaneously
• Contributes to risk resolution by escalating and monitoring project risks
• Minimum of 5-7 years of experience in clinicalresearch in the pharmaceutical industry
• A thorough understanding of clinicalresearch methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements
• Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred
• Knowledge of medical, scientific and clinicalresearch techniques in the oncology therapeutic area;
• Bachelor's Required. Doctoral (PharmD or PhD) degree preferred
Qualifications
BS/MS
Additional Information
For more information, Please contact
Best Regards,
Akriti Gupta
**************
Morristown, NJ 07960
$79k-116k yearly est. 60d+ ago
Clinical Research Scientist
Integrated Resources 4.5
Clinical research associate job in Woodcliff Lake, 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), ClinicalResearch, Rehabilitation Therapy and Nursing.
Job Description
Title: ClinicalResearch Scientist
Duration: 12 Months (Possibility of Extension)
Location Woodcliff lake NJ
Job Responsibilities:
The incumbent is responsible for, but not limited to the following:
Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)
Performs literature search and data analysis to address research questions
In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
Assisting in database cleaning, review of study results, and interpretation of results
Adhering to key performance indicators for clinical study development, conduct, and reporting
Individual contributor with specialized knowledge
Presents concepts, facts, and reports and advises on key trends and issues
Troubleshooting routine site inquiries
Work is completed under limited supervision
Supports the planning, execution and reporting of clinical programs/trials
May handle multiple protocols simultaneously
Contributes to risk resolution by escalating and monitoring project risks
Qualifications
Qualifications
Minimum of 2-5 years of experience in clinicalresearch in the pharmaceutical industry
A thorough understanding of clinicalresearch methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements
Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred
Knowledge of medical, scientific and clinicalresearch techniques in the oncology therapeutic area;
Bachelor's Required. Doctoral (PharmD or PhD) or MD degree preferred.
Additional Information
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus
Thank you for your time and consideration. I look forward to hearing from you!
Kind Regards
Ruchi Kumari
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
(DIRECT BOARD) # 732-844-8716 (F) 732-549-5549
LinkedIn: https://www.linkedin.com/in/ruchi-kumari
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
$77k-115k yearly est. 60d+ ago
Clinical Research Scientist
Mitsubishi Tanabe Pharma America 4.1
Clinical research associate job in Jersey City, NJ
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's
oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Reporting to the Senior Director, Clinical Development, the ClinicalResearch Scientist will provide
leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinicalresearch and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion.
The ClinicalResearch Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinicalresearch in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible.
Job Description
Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory
submissions such as INDs.
Author abstracts and manuscripts for publication in peer-reviewed journals.
Evaluate and select potential investigative sites in collaboration with Clinical Operations staff.
Ability to prepare, present and defend complex aspects of protocol design and/or study data at
investigator and internal meetings.
Oversee and coordinate the collection of and/or collect pre-study documents
Participate in data review and discrepancy resolution, team meetings/presentations with increasing
levels of independence and support the Program Clinical Leader or Sr. Management as needed.
Assist in managing regulatory safety reporting with the following: SAE queries and follow-up,
annual reports, investigator brochures, ability to learn various databases.
Critically review and synthesize complex information from reviews of the scientific and clinical
literature.
Qualifications
Minimum 2-5 years of pharmaceutical industry clinical trial experience.
Experience in immunology or endocrinology therapeutic areas is a plus.
Primary experience with development of clinical trial protocols.
Medical or scientific writing experience a must and familiarity with clinically applied science or
pharmaceutical development.
Good understanding of FDA regulatory, ICH, and GCP requirements.
Excellent communication skills, written and verbal.
Superior interpersonal communication and the ability to work across company disciplines and functional units.
Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
Attention to detail and a commitment to high quality and on-time deliverables are key success factors.
Willingness to travel up to 30% domestically and internationally.
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off
$75k-125k yearly est. 60d+ ago
Clinical Research Scientist
Lancesoft 4.5
Clinical research associate job in Woodcliff Lake, NJ
Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits.
I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization.
Job Description
Description
The incumbent is responsible for, but not limited to the following:
• Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
• Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)
• Performs literature search and data analysis to address research questions
• In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
• Assisting in database cleaning, review of study results, and interpretation of results
• Adhering to key performance indicators for clinical study development, conduct, and reporting
• Individual contributor with specialized knowledge
• Presents concepts, facts, and reports and advises on key trends and issues
• Troubleshooting routine site inquiries
• Work is completed under limited supervision
• Supports the planning, execution and reporting of clinical programs/trials
• May handle multiple protocols simultaneously
• Contributes to risk resolution by escalating and monitoring project risks
• Minimum of 5-7 years of experience in clinicalresearch in the pharmaceutical industry
• A thorough understanding of clinicalresearch methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements
• Working knowledge of the IND/NDA/ CTD/ MAA process acquired through direct industrial experience preferred
• Knowledge of medical, scientific and clinicalresearch techniques in the oncology therapeutic area;
• Bachelor's Required. Doctoral (PharmD or PhD) degree preferred
Qualifications
Bachelor's Required. Doctoral (PharmD or PhD) degree preferred
Minimum of 5-7 years of experience in clinicalresearch in the pharmaceutical industry
Additional Information
All your information will be kept confidential according to EEO guidelines.
$78k-121k yearly est. 60d+ ago
Clinical Study Coordinator/Specialist
Henkel 4.7
Clinical research associate job in Stamford, CT
At Henkel, you'll be part of an organization that's shaping the future through innovation, sustainability and collaboration. With our trusted brands like Persil, 'all, Loctite, Snuggle, and Schwarzkopf and our cutting-edge technologies, you'll have countless opportunities to explore new paths and grow.
This position is with our Consumer Brands business unit - where we empower our employees to bring the best Laundry & Home Care and Hair products to people around the world.
Henkel's R&D labs are planned to relocate to Trumbull, CT in the latter half of 2027. This position will move with the team. Candidates pursuing this opportunity will be working on-site at our Trumbull R&D center once the relocation is complete.
Dare to learn new skills, advance in your career and make an impact at Henkel.
What you´ll do
Business Context
* Henkel CTI team (Consumer Technology & Insights) is looking for its new Clinical Study Coordinator to execute clinical studies for claims support and development of new products. If you are interested in supporting R&D needs with strong clinical data and outstanding innovations, then join our CTI community and be a key contributor at Henkel HCB!
Main Purpose of the Job
* Steer and coordinate clinical studies to strengthen claims support for the HCB NA R&D Team.
Duties and Tasks
* With the support of the Clinicals manager:
* Executes well designed clinical studies per written protocols.
* Interprets study results and recommends next steps, as necessary.
* Provides topline results and final reports to study sponsors.
* Ensures accurate data is generated during the conduct of the study.
* Ensures test instruments are properly maintained and calibrated per standard operating procedures.
* Highly customer oriented, interact daily with clinical study subjects. Conduct 1 on 1 interviews, collect medical history information, take vitals and apply beauty care products.
What makes you a good fit
Skills
* Knowledge of Good Clinical Practices (GCP), Clinical Coordinator certification preferred
* Consistently produces dependable and highly reliable results independently, thorough understanding of clinical test methods and interpretation of results
* Ability to work in fluid environment, positive interactions with study subjects, that demands creativity with new product test methods
* Good communication skills with product development, clinical subjects, etc, and desire to work in a team environment
* Assists in clinical study subject recruitment and maintenance of recruiting database
Minimum Qualifications:
* Education - Minimum of a B.S. degree and experience in study design and the conduct of clinical trials is preferred.
* Experience - 1-3 years of relevant laboratory and industry experience
* Skills - Consumer product R&D experience preferred, problem solving skills, communication and analytical skills, quick learner, strong interpersonal skills
* Certifications and licenses -Certified Clinical Coordinator would be a plus but not required
* Physical Requirements: The physical requirements of this job are consistent with an office job: significant amount of time at a computer station. On rare occasions there is a need to lift up to 20 pounds.
Some benefits of joining Henkel
* Health Insurance: affordable plans for medical, dental, vision and wellbeing starting on day 1
* Work-Life Balance: Paid time off including sick, vacation, holiday and volunteer time, flexible & hybrid work policies (depending on role), and vacation buy / sell program
* Financial: 401k matching, employee share plan with voluntary investment and Henkel matching shares, annual performance bonus, service awards and student loan reimbursement
* Family Support: 12-week gender neutral parental leave (up to 20 weeks for parents giving birth), fertility support, adoption & surrogacy reimbursement, discounted child and elderly care, and scholarships
* Career Growth: diverse national and international growth opportunities, access to thousands of skills development courses, and tuition reimbursement
The salary for this role is $70,000.00 - $80,000.00. This is the range that we in good faith anticipate relying on when setting wages for this position. We may ultimately pay more or less than the posted range and this range. This salary range may also be modified in the future.
Henkel does not accept unsolicited resumes from search firms or employment agencies. Unsolicited referrals and resumes are considered Henkel property and therefore, Henkel will not pay a fee for any placement resulting from the receipt of an unsolicited referral.
Henkel is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information, and other legally protected categories.
JOB ID: 25089848
Job Locations: United States, CT, Stamford, CT
Contact information for application-related questions: *****************************
Please do not use this email address for sending your application or CV. To apply, please click on the "Apply for this role" button below. Applications sent via e-mail will not be accepted.
Application Deadline: As long as the vacancy is listed on our Career Site, we are happy to receive your application
Job-Center: If you have an application already, you can create or log in to your account here to check the status of your application. In case of new account creation, please use your email address that you applied with.
Activate external content
When clicking the button below external content will be loaded which involves transfer of personal data (e.g. IP address) to external servers. This may involve that cookies are set by the external content provider. Please see Data Protection Statement for further information.
Accept for all YouTube content
LOAD EXTERNAL CONTENT
Deactivate loading external content from YouTube.
How is work at Henkel
About Henkel
Building on a strong legacy of almost 150 years, we are leading the way to reimagine and improve life every day. Today and for generations to come. Through our innovative and sustainable brands and technologies, across our teams around the world.
Henkel holds leading positions in both industrial and consumer businesses: Our portfolio includes well-known hair care products, laundry detergents, fabric softeners as well as adhesives, sealants, and functional coatings.
How much does a clinical research associate earn in North Hempstead, NY?
The average clinical research associate in North Hempstead, NY earns between $44,000 and $101,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.
Average clinical research associate salary in North Hempstead, NY