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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
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Clinical Research Coordinator
Actalent
Clinical research associate job in New York, NY
ClinicalResearch Coordinator -Oncology
On-site 4 days per week
ClinicalResearch Coordinator
This role is critical in supporting Oncology clinical trials from initiation through completion, ensuring compliance with regulatory standards and delivering high-quality data
Key Responsibilities
Coordinate initiation and activation of new clinical trial protocols
Prepare study tools (binders, medication diaries, eligibility checklists, flow sheets) using OnCore, Excel, and Word
Review patient charts and medical history to confirm protocol eligibility; obtain and maintain source documentation
Ensure informed consent is obtained, documented, and filed per IRB guidelines
Maintain accurate research records, including consent forms, eligibility documentation, CRFs, and source documents
Assist with grading adverse events using NCI toxicity criteria; complete SAE forms per sponsor and regulatory requirements
Generate regular reports for tumor study groups and Principal Investigators using OnCore
Serve as liaison with study sponsors; schedule monitoring visits and respond to queries promptly
Perform blood processing as required for clinical trial protocols
Qualifications
Bachelor's degree required
2+ years of clinicalresearch experience (patient recruitment, data collection, data entry)
2+ years of oncology experience
Experience in data management
Experience recruiting, screening, and consenting patients for clinical trials
Proficiency in multiple EDC systems (Medidata and Inform highly preferred)
Familiarity with OnCore and Microsoft Office Suite
Blood processing experience
Job Type & Location
This is a Contract to Hire position based out of Bronx, NY.
Pay and Benefits
The pay range for this position is $30.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Bronx,NY.
Application Deadline
This position is anticipated to close on Jan 27, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$30-35 hourly 6d ago
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:
â—Ź Develop lesson plans according to the various learning styles of program participants.
â—Ź Facilitate groups with the goal of improving literacy skills.
â—Ź Identify ways to connect classroom learning with real-world applications, ensuring that participants understand how to apply skills in workplace environments.
â—Ź Coordinate with program staff to ensure that participants' progress is being appropriately tracked and supported.
â—Ź 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.
â—Ź Provide necessary accommodations and modifications for the growth and success of all students.
â—Ź Attend professional development workshops and learning communities that will discuss RLA and Social Studies subtests, as well as curriculum development for the GED exam.
â—Ź Administer and utilize standardized assessments to develop curricula targeting the educational challenges of the students.
â—Ź Monitor students' performance and attendance for required reporting systems.
â—Ź Assist in the evaluation of participant engagement and curriculum effectiveness.
â—Ź Collaborate with case managers and program leads to ensure participants' holistic success in the program.
â—Ź Maintain flexibility to support program and agency-wide goals as needed
â—Ź Implement strategies to maximize student retention.
QUALIFICATIONS & REQUIREMENTS:
Required & Preferred Qualifications
â—Ź Bachelor's Degree in Education or comparable field required.
â—Ź Minimum of two years of experience overseeing young adult learners of varied ages, levels, and diverse cultural backgrounds.
â—Ź Knowledge of ABE and GED curricula, testing procedures, and requirements.
â—Ź Demonstrated ability in youth development
WORKING CONDITIONS
â—Ź Participation in all staff meetings and staff training seminars.
â—Ź Participation in agency-wide programs and program committees, as assigned.
â—Ź Active involvement as a supervisee in the supervision process.
â—Ź Support the mission of Commonpoint.
â—Ź 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 - 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
$39k-57k yearly est. 18h 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
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 1
Allen Spolden
Clinical research associate job in New York, NY
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, PTO 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 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
Oncology CRA/Clinical Site Monitor (field-based) - NY/NJ
Astellas Pharma 4.9
Clinical research associate job in Jersey City, NJ
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
This field-based position is based in either New York or New Jersey.
Purpose and Scope:
A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.
Responsibilities may include assisting with or primary responsibility for:
Site Selection
Pre-trial assessment
Site level Study Participant recruitment/retention plans
Site Activation/Initiation
On-site and remote monitoring
Overall site relationship management in collaboration with other sponsor roles that interact with the site
Close-out activities
Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role.
Responsibilities & Accountabilities:
Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
Develops meaningful site relationships through consistent collaborative communication and engagement.
May participate in site feasibility and/or pre-trial site assessment visits.
Attends/participates in investigator meetings as needed.
May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
Ensures site non-IMP study supplies are adequate for trial conduct.
Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
Oversees the appropriate destruction of clinical supplies.
Ensures site staff complete data entry and resolve queries within expected timelines.
Ensures validity and completeness of data collected at trial sites.
Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
Prepares trial sites for close out, conduct final close out visit.
Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.
$67k-110k yearly est. 14h ago
Clinic Trials Support Specialist
Maimonides Medical Center 4.7
Clinical research associate job in New York, NY
About Us We're Maimonides Health, Brooklyn's largest healthcare system, serving over 250,000 patients each year through the system's 3 hospitals, 1800 physicians and healthcare professionals, more than 80 community-based practices and outpatient centers. At Maimonides Health, our core values H.E.A.R.T drives everything we do. We uphold and maintain Honesty, Empathy, Accountability, Respect, and Teamwork to empower our talented team, engage our respective communities and adhere to Planetree's philosophy of patient-centered care. The system is anchored by Maimonides Medical Center, one of the nation's largest independent teaching hospitals and home to centers of excellence in numerous specialties; Maimonides Midwood Community Hospital (formerly New York Community Hospital), a 130-bed adult medical-surgical hospital; and Maimonides Children's Hospital, Brooklyn's only children's hospital and only pediatric trauma center. Maimonides' clincal progams rank among the best in the country for patient outcomes, including its Heart and Vascular Institute, Neuroscience Institute, Boneand Joint Center, and Cancer Center. Maimonides is an affiliate of Northwell Health and a major clinical training site for SUNY Downstate College of Medicine.
Overview
The Clinic Trials Support Specialist responsible for coordinating and supporting the conduct of clinicalresearch protocols and projects, with a primary focus on screening, enrolling, and monitoring patient participants. This role works closely with investigators, clinical teams, and research staff to ensure studies are conducted in accordance with approved protocols, regulatory requirements, and institutional policies while maintaining participant safety and data integrity.
Responsibilities
* Prepare, submit, and maintain IRB and regulatory documentation, including Trial Master File, delegation logs, regulatory binders, and essential study files
* Screen, enroll, and consent participants in collaboration with the Principal Investigator, ensuring proper informed consent documentation
* Educate study participants on protocol requirements and support completion of required study procedures and surveys
* Coordinate participant visits, tests, and procedures; assist physicians during patient visits in accordance with study protocols
* Monitor subject recruitment and study progress, report adverse events in RAVE following discussion with the Principal Investigator
* Collect, process, and ship research specimens per protocol and IATA/DOT standards; manage study kit inventory, shipments, and data collection from electronic medical records, including timely database submission and query resolution
Qualifications
We require:
* Bachelors of Science in Biology or Chemistry; Masters preferred.
* 2+ years of research experience in the medical field or an advanced degree in a Biology or Chemistry required.
* Good oral and written communication skills.
* Good interpersonal and organizational skills.
* Speaks, reads and writes English to the extent required by the position.
* Ability to speak Chinese or Mandarin is a plus.
Pay Range
USD $66,779.00 - USD $66,779.00 /Yr.
Equal Employment Opportunity Employer
Maimonides Medical Center (MMC) is an equal opportunity employer.
$66.8k yearly 14d 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 40d ago
Travel Clinical Research Coordinator
Care Access 4.3
Clinical research associate job in New York, NY
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinicalresearch and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes A Difference The Travel ClinicalResearch Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinicalresearch study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinicalresearch process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access to the community, Sponsors, CROs, and study participants and their family members. The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinicalresearch coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinicalresearch industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations. How You'll Make An Impact
Study Preparation:
Ability to understand and follow institutional SOPs
Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct
Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff
Assist with planning and creation of appropriate recruitment and marketing materials
Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc.
Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives
Assist in the creation or review of protocol specific source documents
Determine facility, equipment and outsource vendor requirements and availability
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance
Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks
Study Management:
Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety.
Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies
Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records
Collect and evaluate concomitant medications
Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual.
Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access team in an ongoing fashion
Maintain effective relationships with study participants and other Care Access personnel
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management
Strong and clear communication skills, both verbally and in writing
Accept accountability for actions and function independently
Patient Coordination:
Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
Obtain informed consent per Care Access SOP and document process when revised ICF discussed with patient during course of the trial
Administer delegated study questionnaires, where appropriate.
Collect and evaluate medical records with the support of medically qualified members of the study team.
Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol
Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs)
Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround
Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.
Monitor patient progress on study medication
Documentation:
Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion.
Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
Accurately transcribe data to CRF or EDC.
Resolve data management queries and correct source data as needed
Record protocol exemptions and deviations as appropriate with sponsor.
Complete Note(s)-to-File for patient chart and regulatory filing if necessary
Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing
Maintain copies of patient-specific correspondence in source charts
Assist regulatory personnel with completion of continuing/final review reports
Perform other duties as assigned.
The Expertise Required
Excellent working knowledge of clinical trials, medicine and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+
Ability to communicate and work effectively with a diverse team of professionals
Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel.
Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc.
Critical thinker and problem solver
Friendly, outgoing personality; maintain a positive attitude under pressure
High level of self-motivation and energy
Excellent professional writing and communication skills
Ability to work independently in a fast-paced environment with minimal supervision
Certifications/Licenses, Education, and Experience:
BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred
RN or LPN preferred
Research Professional Certification- CRCC or exam eligibility preferred
A minimum of 3 to 4 years ClinicalResearch experience
A minimum of 2 years prior ClinicalResearch Coordinator experience, management level preferred.
How We Work Together
Travel: Extensive travel required. Candidates must be willing to travel 75% of the time nationwide.
Duties may require travel for a two-week stretch, followed by one week home.
Frequency and length of travel may depend on the length and location of study.
The expected salary range for this role is $70,000 - $100,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
$70k-100k yearly Auto-Apply 12d 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 Coordinator (Sample Management)
Actalent
Clinical research associate job in New York, NY
ClinicalResearch Coordinator -Oncology
On-site 4 days per week
ClinicalResearch Coordinator
This role is critical in supporting Oncology clinical trials from initiation through completion, ensuring compliance with regulatory standards and delivering high-quality data. Helping with managing research protocols involving tissue specimens. review research protocols for feasibility and ensure alignment with institutional capabilities, specimen availability and regulatory requirements.
Key Responsibilities
Collaborate with principal investigators, pathologists, and lab personnel to identify and procure appropriate specimens for translational and retrospective studies. Coordinate initiation and activation of new clinical trial protocols
Support workflow improvements by identifying operational inefficiencies and developing solutions to streamline specimen processing, tracking, and data capture.
Assist with grading adverse events using NCI toxicity criteria; complete SAE forms per sponsor and regulatory requirements
Generate regular reports for tumor study groups and Principal Investigators using OnCore
Serve as liaison with study sponsors; schedule monitoring visits and respond to queries promptly
Perform blood processing as required for clinical trial protocols
Qualifications
Bachelor's degree required
2+ years of clinicalresearch experience (patient recruitment, data collection, data entry)
Specimen Processing experience
Oncology Experience
Experience recruiting, screening, and consenting patients for clinical trials
Proficiency in multiple EDC systems (Medidata and Inform highly preferred)
Familiarity with OnCore and Microsoft Office Suite
Blood processing experience
Job Type & Location
This is a Contract to Hire position based out of bronx, NY.
Pay and Benefits
The pay range for this position is $30.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in bronx,NY.
Application Deadline
This position is anticipated to close on Feb 2, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$30-35 hourly 5d 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
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
Oncology CRA/Clinical Site Monitor (field-based) - NY/NJ
Astellas Pharma, Inc. 4.9
Clinical research associate job in Jersey City, NJ
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
This field-based position is based in either New York or New Jersey.
Purpose and Scope:
A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.
Responsibilities may include assisting with or primary responsibility for:
* Site Selection
* Pre-trial assessment
* Site level Study Participant recruitment/retention plans
* Site Activation/Initiation
* On-site and remote monitoring
* Overall site relationship management in collaboration with other sponsor roles that interact with the site
* Close-out activities
Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role.
Responsibilities & Accountabilities:
* Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
* Develops meaningful site relationships through consistent collaborative communication and engagement.
* May participate in site feasibility and/or pre-trial site assessment visits.
* Attends/participates in investigator meetings as needed.
* May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
* Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
* Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
* Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
* Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
* Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
* Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
* Ensures site non-IMP study supplies are adequate for trial conduct.
* Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
* Oversees the appropriate destruction of clinical supplies.
* Ensures site staff complete data entry and resolve queries within expected timelines.
* Ensures validity and completeness of data collected at trial sites.
* Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
* Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
* Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
* Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
* Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
* Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
* Prepares trial sites for close out, conduct final close out visit.
* Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
* May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
* May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.
$67k-110k yearly est. 14d 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.
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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.
$70k-80k yearly Easy Apply 26d ago
Clinical Research Coordinator I (Yonkers, NY)
Care Access 4.3
Clinical research associate job in Yonkers, NY
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinicalresearch and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The ClinicalResearch Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinicalresearch study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
Patient Coordination
Prescreen study candidates
Obtain informed consent per Care Access Research SOP.
Complete visit procedures in accordance with protocol.
Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Documentation
Record data legibly and enter in real time on paper or e-source documents
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data management queries and correct source data within sponsor provided timelines.
Assist regulatory personnel with completion and filing of regulatory documents.
Assist in the creation and review of source documents.
Patient Recruitment
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects
Other Responsibilities
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct.
Communicate clearly verbally and in writing.
Attend Investigator meetings as required.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
Maintain effective relationships with study participants and other care Access Research personnel.
The Expertise Required
Ability to understand and follow institutional SOPs.
Excellent working knowledge of medical and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP)
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
Critical thinker and problem solver
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self-motivation and energy
Excellent professional writing and communication skills
Ability to work independently in a fast-paced environment with minimal supervision.
Certifications/Licenses, Education, and Experience:
Bachelor's Degree preferred, or equivalent combination of education, training and experience.
A minimum of 1-year prior ClinicalResearch Coordinator experience required
Recent phlebotomy experience required
How We Work Together
Location: Position requires onsite work 5 days per week at the Yonkers, NY or Hoboken, NJ clinic.
Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives.
Physical demands associated with this position Include:
Walking-20%
Standing-20%
Sitting-20%
Lifting-20%
Up to 25lbs Overhead
Driving-20%
The expected salary range for this role is $55,000 - $85,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
How much does a clinical research associate earn in Babylon, NY?
The average clinical research associate in Babylon, NY earns between $44,000 and $102,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.
Average clinical research associate salary in Babylon, NY