Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Trial Associates (CTA). This role will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents, assisting with study start-up, conduct and close-out of study activities. This individual will have accountability for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF).
Key Responsibilities
* Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation.
* Set up and maintain study-specific paper and electronic TMFs.
* Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices.
* Track and report CRO's ability to maintain TMF health metrics on an ongoing basis.
* Process essential documents and ensure they are correctly filed in the appropriate TMF.
* Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed.
* Participate in GxP audits and related clinical operations compliance and inspection readiness activities.
* Prepare and track study documents (e.g., contracts, budgets, IRB documentation).
* Assist with information gathering, literature searches, and creation of presentations, as needed.
* Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.)
* Administer user access and change control within Anavex's electronic systems.
* Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems.
* Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards.
* Assist with vendor management and associated logistics, as assigned.
* Contribute to the creation of presentations, as needed for project, departmental, sponsor, and/or business development presentations.
* Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies.
* Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel)
* Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual.
* Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management.
* Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF.
* Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
* Assist in creating and implementing departmental SOPs and procedures.
The position will be filled at a level commensurate with experience.
Requirements
* BS/BA in Life Sciences or equivalent
* 3+ years of experience in similar positions in Biotech, Pharmaceutical, or clinicalresearch organization environment
* Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC/ QR, and query management.
* Familiar with the DIA reference model
* Knowledge of ICH/GCP and applicable regulations
* Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence the decision-making of managers, and working partners (local and global)
* Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining a high attention to detail and responding to rapidly changing priorities and aggressive deadlines
* Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox
* Strong critical thinking, organizational and time-management skills
* Ability and willingness to travel (up to 10% of the time)
$79k-131k yearly est. 6d ago
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Clinical Research Director, Immunology & Inflammation (Rheumatology)
Sanofi 4.3
Clinical research associate job in Morristown, NJ
The ClinicalResearch Director in Immunology & Inflammation (Rheumatology) leads clinical development strategies and coordinates cross-functional teams to advance therapies for autoimmune and inflammatory diseases. This role involves designing clinical trials, ensuring regulatory compliance, engaging with health authorities, and collaborating with external experts to progress drug discovery and development. The director contributes scientific expertise, facilitates study execution, and represents the company at scientific and regulatory forums.
Job title: ClinicalResearch Director in Immunology & Inflammation (Rheumatology)
Location: Cambridge, MA / Morristown, NJ
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Position Overview:
The ClinicalResearch Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in rheumatologic diseases, incorporate new methodologies, and pro-actively progress study execution. The role will focus on developing innovative therapies for autoimmune and inflammatory diseases, with a particular emphasis on rheumatology.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Create clinical development strategy and plans for one or more assets
Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies
Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
Advance the clinical development plan through internal management review
Lead a clinical sub team to design clinical studies and to create study protocols
Execute the clinical development plan in close collaboration with clinical operations
Advance scientific and clinical knowledge for immunology in rheumatologic diseases
Incorporate new trial, scientific and digital methodologies
Pro-actively progress study execution
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval
Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews)
Serve as a medical expert and provide strategic input to early-stage programs
Collaborate with external experts, key opinion leaders, and investigators to advance clinicalresearch
Represent Sanofi at scientific conferences and regulatory meetings
About You
Experience / Skills:
MD or MD/PhD in a relevant scientific discipline with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization
Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia)
Have experience in novel approaches to translational medicine
Have and maintain deep scientific, technical and clinical knowledge in immunologic/rheumatologic diseases
Expertise in autoimmune and inflammatory diseases, particularly in rheumatology
Demonstrate problem solving skills
Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area
Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment
Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences
Proven track record of scientific publications and presentations at international conferences
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Keywords:
clinicalresearch director, immunology, rheumatology, inflammation, clinical development, pharmaceutical industry, drug discovery, clinical trials, regulatory compliance, autoimmune diseases
$74k-117k yearly est. 6d ago
Clinical Trial Specialist
Actalent
Clinical research associate job in Newark, NJ
We are seeking a dedicated Clinical Trial Specialist to join our team, focusing on protocol activation and study accrual. This role involves collaborating with various departments to initiate and activate new clinical trial protocols, ensuring compliance with regulatory requirements, and providing high-quality patient care. The successful candidate will facilitate communication between patients and research teams, manage protocol-specific orders, and ensure adherence to study guidelines.
Responsibilities
Collaborate with the Protocol Activation office to initiate and activate new clinical trial protocols, utilizing study-start up task lists.
Prepare and review study tools, including study binders, medication diaries, eligibility checklists, and flow sheets.
Verify Scientific Review Board (SRB), Institutional Review Board (IRB), data collection plans, and finance/contract approvals prior to study activation.
Conduct protocol-related nursing education to facilitate safe, effective care of enrolled patients.
Translate finalized protocol treatment plans, study calendars, and clinical trials billing grids into sample orders.
Coordinate with the clinicalresearch team for timely prescreening of potential subjects and active cancer patients for available clinical trials.
Review patient charts and medical history to confirm protocol eligibility and obtain source documents as needed.
Ensure informed consent processes are followed, and consent is obtained, signed, and documented in medical records.
Provide back-up support for registering consented research patients with study sponsors and input data into the clinical trials database.
Serve as a resource for Clinical Trial Billing Information related to assigned studies.
Act as a link between patients and research team members, addressing and communicating challenges in protocol procedures.
Ensure accurate execution of protocol-specific orders, scheduling, and completion of tests and appointments.
Coordinate protocol-specified procedures and treatments for study patients across disciplines and sites of care.
Manage patient reimbursement while on clinical trials using study-specific methods.
Deliver compassionate oncology nursing care and coordinate with clinical teams as per protocol requirements.
Provide nursing assessments and documentation for protocol-specified visits, ensuring reconciliation of concomitant medications.
Drive collaboration with medical system staff to ensure timely service delivery to patients.
Grade adverse events using protocol-referenced criteria and document toxicities accurately.
Complete Serious/Unexpected Adverse Event forms and ensure accurate completion of follow-up reports.
Assist with monitoring visits, audits, and provide timely responses to sponsor queries.
Maintain research records for screened and enrolled patients, ensuring compliance with regulations and standards.
Participate in training programs, workshops, and disease-specific meetings to stay up-to-date on departmental objectives.
Provide training and orientation to faculty and staff as needed.
Essential Skills
Three years of relevant clinicalresearch experience.
Bachelor's Degree required.
Solid knowledge of clinicalresearch processes and oncology.
Comfortable communicating with patients.
Experience in pediatric oncology is preferred.
Work Environment
Our vision is to be a leader in scientific discovery, patient care, and education in cancer research. We conduct innovative research and cutting-edge patient-centered care to improve cancer outcomes. The clinical operations team consists of 40 FTEs across disease-specific groups such as breast, lung, phase 1, and GI. We operate in Newark and 12 other sites, with a goal of enrolling 5,000 subjects per year in over 300 active trials across all phases, including both adult and pediatric studies.
Job Type & Location
This is a Contract to Hire position based out of Newark, NJ.
Pay and Benefits
The pay range for this position is $33.00 - $38.00/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 fully onsite position in Newark,NJ.
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.
$33-38 hourly 6d ago
Director of Clinical Research
Aidoc
Clinical research associate job in New York, NY
Aidoc is recruiting a Director of ClinicalResearch in the United States. Join our team!
Aidoc helps health systems deliver smarter and faster care when it matters most. Its mission is to transform patient outcomes through 'always on' clinical AI, eliminating preventable care gaps that lead to loss of lives and disabilities. Through our proprietary ai OS platform, Aidoc seamlessly integrates real-time intelligence into provider workflows, helping physicians make faster clinical decisions for over 45 million patients a year.
With the most FDA-cleared AI solutions in its category and deployments across 150+ health systems globally, Aidoc elevates the physician and patient experience.Backed by General Catalyst, Square Peg, NVentures (NVIDIA's venture arm), and four major U.S. health systems, Aidoc has raised $370 million to date, including a recent $150 million round to accelerate development of CARE, its clinical-grade foundation model.
About this role
We're seeking an experienced Director of ClinicalResearch to lead strategic projects and clinical studies that enhance the clinical credibility of AI in radiology. This role will oversee a growing team, ensuring the development of high-quality clinical evidence that validates the value of our solutions. You will work closely with cross-functional partners in product, data, sales, and marketing, while cultivating strong research relationships with customers and key opinion leaders.
Responsibilities
Lead, mentor, and develop the ClinicalResearch team, with a focus on performance management, capability building, and building a culture of accountability and collaboration.
Partner cross-functionally with Regulatory, Product, and Marketing teams to ensure research priorities support business goals.
Translate company strategic objectives into a clear clinicalresearch roadmap that supports product validation and market adoption.
Oversee prioritization, initiation, and completion of clinicalresearch studies, ensuring they advance organizational goals rather than just individual project milestones.
Establish and optimize end-to-end research processes (study planning, execution, reporting, and dissemination) to drive efficiency, quality, and scalability across programs.
Implement tools, systems, and metrics that enable transparency, accountability, and proactive risk management within the research portfolio.
Drive adoption of standardized workflows and best practices across studies to ensure consistency and regulatory compliance.
Requirements
Bachelor's or Master's degree in Clinical Sciences, Health/Life Sciences, Health Economics, or related field (PhD preferred).
Minimum 5 years of experience managing teams in a clinicalresearch or scientific environment.
Strong track record of delivering clinical studies and publications in peer-reviewed journals.
Deep understanding of clinicalresearch design, statistical interpretation, and data analysis.
Proven ability to lead complex, cross-functional projects in a fast-paced environment.
Exceptional communication and writing skills, with experience presenting at scientific conferences.
Medical or scientific writing expertise.
Working at Aidoc
We're a dynamic, collaborative and fast growing team of more than 400 global employees, committed to improving the world of healthcare. We're looking for mission-driven people excited to do transformative work.
We have offices in Tel Aviv, Barcelona and New York City, but Aidoc is a remote-first workplace. We're able to hire US-based employees across the continental United States, although certain roles may be region-specific.
What we offer:
A range of medical, dental and vision benefits
Stock options for all full-time employees
20 days of paid vacation, plus sick days and holidays
A 401(k) plan, life insurance, plus long and short term disability
The opportunity to directly improve medical care and impact patient outcomes
Aidoc is deeply committed to creating an inclusive and diverse workplace, and to the principle of equal opportunity for all individuals. We prohibit harassment of any type as well as discrimination based on race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, or any other status protected by law.
$87k-139k yearly est. 6d ago
Clinical Trial Associate
Celltrion USA
Clinical research associate job in Jersey City, NJ
About the Company:
Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company.
Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.
POSITION SUMMARY
Reporting to the Vice President, Clinical Development. The Clinical Trial Associate, Late Development (IIT, Registry) [GI] will play a key role in supporting the planning, execution, and management of late phase clinical trials by providing clinical, scientific, and administrative support. The role collaborates closely with the Clinical Trial Manager (CTM) and relevant teams in HQ to ensure effective trial conduct in accordance with applicable regulations and company policies.
KEY ROLES AND RESPONSIBILITIES
Support the preparation and maintenance of clinical trial documentation, including study protocols and Clinical Study Reports (CSRs), in compliance with regulatory and internal requirements.
Provide operational support to Clinical Operations in collaboration with the CTM.
Contribute evidence-based medical and scientific input to late-phase clinical trials under appropriate supervision.
Support site selection activities and participate in site-boosting visits within the United States, as required.
Prepare and maintain scientific literature summaries and assist in the development of clinical data presentations.
Maintain regular communication with cross-functional stakeholders, including teams at Headquarters (South Korea).
Support medical-related activities within the Clinical Development and Medical Affairs department in accordance with applicable laws, regulations, and company policies.
This is a hybrid role. Can work on-site at our Jersey City, NJ office.
WORK EXPERIENCE
Minimum of three (3) years of experience in clinicalresearch, clinical trials, or a related field
Willingness and ability to travel up to approximately 25%, with or without reasonable accommodation
QUALIFICATIONS
Ability to learn and adhere to company policies, procedures, and compliance requirements
Demonstrated ability to work proactively in a regulated environment
Ability to communicate effectively in English, both verbally and in writing
Demonstrated effective written and verbal communication skills
Ability to collaborate effectively across multiple functional teams
Ability to communicate in Korean at an intermediate level is preferred but not required
EDUCATION
Bachelor's degree in Life Sciences, Medicine, Pharmacy, or a related discipline, or an equivalent combination of education and experience.
CORE COMPETENCIES
Knowledge - medical terminology and regulatory requirements.
Communication - clear, concise, and ability to motivate; ability to articulate medical information of the Company's products.
Collaboration - ability to communicate across functions and at all levels in the organization.
Compliance - understands industry regulations to maintain compliance.
Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
#LI-MDRD
$73k-123k yearly est. 3d ago
Associate - Clinical Trial Supply Operations (0-2 Years Experience)
Specialty Pharmasource LLC
Clinical research associate job in Denville, NJ
About Us
Specialty PharmaSource LLC, based in Denville, NJ, is a U.S. wholesale distributor supporting the global healthcare and pharmaceutical sector. We specialize in sourcing FDA-approved branded and generic medications, Comparator Drug Products, and Reference Listed Drugs (RLDs), and in providing clinical trial support services including cGMP packaging, labeling, storage, and global distribution.
We work with pharmaceutical and biotechnology companies, CROs, research institutions, and healthcare partners to deliver reliable, compliant, and timely clinical and commercial supply solutions.
The Opportunity
We are seeking an Associate, Clinical Trial Supply Services to join our growing startup team. This is an early-career role (0-2 years experience) designed for candidates interested in building hands-on expertise in clinical trial supply operations, comparator and RLD sourcing, and global clinical logistics.
This position offers broad exposure across sourcing, documentation, packaging, labeling, and distribution activities, with mentorship from experienced professionals and meaningful responsibility from day one.
Key Responsibilities
Support clinical trial supply operations, including sourcing of RLDs, comparator drugs, and clinical supplies/ancillaries
Assist with procurement and coordination of clinical ancillaries such as diluents, devices, kits, and consumables per protocol requirements
Coordinate cGMP packaging, labeling, storage, and domestic and international distribution activities
Work with suppliers, logistics partners, and internal teams to support timely and compliant execution
Maintain accurate documentation, inventory records, and shipment tracking in accordance with cGMP, GDP, DSCSA, and clinical trial requirements
Support client communications related to order status, availability, and timelines
Assist with proposal preparation, pricing support, and operational documentation
Contribute to process improvements and support the growth of a startup environment
Qualifications
Bachelor's degree in life sciences, pharmacy, supply chain, or a related field preferred
0-2 years of experience in pharmaceutical operations, clinical trials, logistics, or supply chain (internships and co-ops welcome)
Strong organizational skills and attention to detail
Good written and verbal communication skills
Ability to learn quickly, take initiative, and work in a fast-paced startup environment
Interest in clinical trials, pharmaceutical sourcing, and global supply chains
To apply or learn more, please contact us at: ******************************
$73k-122k yearly est. 1d ago
Research Coordinator
Columbia University In The City of New York 4.2
Clinical research associate job in New York, NY
Job Type: Support Staff - Non-Union
Regular/Temporary: Regular
End Date if Temporary:
Hours Per Week: 25
Salary Range: $52,000- $65,000
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary
The Hunt Molecular Biophysics Laboratory at Columbia University lab uses structural, thermodynamic, enzymological, and computational methods to understand the molecular mechanisms of complex biochemical processes.
Hunt Lab is seeking a part-time scientific Research Coordinator position for a project focused on engineering the amino acid and nucleotide sequences of a human protein for use in genetic therapies. The major job responsibilities are coordinating communication and data interchange between four participating laboratory groups at different institutions, managing a publicly accessible project database, and assisting with related grant-reporting and manuscript-writing activities.
This is a part-time role, subject to grant funding.
Responsibilities
Project Communication & Coordination
Serve as the primary liaison between project participants.
Coordinate biweekly Zoom meetings and follow up on action items.
Maintain consistent communication flow to ensure alignment across all sites.
Oversee and coordinate inter-site sample shipments.
Track sample inventory and ensure proper handling and documentation during transit.
Assist with the preparation and submission of progress reports to the funding agency.
Data and Website Management
Coordinate the timely posting of data on the project website.
Ensure proper versioning and data labeling for easy accessibility.
Assist project staff in preparing data for upload to publicly accessible databases.
Make basic content and format updates to the project website.
Organize project resources and data presentations as guided by the team.
Ensure that the website is updated with the latest findings, protocols, and relevant documentation.
Final Data Deposition
Oversee the deposition of final results into publicly available databases.
Assist staff with formatting and submission requirements.
Ensure compliance with funder and institutional data-sharing policies.
Minimum Qualifications
* A bachelor's degree is required in a scientific discipline.
* A minimum of three years of experience is needed in a research environment.
Preferred Qualifications
Master's or PhD degree strongly desirable.
Rudimentary computer programming skills.
Comfort using a standard computer database system.
Two years of continuous laboratory research experience in a related scientific field.
Other Requirements
Basic familiarity with research-level molecular and cellular biology and protein structure studies.
Excellent written, verbal, and interpersonal communication skills.
Ability to maintain high confidentiality and professionalism with a client focus.
Strong multi-tasking, prioritization, and organization skills.
Attention to detail, research, critical thinking, analytical, and problem-solving skills.
Self-starter, a fast learner who can work independently under limited supervision.
Work well in an interactive team environment.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
$52k-65k yearly 6d ago
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 1d 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:
● Develop lesson plans according to the various learning styles of program participants.
● Facilitate groups with the goal of improving literacy skills.
● Identify ways to connect classroom learning with real-world applications, ensuring that participants understand how to apply skills in workplace environments.
● Coordinate with program staff to ensure that participants' progress is being appropriately tracked and supported.
● Continually assess student progress toward mastery of standards and keep students and staff well informed of student progress by collecting and tracking data, providing daily feedback and weekly assessments.
● Provide necessary accommodations and modifications for the growth and success of all students.
● Attend professional development workshops and learning communities that will discuss RLA and Social Studies subtests, as well as curriculum development for the GED exam.
● Administer and utilize standardized assessments to develop curricula targeting the educational challenges of the students.
● Monitor students' performance and attendance for required reporting systems.
● Assist in the evaluation of participant engagement and curriculum effectiveness.
● Collaborate with case managers and program leads to ensure participants' holistic success in the program.
● Maintain flexibility to support program and agency-wide goals as needed
● Implement strategies to maximize student retention.
QUALIFICATIONS & REQUIREMENTS:
Required & Preferred Qualifications
● Bachelor's Degree in Education or comparable field required.
● Minimum of two years of experience overseeing young adult learners of varied ages, levels, and diverse cultural backgrounds.
● Knowledge of ABE and GED curricula, testing procedures, and requirements.
● Demonstrated ability in youth development
WORKING CONDITIONS
● Participation in all staff meetings and staff training seminars.
● Participation in agency-wide programs and program committees, as assigned.
● Active involvement as a supervisee in the supervision process.
● Support the mission of Commonpoint.
● Other tasks appropriate to the Commonpoint staff, as assigned.
BENEFITS AND PERKS
The benefits package includes comprehensive health, vision, and dental insurance, along with life insurance and a pension plan. Employees can take advantage of a flexible spending account and commuter benefits to help manage expenses. Paid time off (PTO) and floating holidays provide flexibility for personal time and work-life balance. The agency also offers a voluntary 403(b) retirement plan for additional financial security. Employees can enjoy various agency perks, including access to fitness centers, pool clubs, and discounts on agency programs. Additionally, the agency supports professional development through a scholarship program and a mentorship program.
JOB DETAILS
Annual Salary: $50,000 - $55,000
Non-Union Position
Location: Commonpoint Bronx Center, 1665 Hoe Ave, Bronx, NY 10460
How to Apply
Send resume and cover letter to Zachary Smith at **********************
$50k-55k yearly 4d ago
Physician Assistant / Clinical Research / New York / Locum Tenens / Physician Assistant-Certified
Manhattan Medical Arts
Clinical research associate job in New York, NY
Physician Assistant
Join our dynamic healthcare team as a Phyician Assistant dedicated to providing high-quality patient care in a fast-paced environment. As a Physician Assistant, you will play a crucial role in delivering comprehensive healthcare services to patients, collaborating with physicians and other healthcare professionals to ensure optimal patient outcomes.
Responsibilities:
- Conduct thorough patient assessments, including medical history reviews and physical examinations.
- Develop and implement individualized care plans for patients, focusing on preventive care, health maintenance, and disease management.
- Collaborate with interdisciplinary teams to coordinate patient care and ensure continuity of treatment.
- Offer health coaching and education to patients on disease prevention, medication management, and lifestyle modifications.
- Maintain accurate and detailed medical documentation in compliance with regulatory standards.
- Participate in clinicalresearch activities and contribute to the advancement of healthcare knowledge and practices.
- Engage in utilization review processes to optimize healthcare resource allocation and patient outcomes.
Qualifications:
- Valid Physician Assisitant license in New York.
- Certification as a Physican Assistant from an accredited certifying body.
- Proficiency in medical documentation systems and electronic health records.
- Strong clinical skills with a focus on evidence-based practice.
- Excellent communication skills with the ability to interact effectively with patients, families, and colleagues.
- Demonstrated commitment to ongoing professional development and continuing education.
Join our team, where you can make a difference in the lives of patients every day. We offer competitive compensation, opportunities for growth, and a supportive work environment dedicated to excellence in patient care. Apply now and embark on a rewarding career as a Physician Assistant with us.
Job Type: Full-time
Pay: $140,000.00 - $160,000.00 per year
Benefits:
Dental insurance
Employee discount
Flexible schedule
Health insurance
Life insurance
Paid time off
Vision insurance
License/Certification:
PA-C (Required)
Work Location: In person
$39k-57k yearly est. 16h 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. 16h ago
Weekend Clinic Coordinator
Breakway Hoops
Clinical research associate job in New York, NY
Weekend Clinic Coordinator position requires a highly motivated, knowledgeable and dynamic individual who is responsible to assist in the day-to-day organization of the Weekend Clinic Programming. Responsibilities • With support from senior staff, develop and schedule activities that fulfill the program's objectives and that address the needs and interests of students and families
• Assist in recruiting children and families to participate in the program
• Assist in hiring, supervising and support a staff
• Assist in the interviewing, managing, training, and coaching of program staff and volunteers
• Assist in creating a strong sense of community which values respect, acceptance, and high expectations
• Review lesson plans weekly; support the development of curriculum maps and activity plans
• Participate in community outreach programming
Requirements
• Strong commitment to Breakaway Hoops' mission to educate for social responsibility and to foster students' social and emotional learning
• 2 year degree required; BA a plus
• 3+ years experience leading highly effective youth programming
• Excellent social and emotional skills
$52k-74k yearly est. 6d ago
Clinical Research Coordinator - Part Time
Bethany Medical Clinic 4.2
Clinical research associate job in New York, NY
About the Job Job Title: Certified ClinicalResearch Coordinator (CCRC) Part-Time | One Day per Week (On-Site) 222 East 31st street, second floor, New. York, NY 10016 We are seeking a Certified ClinicalResearch Coordinator (CCRC) to join our growing clinicalresearch site on a part-time basis (one day per week). This role is ideal for an experienced coordinator who values high-quality research, operational excellence, and schedule flexibility.
The CCRC will play a critical role in ensuring the ethical, regulatory, and operational integrity of clinical trials while supporting investigators, participants, and sponsors in a highly organized and patient-centered environment.
Key Responsibilities:
Coordinate and manage assigned clinical trials in compliance with GCP, ICH, FDA regulations, and IRB requirements.
Serve as the primary point of contact for study participants, investigators, sponsors, and CROs on assigned study days.
Conduct study visits, including participant screening, informed consent, visit coordination, and protocol-specified procedures.
Ensure accurate, timely, and complete documentation in source documents, EDC systems, and regulatory binders.
Support monitoring visits, audits, and inspections, ensuring readiness and responsiveness.
Maintain study supplies, investigational product accountability, and specimen handling per protocol.
Collaborate closely with the Principal Investigator and research leadership to support study success.
Qualifications:
Certified ClinicalResearch Coordinator (CCRC) required.
Minimum 2+ years of hands-on clinicalresearch coordination experience.
Strong working knowledge of GCP, ICH, FDA regulations, and IRB processes.
Experience working directly with sponsors, CROs, and monitors.
Excellent organizational skills with high attention to detail.
Professional, patient-centered communication style.
Ability to work independently and efficiently in a focused, one-day-per-week role.
Preferred Experience:
Experience in industry-sponsored clinical trials.
Familiarity with EDC platforms (e.g., Medidata, REDCap, Veeva, or similar).
Experience across multiple therapeutic areas (not required).
Schedule & Commitment:
One consistent day per week (on-site).
Ideal for professionals seeking:
Supplemental income.
Portfolio or semi-retired work.
Balance alongside another research or clinical role.
What We Offer:
Competitive hourly compensation commensurate with experience.
A highly organized, collaborative, and respectful research environment.
The opportunity to contribute meaningfully to clinicalresearch without a full-time commitment.
Stable, predictable schedule with minimal administrative burden.
How to Apply
Please submit your CV and a brief cover note highlighting your clinicalresearch experience and availability.
AboutBethany Medical Clinic
About Bethany Medical Clinic of New York:At Bethany Medical Clinic, we value our patients' time and busy schedules. That is why we offer early morning and after work hour appointments at our conveniently located Murray Hill office in New York City. Our goal is to keep waiting time to a minimum and maximize our high level of expertise in an efficient manner during your appointment. You can expect a personalized, non-corporate approach and compassionate care. We embrace the contemporary philosophy that primary care should be predictive, rather than reactive. We not only listen to our patients, but we help them shape their own healthcare journey. Visit our website at *************** for more information!
$46k-68k yearly est. 6d ago
Clinical Coordinator, Transitional Housing
Common Ground 3.2
Clinical research associate job in New York, NY
Reporting to the Assistant Program Director, Transitional Housing the Clinical Coordinator, Transitional Housing supervises Case Managers and ensures the utilization of Harm Reduction and Housing First strategies and other best-practice clinical interventions to ensure the highest quality care for clients. The Clinical Coordinator is responsible for client records are kept in compliance with regulatory and agency standards.
The Clinical Coordinator works primarily during business hours Monday-Friday, with off hours availability in case of emergency or for special projects/initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Supervise a team of Case Managers
Provide regular, structured supervision meetings for direct reports
Promote effective strategies for case management following Housing First, Harm Reduction, Crisis Prevention Institute (CPI), Motivational Interviewing and trauma-informed care models of practice
Development and implement individual service plans; ensure documentation of client contact and progress is comprehensive and timely
Interview and assess potential clients
Provide clinical direction and leadership to the program, help troubleshoot, problem solve, and strategize solutions around client engagement and challenging behaviors
Promote a staff and resident culture that emphasizes housing placement as a measurement of success; ensure that clients are ready for housing placement
Oversee development and implementation of individual service plans; ensure documentation of client contact and progress is comprehensive and timely
Assess and evaluate client functioning
Supervise and conduct case conferences
Coordinate delivery of care with multiple service providers, particularly outreach teams.
Work collaboratively with outreach teams to ensure individuals succeed in transitional housing and avoid return to homelessness
Provide support and guidance to front line staff in managing difficult situations and successfully de-escalating conflict
Perform other duties as assigned
MINIMUM QUALIFICATIONS:
NYS Licensed Masters Social Worker (LMSW) required. Must obtain LMSW within first six months of employment
Minimum 3 years of experience with related populations; previous supervisory and administrative experience preferred
Thorough clinical understanding of relevant service delivery concepts and structures including Housing First, client centered motivational interviewing, Harm Reduction models, behavioral and medical health systems, and the ability to access and negotiate the full range of services for recipients
Experience with crisis intervention, including, risk assessments and incident management
Ability to work successfully with a wide range of internal and external stakeholders
Demonstrated success in working in a fast-paced environment with multiple priorities
Ability to delegate and motivate staff to achieve deliverables
Ability to communicate (verbally and written) with diverse populations and stakeholders
Proficiency with Microsoft Office Suite programs including Word, Excel, Outlook, and Microsoft Teams; familiarity with Access-based databases and the ability to learn new programs are required
Bilingual preferred
If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research and development, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs, as well as for our partners across major therapeutic areas.
Senior Clinical Trial Associate/Clinical Trial Associate
Apply
Summary of Position
Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Trial Associates (CTA). This role will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents, assisting with study start-up, conduct and close-out of study activities. This individual will have accountability for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF).
Key Responsibilities
Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation.
Set up and maintain study-specific paper and electronic TMFs.
Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices.
Track and report CRO's ability to maintain TMF health metrics on an ongoing basis.
Process essential documents and ensure they are correctly filed in the appropriate TMF.
Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed.
Participate in GxP audits and related clinical operations compliance and inspection readiness activities.
Prepare and track study documents (e.g., contracts, budgets, IRB documentation).
Assist with information gathering, literature searches, and creation of presentations, as needed.
Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.)
Administer user access and change control within Anavex's electronic systems.
Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems.
Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards.
Assist with vendor management and associated logistics, as assigned.
Contribute to the creation of presentations, as needed for project, departmental, sponsor, and/or business development presentations.
Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies.
Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel)
Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual.
Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management.
Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF.
Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
Assist in creating and implementing departmental SOPs and procedures.
The position will be filled at a level commensurate with experience.
Requirements
BS/BA in Life Sciences or equivalent
3+ years of experience in similar positions in Biotech, Pharmaceutical, or clinicalresearch organization environment
Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC/ QR, and query management.
Familiar with the DIA reference model
Knowledge of ICH/GCP and applicable regulations
Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence the decision-making of managers, and working partners (local and global)
Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining a high attention to detail and responding to rapidly changing priorities and aggressive deadlines
Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox
Strong critical thinking, organizational and time-management skills
Ability and willingness to travel (up to 10% of the time)
Your Path to Unique Opportunities
If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) diseases, pain, and various types of cancer. Further information is available at ************** .
EOE/M/F/V/SO Anavex Life Sciences Corp. is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status. Visit anavex.com/eeo-policy-statement to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Stay Connected
Follow us on social media
Letter from the CEO
Our Values
Contact Us
$79k-131k yearly est. 6d ago
Clinical Trial Specialist
Actalent
Clinical research associate job in Newark, NJ
We are seeking a dedicated Clinical Trial Specialist to join our team, focusing on protocol activation and study accrual. This role involves collaborating with various departments to initiate and activate new clinical trial protocols, ensuring compliance with regulatory requirements, and providing high-quality patient care. The successful candidate will facilitate communication between patients and research teams, manage protocol-specific orders, and ensure adherence to study guidelines.
Responsibilities
+ Collaborate with the Protocol Activation office to initiate and activate new clinical trial protocols, utilizing study-start up task lists.
+ Prepare and review study tools, including study binders, medication diaries, eligibility checklists, and flow sheets.
+ Verify Scientific Review Board (SRB), Institutional Review Board (IRB), data collection plans, and finance/contract approvals prior to study activation.
+ Conduct protocol-related nursing education to facilitate safe, effective care of enrolled patients.
+ Translate finalized protocol treatment plans, study calendars, and clinical trials billing grids into sample orders.
+ Coordinate with the clinicalresearch team for timely prescreening of potential subjects and active cancer patients for available clinical trials.
+ Review patient charts and medical history to confirm protocol eligibility and obtain source documents as needed.
+ Ensure informed consent processes are followed, and consent is obtained, signed, and documented in medical records.
+ Provide back-up support for registering consented research patients with study sponsors and input data into the clinical trials database.
+ Serve as a resource for Clinical Trial Billing Information related to assigned studies.
+ Act as a link between patients and research team members, addressing and communicating challenges in protocol procedures.
+ Ensure accurate execution of protocol-specific orders, scheduling, and completion of tests and appointments.
+ Coordinate protocol-specified procedures and treatments for study patients across disciplines and sites of care.
+ Manage patient reimbursement while on clinical trials using study-specific methods.
+ Deliver compassionate oncology nursing care and coordinate with clinical teams as per protocol requirements.
+ Provide nursing assessments and documentation for protocol-specified visits, ensuring reconciliation of concomitant medications.
+ Drive collaboration with medical system staff to ensure timely service delivery to patients.
+ Grade adverse events using protocol-referenced criteria and document toxicities accurately.
+ Complete Serious/Unexpected Adverse Event forms and ensure accurate completion of follow-up reports.
+ Assist with monitoring visits, audits, and provide timely responses to sponsor queries.
+ Maintain research records for screened and enrolled patients, ensuring compliance with regulations and standards.
+ Participate in training programs, workshops, and disease-specific meetings to stay up-to-date on departmental objectives.
+ Provide training and orientation to faculty and staff as needed.
Essential Skills
+ Three years of relevant clinicalresearch experience.
+ Bachelor's Degree required.
+ Solid knowledge of clinicalresearch processes and oncology.
+ Comfortable communicating with patients.
+ Experience in pediatric oncology is preferred.
Work Environment
Our vision is to be a leader in scientific discovery, patient care, and education in cancer research. We conduct innovative research and cutting-edge patient-centered care to improve cancer outcomes. The clinical operations team consists of 40 FTEs across disease-specific groups such as breast, lung, phase 1, and GI. We operate in Newark and 12 other sites, with a goal of enrolling 5,000 subjects per year in over 300 active trials across all phases, including both adult and pediatric studies.
Job Type & Location
This is a Contract to Hire position based out of Newark, NJ.
Pay and Benefits
The pay range for this position is $33.00 - $38.00/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 fully onsite position in Newark,NJ.
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
$33-38 hourly 4d ago
Clinical Coordinator III (RN) - DLD (Midtown Practice)
Columbia University In The City of New York 4.2
Clinical research associate job in New York, NY
Job Type: Officer of Administration
Regular/Temporary: Regular
Hours Per Week: 35
Salary Range: $110,000 - $115,000
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary
The Division of Gastroenterology at Columbia University Irving Medical Center is seeking a highly motivated Clinical Coordinator III (RN) to join our premier outpatient care team at our ColumbiaDoctors Midtown West 51st Street location. This ambulatory nursing role is essential in delivering high quality, comprehensive, continuous, and patient-centered care to individuals with a wide range of gastrointestinal conditions. The RN will provide in-person, telephonic, and electronic nursing assessments in accordance with the NYS nursing scope of practice. The position requires strong clinical judgment, excellent communication skills, and the ability to work collaboratively with physicians, advanced practice providers, and administrative staff to ensure optimal patient outcomes. The RN will also participate in quality improvement initiatives and contribute to clinical and research activities within the division.
Responsibilities
Triage patient calls, messages, and symptom reports using sound clinical judgment to address both acute and chronic GI concerns; escalate as appropriate to providers for follow-up.
Coordinate patient care, including referrals, procedures, and follow-up appointments, using the EPIC system.
Provide patient-centered education regarding diagnosis, treatment plans, medications, and procedure preparation or recovery.
Reviews and act on test results (lab, x-ray).
Collaborate closely with three physicians and administrative assistant to facilitate smooth clinic operations and efficient patient flow.
Participate in division-wide quality improvement initiatives and assist with updating nursing policies and procedures as needed.
Serve as a resource to patients and staff for GI-related education and clinical support.
Perform related duties and responsibilities as needed.
Minimum Qualifications
* Bachelor's degree or equivalent in education, training, and/or experience, plus four years of nursing experience.
* Current New York State RN license.
Preferred Qualifications
Bilingual proficiency in English and Spanish.
Prior clinical experience in Gastroenterology, Endoscopy, or General Surgery.
Proficiency with the EPIC.
Other Requirements
Participation in the medical surveillance program
Contact with patients and/or human research subjects
Wear N-95 respirator
Potential bloodborne pathogen exposure
* Successful completion of applicable compliance and systems training requirements
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
$110k-115k yearly 6d ago
Clinical Coordinator, Safe Options Support The Rockaways
Common Ground 3.2
Clinical research associate job in New York, NY
Reporting to the Assistant Director, Programs, Safe Options Support the Clinical Coordinator, Safe Options Support (SOS) supervises Case Managers and Consumer Advocates for the SOS team serving The Rockaways. The Clinical Coordinator also manages a small caseload. The Clinical Coordinator ensures the utilization of Harm Reduction and Housing First strategies and other best-practice clinical interventions to ensure the highest quality care for clients. The Clinical Coordinator is responsible for ensuring client records are kept in compliance with regulatory and agency standards.
The Clinical Coordinator works primarily during business hours Monday-Friday, with off hours availability in case of emergency or for special projects/initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Supervise a team of Case Managers and Consumer Advocates
Provide regular, structured supervision meetings for direct reports
Promote effective strategies for case management following Housing First, Harm Reduction, Crisis Prevention Institute (CPI), Motivational Interviewing and trauma-informed care models of practice
Develop and implement individual service plans; ensure documentation of client contact and progress is comprehensive and timely
Interview and assess potential clients
Provide clinical direction and leadership to the program, help troubleshoot, problem solve, and strategize solutions around client engagement and challenging behaviors
Promote a staff and resident culture that emphasizes housing placement as a measurement of success; ensure that clients are ready for housing placement
Oversee development and implementation of individual service plans; ensure documentation of client contact and progress is comprehensive and timely
Assess and evaluate client functioning
Supervise and conduct case conferences
Coordinate delivery of care with multiple service providers, particularly outreach teams and transitional and permanent housing providers
Provide support and guidance to front line staff in managing difficult situations and successfully de-escalating conflict
Perform other duties as assigned
MINIMUM QUALIFICATIONS:
NYS Licensed Masters Social Worker (LMSW) required. Must obtain LMSW within first six months of employment
Minimum 3 years of experience with related populations; previous supervisory and administrative experience preferred
Thorough clinical understanding of relevant service delivery concepts and structures including Housing First, client centered motivational interviewing, Harm Reduction models, behavioral and medical health systems, and the ability to access and negotiate the full range of services for recipients
Experience with crisis intervention, including, risk assessments and incident management
Ability to work successfully with a wide range of internal and external stakeholders
Demonstrated success in working in a fast-paced environment with multiple priorities
Ability to delegate and motivate staff to achieve deliverables
Ability to communicate (verbally and written) with diverse populations and stakeholders
Valid NY, NJ, CT, or PA driver's license with a good driving record, as defined by Breaking Ground, is required
Proficiency with Microsoft Office Suite programs including Word, Excel, Outlook, and Microsoft Teams; familiarity with Access-based databases and the ability to learn new programs are required
Bilingual preferred
$47k-65k yearly est. 6d 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.
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$30-35 hourly 4d ago
Variable Hours Officer - Clinical Coordinator III / Certified Midwife
Columbia University In The City of New York 4.2
Clinical research associate job in New York, NY
Job Type: Officer of Administration
Bargaining Unit:
Regular/Temporary: Temporary
End Date if Temporary:
Hours Per Week: 5
Standard Work Schedule:
Building:
Salary Range: $ 82.42 - $109.89 p/hour
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary
We are recruiting an energetic and empathetic Variable Hours Officer / Clinical Coordinator III - Certified Midwife to join our team to provide care to patients on the OB/GYN inpatient service at the Allen Pavilion. The Clinical Coordinator III - Certified Midwife will report administratively to the Division Administrator and clinically to the Collaborating Physician. The Midwife will work under the supervision of the attending physicians to provide full-scope management of care to obstetric patients
Responsibilities
Patient Care Management and Documentation
Participates as a member of the healthcare team and interdisciplinary committees to improve patient care and meet patient needs.
Obtains and documents subjective history (interval or comprehensive) as appropriate to chief complaint or reason for visit.
Conducts relevant physical exams, documenting pertinent positive and negative findings.
Identifies a diagnostic impression and/or formulates a differential based on the subjective and objective data obtained.
Writes prescription(s) according to New York State and federal law.
Formulates a goal-directed plan that includes health maintenance, anticipatory guidance, and appropriate medical and nursing interventions according to established protocols/practice agreement.
Assesses and documents patient response to treatment and interventions.
Provides and documents health teaching that is oriented to the appropriate problem and/or developmentally age- appropriate health maintenance.
Consults and/or refers for subspecialty care as appropriate per collaborative agreements/protocols. Documents same as well as documents follow-up.
Direct Patient Care
Provide full scope care to patients in the triage unit, on L&D, and on the PP unit.
Provides direct care to patients that are consistent with the Mission, Philosophy and goals of the hospital. Advises the department within the scope of the advanced nursing practice role and New York State practice act.
Demonstrates a sound knowledge base and clinical decision-making skills in the administration of nurse midwifery care for the obstetric patient population.
Promotes patient satisfaction within their designated patient population.
Quality Assurance
* Conducts review of patient records in collaboration with peers and physician colleagues to determine quality and appropriateness of care provided.
* Engages in ongoing peer review and utilization review activities, competency evaluations and Medical Board reviews.
Patient Safety
* Administers care in accordance with safety, environmental and infectious control principles and regulations identified by the institution and legislative bodies.
* Practices in accordance with legal parameters as delineated by collaborative agreement/practice protocols to include ordering and/or administering medication, intravenous fluids, blood and blood products.
Patient Rights
* Demonstrates an awareness and knowledge of the patient's rights and responsibilities while receiving care within the institution.
* Demonstrates knowledge of the referral mechanism when a patient believes these rights have been violated. Demonstrates knowledge of the hospital's policy governing the application of supportive devices to a patient.
Education
Serves as a resource person and participates in staff development programs.
Provides patient education and counseling on health status and treatment plan.
Serves as clinical preceptor for students from selected programs.
Research Studies
Participates, when appropriate, in quality improvement activities.
Participates in approved research protocols.
Evaluates and implements relevant research findings.
Coordination/Collaboration
Collaborate on clinical problems with nursing personnel, medical staff or other health care providers.
Collaborates with other members of the interdisciplinary team to determine and achieve health goals of patients and families.
Collaborates with administration and professional staff of the hospital in the establishment and implementation of community services.
Other Job Duties
Treats both internal and external customers with courtesy, respect and caring behaviors.
Promotes a safe, therapeutic environment for patients, families and staff.
Acknowledges cultural differences that exist among staff and patients.
Identifies customer services needs on the unit.
Participates in departmental staff meetings and committees as required and appropriate.
Serves as a professional role model for advanced practice for staff, the interdisciplinary team and students.
Performs other job-related duties as assigned.
Note: This position consists inpatient coverage Monday through Sunday (12.5 hours per shift). These shifts will take place during the day and evening, with weekend coverage required
Minimum Qualifications
Master's degree in a health-related field and certification as a Midwife from an approved program, OR a Master of Science Degree in Nursing and certification as a Midwife from an approved program; plus three years of related experience.
Current New York State Midwifery License.
Strong leadership, communication and interpersonal skills to direct work, drive change and effectively collaborate with patients and co-workers.
Must maintain license throughout employment.
Possess strong organizational skills and be detail oriented.
Excellent verbal/written communication and strong observation and listening skills.
High level of professionalism and maturity, and the ability to work independently.
Preferred Qualifications
* 5 years of related experience in OBGYN.
* Computer proficiency with the ability to quickly learn new applications.
The Department of Obstetrics and Gynecology is dedicated to the goal of building a multicultural faculty and staff committed to teaching, working and serving in a diverse community, and strongly encourages applications from candidates of traditionally underrepresented backgrounds.
We are continuously seeking to recruit individuals who will enhance the diversity of our workplace and the effectiveness of our organization.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
How much does a clinical research associate earn in Newark, NJ?
The average clinical research associate in Newark, NJ earns between $43,000 and $101,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.
Average clinical research associate salary in Newark, NJ
$66,000
What are the biggest employers of Clinical Research Associates in Newark, NJ?
The biggest employers of Clinical Research Associates in Newark, NJ are: