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Clinical Research Associate monitors clinical trial sites, ensures protocol compliance, manages investigational products, and maintains communication between sponsors and study sites.
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
You will:
For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
Reviews pathology tissue samples for accuracy and completeness, interprets reports, performs data entry, and escalates discrepancies in a laboratory setting.
PRIMARY RESPONSIBILITIES:
Leverage multiple information sources, including LIMS, to review cases for accuracy and completeness of pathology tissue samples for Signatera and Altera testing.
Interpret pathology reports, clinical notes and additional testing reports to complete light data entry for each tissue sample.
Collaborate with team members to work to resolve potential discrepancies.
Ensure that necessary notes and holds are placed on cases for non-conforming samples, discrepancies and/or missing information and escalated to ensure timely resolution.
Confirm cancer types for the reporting team before the report is issued via emails and spreadsheet.
Meet daily case metrics.
Attend interdepartmental meetings.
Provide feedback on the current process or workflow.
Review and understand all SOPs.
This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job Employee must complete training relating to HIPAA/PHI privacy.
QUALIFICATIONS:
BS/BA degree (preferred)
High School Diploma (or equivalent) required.
2+ years of medical industry related experience - pathology preferred.
Previous data entry experience is required.
KNOWLEDGE, SKILLS, AND ABILITIES
Trained on all product types and able to QC with high accuracy and efficiency consistently.
Ability to handle most escalations, discrepancies, and holds.
Firm understanding and knowledgeable in all aspects of the Sample Review process and SOPs.
Typing speed of at least 45wpm with high accuracy.
Excellent oral and written communication.
Excellent critical thinking skills and the ability to use good judgment.
Ability to perform required duties with a high degree of accuracy and attention to detail.
Positive attitude and ability to work well with others.
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
Registered nurse conducts admissions assessments and initiates care plans for home health patients in a high-volume setting.
Licensed nurse reviews and audits clinical documentation and MDS assessments for compliance and quality assurance.
Reviews medical claims and cases to assess medical necessity and appropriateness of care across multiple healthcare service lines.
Provides telehealth nursing services to patients through Montu's alternative healthcare platform on a part-time basis.
Reviews medical documentation and determines reasonable accommodations for employees as a clinical medical reviewer.
Telehealth physician providing remote medical consultations in internal medicine, ENT, or pulmonology via telemedicine platform.
Nurse Practitioner provides after-hours clinical care and medical decision-making for older adults on a national remote team.
Reviews genetic and molecular testing cases to provide clinical guidance and counseling support for patients and healthcare providers.
Manages medical records collection and documentation processes while supporting revenue cycle operations and client outreach in healthcare settings.
Supports clinical trial operations and regulatory processes at a contract research organization serving the pharmaceutical and biotech industries.
Licensed therapist provides direct virtual mental health care to patients as an independent contractor.
Educates oncology nurses and healthcare professionals on cancer treatment protocols, patient care best practices, and pharmaceutical products in Louisiana and Alabama regions.
Conducts clinical admissions assessments and intake evaluations for patients seeking mental health and behavioral health treatment.
Associate Director of Clinical Studies manages clinical trial design, execution, and data analysis to support microbiome-based product development and regulatory submissions.
About Pendulum:
Pendulum is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics (probiotics + prebiotics) that have demonstrated utility in addressing conditions like metabolic syndrome, inflammation and neurodegeneration.
Pendulum has created a unique discovery platform that utilizes genome sequencing and advanced computational approaches to identify novel, proprietary bacterial strains that augment key functions within the gut microbiome relevant to the respective disease state.
We are a highly collaborative team of scientists, engineers, physicians, manufacturing professionals, and marketing specialists interested in improving human health by leveraging the latest research from diverse fields, such as microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition. We believe strongly in an individual’s transparency and strong communication to enable the most effective and efficient path to team success.
If you’re interested in building a new category of products that will help improve the lives of people globally and you love working in a fast-paced, cross-functional, collaborative, inspiring environment, please continue reading!
Position Summary:
Pendulum is seeking an Associate Director of Clinical Studies to support the clinical team and contribute to the generation of clinical data to support current and future innovative microbiome-based products.
In this position, the candidate will work directly with the Chief Medical Officer to support the execution of a wide variety of clinical research activities including the management of clinical health surveys, execution of clinical trials and external clinical collaborations. The candidate should be a self-starter with expert attention to detail and coordination skills. The candidate will oversee the design and management of clinical health surveys, customer studies and clinical trial planning, design, preparation, management, evaluation and documentation.
Create, update, and manage clinical health surveys, oversee data integrity, and coordinate and oversee data analysis efforts through dashboard development and reporting, with the goal of achieving actionable insights, marketing claims generation and exploratory signals to inform future clinical trials
Support customer studies to enable claims and new insights for product, marketing and revenue teams
Coordinate and support several concurrent clinical research activities, including contributing to protocol design, day to day operations, and data collection & management. This will include single-site, multi-site and investigator-initiated trials with the aim of building scientific credibility and insights for Pendulum products.
Act as a liaison between internal teams and outside clinical collaborators while overseeing protocol adherence and compliance, addressing any issues related to study products (product labeling, shipments, storage, etc), procedures, participant issues or adverse events, and manage external vendor relationships, as needed.
Help assure compliance with all relevant regulatory agencies, implement and maintain periodic quality control procedures, and maintain regulatory documentation
Ensure all clinical trial activities remain in compliance with Good Clinical Practice (GCP)
Coordinate internal activities and communications including clinical team meetings, manage action items, track research progress, budget and quality standards.
Coordinate and support the internal and external review of clinical study protocols, amendments and related documents, informed consent forms, study operations manuals, monitoring plans, and other study essential documents.
Support and track IRB submissions and approvals
Support clinical site management including taking an active role in site selection, training, timely entry of data into the study database and management of CRA clinical site monitoring visits.
Collaborate with in-house marketing and creative team on asset development related to clinical activities, including but not limited to conference collateral, presentations, white papers, case studies, blog posts, email communication, and website copy
Support a cross-functional team, including the Revenue team, Marketing, Manufacturing, Data, and Research & Development
Bachelor’s Degree, preferably in biological science, nursing, dietetics, life sciences, or medical science
Minimum of 3 years experience in clinical trial coordination/program/project management
Minimum of 3 years experience in a clinical organization
Knowledge and experience of ICH GCP standards
Experience with Investigator Brochures as well as Investigational New Drug Applications
Ability to understand and carefully follow regulatory guidelines, procedures and safety guidelines related to clinical trials research
Excellent organizational skills with attention to detail
Strong communication and critical thinking skills actively contributing ideas, energy and desire to succeed as a team with a strong personal and professional drive to get things done
Ability to master new systems quickly and adapt to constantly changing needs
Experience in establishing the infrastructure required to implement and execute efficient clinical studies
Data oriented, with the ability to quickly learn new systems and applications. Preferred experience with electronic data capture (EDC) or electronic survey tools, such as Qualtrics
Experience working with project tracking software such as Asana, Jira, etc.
Flexibility to think and work outside the box in the design, conduct and implement clinical trials including the willingness to explore novel approaches to the conduct of studies
Proficient scientific and clinical understanding of microbiome science or the willingness and ability to learn quickly
Experience in implementing and prioritizing work across multiple projects under tight time constraints
Demonstrated ability to work independently and be a true “Team Player” who can work cross-functionally to achieve results in a fast paced environment
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Licensed mental health clinician provides therapy, conducts assessments, develops treatment plans, and delivers crisis intervention to diverse populations across New York clinics.
Celebrating 50 years of excellence, New York Psychotherapy and Counseling Center (NYPCC) has been at the forefront of mental health and wellness; assisting children, families, and individuals with behavioral and emotional challenges at our five locations throughout the city.
NYPCC is the leading pioneer of community mental health services, serving over 15,000 clients per month. We run and operate the largest clinic in the State of New York and pride ourselves on innovation and “caring for the community” by providing in-person and telehealth services for our clients, while offering an unsurpassable and competitive compensation structure and benefits package to our team of dedicated employees.
NYPCC is certified by Mental Health America as a Platinum Bell Seal organization, the highest certification possible. NYPCC is proud of our ongoing commitment to employee mental health and well-being.
Why Work at NYPCC:
This is a full-time position that will be located at one of the two child and family mental health clinics located at: 2857 Linden Blvd., Brooklyn (East New York Area) or 102 Pilling St., Brooklyn (Bushwick).
Job Responsibilities:
All your information will be kept confidential according to EEO guidelines.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Salary : $72,800 - $100,000
Compensation commensurate with experience and qualifications.
Licensed mental health clinician provides therapy, conducts assessments, develops treatment plans, and delivers crisis intervention services to diverse populations at community mental health clinics.
Celebrating 50 years of excellence, New York Psychotherapy and Counseling Center (NYPCC) has been at the forefront of mental health and wellness; assisting children, families, and individuals with behavioral and emotional challenges at our five locations throughout the city.
NYPCC is the leading pioneer of community mental health services, serving over 15,000 clients per month. We run and operate the largest clinic in the State of New York and pride ourselves on innovation and “caring for the community” by providing in-person and telehealth services for our clients, while offering an unsurpassable and competitive compensation structure and benefits package to our team of dedicated employees.
NYPCC is certified by Mental Health America as a Platinum Bell Seal organization, the highest certification possible. NYPCC is proud of our ongoing commitment to employee mental health and well-being.
Why Work at NYPCC:
This is a full-time position that will be located at one of the two child and family mental health clinics located at: 2857 Linden Blvd., Brooklyn (East New York Area) or 102 Pilling St., Brooklyn (Bushwick).
Job Responsibilities:
All your information will be kept confidential according to EEO guidelines.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Salary : $72,800 - $100,000
Compensation commensurate with experience and qualifications.
Licensed Practical Nurse coordinates comprehensive care management for chronic disease patients, managing medication, resources, and patient education in a remote setting.
CareHarmony’s Care Coordinators (LPN) (NLC) (LVN) work comprehensively with providers to deliver value-based care management initiatives for their patients
CareHarmony is seeking an experienced Licensed Practical Nurse – LPN Nurse (LPN) (NLC) (LVN) with at least 3 years of direct patient-facing work experience; that thrives in a fast-paced environment, is self-motivated, has impeccable attention to detail, and values the impact they can have on a patient’s healthcare journey.
You will have experience identifying resources and coordinating needs for chronic care management patients.
What’s in it for you?
Responsibilities:
Additional Requirements:
Plusses:
Remote Requirements:
Physical Requirements
Benefits
Pay:
Clinical research associate monitors clinical trials, manages site communications, ensures data integrity, and conducts regulatory compliance activities across study sites.
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
You will:
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.