Clinical Research Assistant jobs at Retina Consultants of Texas - 45 jobs
Clinical Research Assistant
Retina Consultants of Houston 4.0
Clinical research assistant job at Retina Consultants of Texas
Retina Consultants of Texas (RCTX) is seeking a ResearchAssistant to join our innovative team with the mission of Fighting Blindness For The World To See. This position will be responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. This position will be based at the Bellaire Clinic.
Candidates must be able to meet the needs of the patients and providers, and support the Research Department hours of 6:30am-5pm Monday through Friday. Schedules are provided weekly and are based on the provider's clinic, patient and surgery schedules.
Retina Consultants of Texas is the largest and most respected retina-only ophthalmology practice in the United States. Our group consists of 26 world renowned physicians leading the world in retinal care. While serving two major metropolitan markets (and their extensions) our combined culture allows us to best serve our patients, referral sources and our own team of physicians. RCTX also invests heavily in diagnostic equipment, providing state-of-the-art retina imaging, laser and diagnostic capabilities to each patient. This, combined with the clinical expertise of our physicians, an outstanding and devoted staff, and 25 convenient locations to serve our patients.
We worked hard to create our culture as Retina Warriors. We strongly emphasize our core values of Hard Work, Authentic Care and Innovation in everything we do. It is our belief that by investing in our people, our people will be empowered of their own accord to provide the highest quality patient experience.
In addition to being highly challenged professionally, in joining our practice, the following competitive benefits for full-time eligible employees after a 60-day introductory period:
Employee Paid Benefits such as Medical, Dental, and Vision, short-term disability, voluntary life insurance, accident, critical illness, hospital indemnity, pet insurance, HSA pre-taxed contributions, 401 (k) retirement savings contributions both Roth and Traditional options starting date of hire.
Employer Paid Benefits such as long-term disability, $25,000 basic life insurance policy, 3% 401(k) safe harbor contribution, HSA employer contributions, annual performance merit increases, certification opportunities, rewards & recognition platform, WellHub Starter Plan Gym Membership, paid time off and (8) paid holidays + (1) floating holiday annually.
Starting Pay Rate is $19.00 per hour and eligible for overtime.
RCTX is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, age, national origin, disability, military service, veteran status, genetic information, or any other protected class under applicable law.
Responsibilities
Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines.
Prepare visit-specific documentation and charts for ClinicalResearch Coordinator
Inform subjects and obtain written consent in regard to ICF's
Assist Coordinator in patient care and management
Assist Coordinator in monitoring subject flow and assist in subject care and management
Accurately collect and record all necessary data (e.g. demographics, medical history, adverse events, concomitant medications, etc.) during study visit
Transcribe subject study information from source documents to the Electronic Case Report Forms
Administer all mandatory questionnaires to study subjects
Set up, prepare subject, and conduct electrocardiograms on subject who require ECG per study protocol
Scribe ocular exams for doctors and confirm appropriate treatment per protocol
Promptly request all necessary medical records for Serious Adverse Event Reporting
Collection, processing, and shipment of laboratory biological samples for analysis
Perform intraocular pressure checks post-injections
Review and resolve data management queries as needed
Trial frame refraction and ETDRS visual acuity testing
Other duties as assigned
Qualifications
Skills/Competencies:
Biliginual preferred
Ability to multitask
Computer efficient
Commnucates well both verbally and electronically; email, MS Teams, etc.
Detail oriented
Education Requirements
Bachelors degree or 4 years of ophthalmic experience in lieu of degree
Experience Requirements:
No experience required with a Bachelors degree otherwise at least 4 years of ophthalmic experience
$19 hourly Auto-Apply 37d ago
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Clinical Research Associate (PhD Candidates)
Medpace 4.5
Detroit, MI jobs
Join our CRA Team in Cincinnati, Ohio! The ClinicalResearch Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with PhD/Life Science backgrounds who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you!
MEDPACE CRA TRAINING PROGRAM (PACE )
No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence:
* PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA.
* PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums.
* To supplement your in-house and field-based training you may also participate in other clinicalresearch departmental core rotations, learning other aspects of the drug/device development and approval process.
WHY BECOME A CRA
This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including:
* Dynamic working environment, with varying responsibilities day-to day
* Expansive experience in multiple therapeutic areas
* Work within a team of therapeutic and regulatory experts
* Defined CRA promotion and growth ladder with potential for mentoring and management advancements
* Competitive pay and many additional perks unmatched by other CROs (SEE BELOW).
WE OFFER THE FOLLOWING
* Competitive travel bonus;
* Equity/Stock Option program;
* Training completion and retention bonus;
* Annual merit increases;
* 401K matching;
* The opportunity to work from home;
* Flexible work hours across days within a week;
* Retain airline reward miles and hotel reward points;
* Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
* In-house travel agents, reimbursement for airline club, and TSA pre-check;
* Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
* CRA training program (PACE );
* Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
* In-house administrative support for all levels of CRAs; and
* Opportunities to work with international team of CRAs.
Responsibilities
* Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
* Communication with the medical site staff including coordinators, clinicalresearch physicians, and their site staff;
* Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
* Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
* On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
* Verification that the investigator is enrolling only eligible subjects;
* Regulatory document review;
* Medical device and/or investigational product/drug accountability and inventory;
* Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
* Assess the clinicalresearch site's patient recruitment and retention success and offering suggestions for improvement; and
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications
* Must have a minimum of a Bachelor's degree in a health or life science related field;
* Ability to travel 60-70% to locations nationwide is required, or less if remote/virtual visits required;
* Must maintain a valid driver's license and the ability to drive to monitoring sites;
* Minimum 1 year healthcare-related work experience preferred;
* Proficient knowledge of Microsoft Office;
* Strong communication and presentation skills; and
* Must be detail-oriented and efficient in time management.
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
* Cincinnati Campus Overview
* Flexible work environment
* Competitive PTO packages, starting at 20+ days
* Competitive compensation and benefits package
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Community involvement with local nonprofit organizations
* Discounts on local sports games, fitness gyms and attractions
* Modern, ecofriendly campus with an on-site fitness center
* Structured career paths with opportunities for professional growth
* Discounted tuition for UC online programs
Awards
* Named a Top Workplace in 2024 by The Cincinnati Enquirer
* Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
* Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
$59k-97k yearly est. Auto-Apply 7d ago
Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)
Medpace 4.5
San Francisco, CA jobs
ClinicalResearch Coordinators wanted at Medpace! Become a CRA and join our growing team! This is an exciting opportunity for clinicalresearch professionals with at least one year of ClinicalResearch Coordinator experience to fill ClinicalResearch Associate (CRA) openings with Medpace. Through our PACE Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.
WE OFFER THE FOLLOWING
* Competitive travel bonus;
* Equity/Stock Option program;
* Training completion and retention bonus
* Annual merit increases;
* 401K matching;
* The opportunity to work from home;
* Flexible work hours across days within a week;
* Retain airline reward miles and hotel reward points;
* Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
* In-house travel agents, reimbursement for airline club, and TSA pre-check;
* Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
* CRA training program (PACE);
* Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
* In-house administrative support for all levels of CRAs; and
* Opportunities to work with international team of CRAs.
Responsibilities
* Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
* Communication with the medical site staff including coordinators, clinicalresearch physicians, and their site staff;
* Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
* Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
* On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
* Verification that the investigator is enrolling only eligible subjects;
* Regulatory document review;
* Medical device and/or investigational product/drug accountability and inventory;
* Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
* Assess the clinicalresearch site's patient recruitment and retention success and offering suggestions for improvement; and
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications
* Must have a minimum of a Bachelor's degree in a health or science related field;
* Experience as a ClinicalResearch Coordinator (minimum 1 year);
* Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely;
* Must maintain a valid driver's license and the ability to drive to monitoring sites;
* Proficient knowledge of Microsoft Office;
* Strong communication and presentation skills; and
* Must be detail-oriented and efficient in time management.
Compensation
A target salary range of $60,000 - $140,000 with potential for bonus and equity awards. Your compensation will be based on your skills and experience. Medpace offers the following benefits for full-time positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, pet insurance, and reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations). For more details, please discuss with your recruiter.
#LI-Remote
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
* Flexible work environment
* Competitive PTO packages - starting at 20+ days
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Competitive compensation and benefits package
* Structured career paths with opportunities for professional growth
* Discounts for local businesses
Awards
* Named a Top Workplace in 2024 by The Cincinnati Enquirer
* Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
* Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
$60k-140k yearly Auto-Apply 10d ago
Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate) (LA)
Medpace 4.5
Los Angeles, CA jobs
ClinicalResearch Coordinators wanted at Medpace! Become a CRA and join our growing team! This is an exciting opportunity for clinicalresearch professionals with at least one year of ClinicalResearch Coordinator experience to fill ClinicalResearch Associate (CRA) openings with Medpace. Through our PACE Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.
WE OFFER THE FOLLOWING
* Competitive travel bonus;
* Equity/Stock Option program;
* Training completion and retention bonus
* Annual merit increases;
* 401K matching;
* The opportunity to work from home;
* Flexible work hours across days within a week;
* Retain airline reward miles and hotel reward points;
* Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
* In-house travel agents, reimbursement for airline club, and TSA pre-check;
* Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
* CRA training program (PACE);
* Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
* In-house administrative support for all levels of CRAs; and
* Opportunities to work with international team of CRAs.
Responsibilities
* Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
* Communication with the medical site staff including coordinators, clinicalresearch physicians, and their site staff;
* Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
* Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
* On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
* Verification that the investigator is enrolling only eligible subjects;
* Regulatory document review;
* Medical device and/or investigational product/drug accountability and inventory;
* Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
* Assess the clinicalresearch site's patient recruitment and retention success and offering suggestions for improvement; and
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications
* Must have a minimum of a Bachelor's degree in a health or science related field;
* Experience as a ClinicalResearch Coordinator (minimum 1 year);
* Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely;
* Must maintain a valid driver's license and the ability to drive to monitoring sites;
* Proficient knowledge of Microsoft Office;
* Strong communication and presentation skills; and
* Must be detail-oriented and efficient in time management.
Compensation
A target salary range of $60,000 - $140,000 with potential for bonus and equity awards. Your compensation will be based on your skills and experience. Medpace offers the following benefits for full-time positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, pet insurance, and reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations). For more details, please discuss with your recruiter.
#LI-Remote
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
* Flexible work environment
* Competitive PTO packages - starting at 20+ days
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Competitive compensation and benefits package
* Structured career paths with opportunities for professional growth
* Discounts for local businesses
Awards
* Named a Top Workplace in 2024 by The Cincinnati Enquirer
* Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
* Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
$60k-140k yearly Auto-Apply 10d ago
Principal Clinical Research Scientist - Surgical Implants Vision
Johnson & Johnson 4.7
Irvine, CA jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research - Non-MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Irvine, California, United States of America, Milpitas, California, United States of America
Job Description:
About Vision
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
We are searching for the best talent for a Principal ClinicalResearch Scientist - Surgical Implants Vision platform. The role is based on either the Irvine, CA or Milpitas, CA campuses.
Purpose: The Principal ClinicalResearch Scientist - Surgical Implants Vision platform is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinicalresearch (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient.
You will be responsible for:
* Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs
* Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle
* Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.)
* Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
* Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies
* Performs other related duties as assigned by management
Qualifications
* An advanced degree in a Scientific Field is required. A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend.
Other: Post-graduate degree or residency is preferred
* Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required
* Experience with intraocular lenses is preferred.
* Strong technical writing ability, such as clinical study protocols, reports and abstracts is required
* Understanding of biostatistics as applied to study data is required
* Proficient with computers and software programs is required
* Ability to travel 10% of the time is required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
#LI-VY1
#LI-Hybrid
Required Skills:
Preferred Skills:
Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
For Bay Area:
$134,000.00 - $231,150.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
$134k-231.2k yearly Auto-Apply 3d ago
Principal Clinical Research Scientist - Equipment Platform Vision
J&J Family of Companies 4.7
Milpitas, CA jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Discovery & Pre-Clinical/Clinical Development
**Job Sub** **Function:**
Clinical Development & Research - Non-MD
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Irvine, California, United States of America, Milpitas, California, United States of America
**Job Description:**
**About Vision**
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
**We are searching for the best talent for a** Principal ClinicalResearch Scientist - Equipment Platform Vision. The role is based on either the Irvine, CA or Milpitas, CA campuses.
**Purpose:** The Principal ClinicalResearch Scientist - Equipment Platform Vision is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinicalresearch (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient.
**You will be responsible for:**
+ Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs
+ Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle
+ Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.)
+ Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
+ Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies
+ Performs other related duties as assigned by management
**Qualifications**
+ An advanced degree in a Scientific Field is required. A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend.Other: Post-graduate degree or residency is preferred
+ Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required
+ Experience in software-driven medical devices and capital equipment is preferred
+ Strong technical writing ability, such as clinical study protocols, reports and abstracts is required
+ Understanding of biostatistics as applied to study data is required
+ Proficient with computers and software programs is required
+ Ability to travel 10% of the time is required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
\#LI-VY1
\#LI-Hybrid
**Required Skills:**
**Preferred Skills:**
Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management
**The anticipated base pay range for this position is :**
$134,000.00 - $231,150.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
$134k-231.2k yearly 32d ago
Principal Clinical Research Scientist - Equipment Platform Vision
Johnson & Johnson 4.7
Milpitas, CA jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research - Non-MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Irvine, California, United States of America, Milpitas, California, United States of America
Job Description:
About Vision
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
We are searching for the best talent for a Principal ClinicalResearch Scientist - Equipment Platform Vision. The role is based on either the Irvine, CA or Milpitas, CA campuses.
Purpose: The Principal ClinicalResearch Scientist - Equipment Platform Vision is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinicalresearch (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient.
You will be responsible for:
* Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs
* Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle
* Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.)
* Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
* Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies
* Performs other related duties as assigned by management
Qualifications
* An advanced degree in a Scientific Field is required. A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend.
Other: Post-graduate degree or residency is preferred
* Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required
* Experience in software-driven medical devices and capital equipment is preferred
* Strong technical writing ability, such as clinical study protocols, reports and abstracts is required
* Understanding of biostatistics as applied to study data is required
* Proficient with computers and software programs is required
* Ability to travel 10% of the time is required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
#LI-VY1
#LI-Hybrid
Required Skills:
Preferred Skills:
Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management
The anticipated base pay range for this position is :
$134,000.00 - $231,150.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
$134k-231.2k yearly Auto-Apply 3d ago
Principal Clinical Research Scientist - Surgical Implants Vision
Johnson & Johnson 4.7
Milpitas, CA jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research - Non-MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Irvine, California, United States of America, Milpitas, California, United States of America
Job Description:
About Vision
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
We are searching for the best talent for a Principal ClinicalResearch Scientist - Surgical Implants Vision platform. The role is based on either the Irvine, CA or Milpitas, CA campuses.
Purpose: The Principal ClinicalResearch Scientist - Surgical Implants Vision platform is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinicalresearch (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient.
You will be responsible for:
* Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs
* Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle
* Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.)
* Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
* Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies
* Performs other related duties as assigned by management
Qualifications
* An advanced degree in a Scientific Field is required. A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend.
Other: Post-graduate degree or residency is preferred
* Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required
* Experience with intraocular lenses is preferred.
* Strong technical writing ability, such as clinical study protocols, reports and abstracts is required
* Understanding of biostatistics as applied to study data is required
* Proficient with computers and software programs is required
* Ability to travel 10% of the time is required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
#LI-VY1
#LI-Hybrid
Required Skills:
Preferred Skills:
Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
For Bay Area:
$134,000.00 - $231,150.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
$134k-231.2k yearly Auto-Apply 3d ago
Clinical Research Assistant - David Turbay MD PLLC
Elligo Health Research 3.7
El Paso, TX jobs
The ClinicalResearchAssistant plays a key role in assisting with the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary function of the ClinicalResearchAssistant is to support the ClinicalResearch Coordinators (CRCs) and the broader study team in the successful execution of clinical trials to achieve study objectives and corporate goals. This role is responsible for a variety of tasks, including administrative duties, data management/entry, patient interaction and technical procedures such as phlebotomy, performing ECGs and vital signs. Additional focus is on specimen collection, specimen handling and transport, specimen processing, lab manual creation, reviewing lab results and inventory monitoring.
ESSENTIAL DUTIES:
Maintain a safe, clean working environment, including infection control requirements
Perform specimen collections, includes venipuncture to pediatric and adult participants
Process specimens received in the laboratory. This task includes specimen transport, handling, sorting, requisition entry, inventory accountability, and reviewing lab results for PI review.
Performing CLIA waived testing such as urine pregnancy testing, urine dip analysis, urine drug screen testing, alcohol testing, Rapid Antigen Testing
Ensure specimen collection/processing/shipping are performed according to protocol
Complete study training and available for additional duties to support study conduct as needed, which may include:
Assist with the screening, recruiting and enrollment of research subjects.
Assist in the informed consent process of research subjects
Collect patient/research participant history
Data entry and Management per Good Documentation Practice
Coordinate follow-up care and laboratory procedures
Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non- clinical supply materials, imaging and laboratory handling manuals, etc.)
Performing vitals, ECG, spirometry
Coordinate protocol related research procedures, study visits, and follow- up care
Develop strong working relationships and maintain effective communication with study team members
Develop strong working relationships with the investigators and staff to build a foundation of trust and respect
Adhere to an IRB approved protocol
Support the safety of research subjects
Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines
Perform other duties as required and/or assigned.
QUALIFICATIONS:
Experience with Athena EMR preferred
Clear and concise written and oral communication skills to interact effectively with coworkers and study staff (including sponsor/CRO).
Strong organizational skills including the ability to accomplish multiple tasks within established timeframes through effective prioritization of duties and functions in a fast-paced environment.
Ability to recognize and synthesize information
Ability to act and operate independently with minimal daily direction from manager to accomplish objectives
Strong attention to detail and accuracy
Excellent interpersonal and customer relationship skills
Aptitude to work effectively and positively with a team and diverse group of individuals
Basic skill level with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint)
Basic knowledge of medical terminology preferred
EDUCATION AND EXPERIENCE:
Bilingual (English/Spanish) required
Minimum 1 year of experience in clinicalresearch or a patient facing, clinical setting
Associates degree a plus
Certification in phlebotomy, ECGs or similar clinical skills preferred
Requirements
Bilingual (English/Spanish) required
Minimum 1 year of experience in clinicalresearch or a patient facing, clinical setting
Associates degree a plus
Certification in phlebotomy, ECGs or similar clinical skills preferred
$36k-49k yearly est. 60d+ ago
Clinical Research Assistant - David Turbay MD PLLC
Elligo Health Research Inc. 3.7
El Paso, TX jobs
Job DescriptionDescription:
The ClinicalResearchAssistant plays a key role in assisting with the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary function of the ClinicalResearchAssistant is to support the ClinicalResearch Coordinators (CRCs) and the broader study team in the successful execution of clinical trials to achieve study objectives and corporate goals. This role is responsible for a variety of tasks, including administrative duties, data management/entry, patient interaction and technical procedures such as phlebotomy, performing ECGs and vital signs. Additional focus is on specimen collection, specimen handling and transport, specimen processing, lab manual creation, reviewing lab results and inventory monitoring.
ESSENTIAL DUTIES:
Maintain a safe, clean working environment, including infection control requirements
Perform specimen collections, includes venipuncture to pediatric and adult participants
Process specimens received in the laboratory. This task includes specimen transport, handling, sorting, requisition entry, inventory accountability, and reviewing lab results for PI review.
Performing CLIA waived testing such as urine pregnancy testing, urine dip analysis, urine drug screen testing, alcohol testing, Rapid Antigen Testing
Ensure specimen collection/processing/shipping are performed according to protocol
Complete study training and available for additional duties to support study conduct as needed, which may include:
Assist with the screening, recruiting and enrollment of research subjects.
Assist in the informed consent process of research subjects
Collect patient/research participant history
Data entry and Management per Good Documentation Practice
Coordinate follow-up care and laboratory procedures
Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non- clinical supply materials, imaging and laboratory handling manuals, etc.)
Performing vitals, ECG, spirometry
Coordinate protocol related research procedures, study visits, and follow- up care
Develop strong working relationships and maintain effective communication with study team members
Develop strong working relationships with the investigators and staff to build a foundation of trust and respect
Adhere to an IRB approved protocol
Support the safety of research subjects
Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines
Perform other duties as required and/or assigned.
QUALIFICATIONS:
Experience with Athena EMR preferred
Clear and concise written and oral communication skills to interact effectively with coworkers and study staff (including sponsor/CRO).
Strong organizational skills including the ability to accomplish multiple tasks within established timeframes through effective prioritization of duties and functions in a fast-paced environment.
Ability to recognize and synthesize information
Ability to act and operate independently with minimal daily direction from manager to accomplish objectives
Strong attention to detail and accuracy
Excellent interpersonal and customer relationship skills
Aptitude to work effectively and positively with a team and diverse group of individuals
Basic skill level with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint)
Basic knowledge of medical terminology preferred
EDUCATION AND EXPERIENCE:
Bilingual (English/Spanish) required
Minimum 1 year of experience in clinicalresearch or a patient facing, clinical setting
Associates degree a plus
Certification in phlebotomy, ECGs or similar clinical skills preferred
Requirements:
Bilingual (English/Spanish) required
Minimum 1 year of experience in clinicalresearch or a patient facing, clinical setting
Associates degree a plus
Certification in phlebotomy, ECGs or similar clinical skills preferred
$36k-49k yearly est. 25d ago
Clinical Research Coordinator II, (Austin, TX)
Elligo Health Research 3.7
Austin, TX jobs
The ClinicalResearch Coordinator II assists in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills.
RESPONSIBILITES
Develop strong working relationships and maintain effective communication with study team members.
Become the point of contact for the clinic as well as the sponsor for clinic related activities.
Manage multiple concurrent trials.
Completes all protocol related training.
Perform patient/research participant scheduling.
Collect patient/research participant history.
Collects and maintains source documentation.
Performs data entry and query resolution.
Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non- clinical supply materials, imaging and laboratory handling manuals, etc.).
Adhere to an IRB approved protocol.
Assist in the informed consent process of research subjects.
Support the safety of research subjects, report adverse events.
Coordinate protocol related research procedures, study visits, and follow-up.
Assist with the screening, recruiting and enrollment of research subjects.
Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities.
Collect, process and ship laboratory specimens.
Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines.
KNOWLEDGE SKILLS AND ABILITIES REQUIRED
Associates Degree or BS/BA in Life Science or related discipline
Strong interpersonal skills with attention to detail a must.
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems.
WORKING CONDITIONS
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
Some flexibility in hours may be required depending on study needs, possible occasional weekends, and the employee must be available during the “core” work hours of 8:00 a.m. to 4:00 p.m. All full-time employees must work a minimum of 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.
Travel: Local travel, as required.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.
Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.
$42k-61k yearly est. 60d+ ago
Clinical Research Coordinator II, (Austin, TX)
Elligo Health Research 3.7
Austin, TX jobs
The Study Manager (ClinicalResearch Coordinator II) plays a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills.
RESPONSIBILITIES
The Study Manager (ClinicalResearch Coordinator II) will be responsible for coordinating efforts with other study team members in order to achieve protocol objectives and corporate goals.
Key Responsibilities
Ability to recognize and synthesize information about the organizational climate and partner with key individuals to accomplish organizational goals
Develop strong working relationships
Establish and maintain effective communication with key stakeholders and team members
Foster strong working relationships with the clinic and serve as the sponsor for clinic related activities
Manage multiple concurrent trials
Assist with mentoring and training study team members
Completes all protocol related training required for the position
Perform patient/research participant scheduling
Collect patient/research participant history
Collects and maintains source documentation
Performs data entry and query resolution
Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging and laboratory handling manuals, etc.)
Adhere to an IRB approved protocol
Assist in the informed consent process of research subjects
Support the safety of research subjects, report adverse events
Coordinate protocol related research procedures, study visits, and follow-up
Assist with the screening, recruiting and enrollment of research subjects.
Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities
Collect, process and ship laboratory specimens
Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines
Other duties as defined by department and company leaders
QUALIFICATIONS AND EDUCATION REQUIREMENTS
Required
3+ years of experience coordinating clinical trials to be able to perform key responsibilities
BS/BA in Life Science or related discipline
Previous GCP training and certification
Demonstrated ability to build strong teams and relationships
Strong verbal and written skills required
Strong interpersonal skills with attention to detail
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems
Ability to travel for Clinic activities, attend investigator meetings or vendor visits/audits, as required
Strong organization/prioritization skills for the management of multiple concurrent projects
Preferred
Experience with training and mentoring other clinicalresearch professionals
Nursing experience in a clinical setting a plus
WORKING CONDITIONS
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
WORKING SCHEDULE
Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.
TRAVEL REQUIREMENTS
Regular local and regional travel is required for this position.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.
Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.
$42k-61k yearly est. 60d+ ago
Clinical Research Coordinator I
Ora 4.3
Houston, TX jobs
ClinicalResearch Coordinator I
DEPARTMENT: Global Project Delivery
*This role is a per-diem contract opportunity*
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
At Ora, we are building the future of ophthalmic clinicalresearch. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinicalresearch to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 400 employees across North America, Europe, Asia, and Latin America.
The Role:
Ora's ClinicalResearch Coordinator I (CRC I) has close relationships with the subjects who participate in our clinical trials located regionally, domestically, and at times, internationally. You will travel with a team of other CRCs to clinical sites as assigned to conduct world-class research using proprietary methodologies. Once onsite, our CRC I's will administrate various technician-based tasks by collecting, recording, and organizing subject and research information during clinicalresearch study visits while ensuring compliance with clinical project protocol and overall clinical objectives. Our CRC I's will partner with tenured ClinicalResearch Coordinators and Clinical Project Managers to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators.
What You'll Do:
Participate in a 3 week-long introductory onboarding (part virtual, part in person) to prepare to learn and demonstrate mastery in various introductory skill sets required to begin clinic work
Travel to research sites as assigned for study visits to prepare for or continue clinical study conduct
Participate in study start-up activities such as putting together charts, pulling patient charts, ensuring site cleanliness
Contribute to and maintain study documents, including source documentation, case report forms, and regulatory documentation
Perform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments
Prioritize and deliver an exceptional subject experience, putting subject safety and protocol adherence to the forefront of your work
Collaborate with on-site staff, whether they be other Ora team members or clinic-based staff and Investigators
Performs patient screening, recruitment, and enrollment
Perform clinical skills identified in the SOP at study visits
Participate in various parallel and compounding trainings to continue advancement of required clinic skills
Maintain protocol compliance during clinical projects and adherence to work instructions and discretion in handling intellectual property
Remain compliant and timely with SOP, ICH-GCP and regulations
Enter and submit time sheets and expenses related to site travel in a timely manner, following the company expense policy.
Prompt submission of work availability on a monthly basis
Enter data into electronic database and resolves data queries
Be willing to travel domestically up to 90% of the time including back-to-back trips and weekends, if necessary.
Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
Responsibilities may differ from the above based on the specific needs of the business.
What We Look For:
Experience needed for the Role:
Bachelor's degree in Life Sciences OR 1-year experience in a clinical setting
Additional Skills & Attributes:
Previous experience as a research coordinator is strongly preferred
Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications is strongly preferred
Medical skills and/or certifications such as (CPT) certified phlebotomist technician, (EMT) Emergency Medical Technician is preferred
This role requires a flexible schedule, including weekend availability, and the ability to travel domestically as needed
A team player attitude with a strong interest in clinical studies and enjoy interacting with patients
Competencies and Personal Traits:
What We Do:
Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
How We Do It:
IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
Why We Do It:
Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.
Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.
Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good - to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.
We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Our Privacy Policy | Ora (oraclinical.com)
$42k-61k yearly est. Auto-Apply 3d ago
Clinical Research Coordinator I
Ora 4.3
Newport Beach, CA jobs
ClinicalResearch Coordinator I
DEPARTMENT: Global Project Delivery
*This role is a per-diem contract opportunity*
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
At Ora, we are building the future of ophthalmic clinicalresearch. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinicalresearch to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 400 employees across North America, Europe, Asia, and Latin America.
The Role:
Ora's ClinicalResearch Coordinator I (CRC I) has close relationships with the subjects who participate in our clinical trials located regionally, domestically, and at times, internationally. You will travel with a team of other CRCs to clinical sites as assigned to conduct world-class research using proprietary methodologies. Once onsite, our CRC I's will administrate various technician-based tasks by collecting, recording, and organizing subject and research information during clinicalresearch study visits while ensuring compliance with clinical project protocol and overall clinical objectives. Our CRC I's will partner with tenured ClinicalResearch Coordinators and Clinical Project Managers to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators.
What You'll Do:
Participate in a 3 week-long introductory onboarding (part virtual, part in person) to prepare to learn and demonstrate mastery in various introductory skill sets required to begin clinic work
Travel to research sites as assigned for study visits to prepare for or continue clinical study conduct
Participate in study start-up activities such as putting together charts, pulling patient charts, ensuring site cleanliness
Contribute to and maintain study documents, including source documentation, case report forms, and regulatory documentation
Perform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments
Prioritize and deliver an exceptional subject experience, putting subject safety and protocol adherence to the forefront of your work
Collaborate with on-site staff, whether they be other Ora team members or clinic-based staff and Investigators
Performs patient screening, recruitment, and enrollment
Perform clinical skills identified in the SOP at study visits
Participate in various parallel and compounding trainings to continue advancement of required clinic skills
Maintain protocol compliance during clinical projects and adherence to work instructions and discretion in handling intellectual property
Remain compliant and timely with SOP, ICH-GCP and regulations
Enter and submit time sheets and expenses related to site travel in a timely manner, following the company expense policy.
Prompt submission of work availability on a monthly basis
Enter data into electronic database and resolves data queries
Be willing to travel domestically up to 90% of the time including back-to-back trips and weekends, if necessary.
Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
Responsibilities may differ from the above based on the specific needs of the business.
What We Look For:
Experience needed for the Role:
Bachelor's degree in Life Sciences OR 1-year experience in a clinical setting
Additional Skills & Attributes:
Previous experience as a research coordinator is strongly preferred
Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications is strongly preferred
Medical skills and/or certifications such as (CPT) certified phlebotomist technician, (EMT) Emergency Medical Technician is preferred
This role requires a flexible schedule, including weekend availability, and the ability to travel domestically as needed
A team player attitude with a strong interest in clinical studies and enjoy interacting with patients
Competencies and Personal Traits:
What We Do:
Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
How We Do It:
IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
Why We Do It:
Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.
Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.
Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good - to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.
We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Our Privacy Policy | Ora (oraclinical.com)
$49k-71k yearly est. Auto-Apply 3d ago
Clinical Research Coordinator I
Ora, Inc. 4.3
Newport Beach, CA jobs
ClinicalResearch Coordinator I DEPARTMENT: Global Project Delivery * This role is a per-diem contract opportunity* Ora Values the Daily Practice of … Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future of ophthalmic clinicalresearch. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinicalresearch to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 400 employees across North America, Europe, Asia, and Latin America.
The Role:
Ora's ClinicalResearch Coordinator I (CRC I) has close relationships with the subjects who participate in our clinical trials located regionally, domestically, and at times, internationally. You will travel with a team of other CRCs to clinical sites as assigned to conduct world-class research using proprietary methodologies. Once onsite, our CRC I's will administrate various technician-based tasks by collecting, recording, and organizing subject and research information during clinicalresearch study visits while ensuring compliance with clinical project protocol and overall clinical objectives. Our CRC I's will partner with tenured ClinicalResearch Coordinators and Clinical Project Managers to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators.
What You'll Do:
* Participate in a 3 week-long introductory onboarding (part virtual, part in person) to prepare to learn and demonstrate mastery in various introductory skill sets required to begin clinic work
* Travel to research sites as assigned for study visits to prepare for or continue clinical study conduct
* Participate in study start-up activities such as putting together charts, pulling patient charts, ensuring site cleanliness
* Contribute to and maintain study documents, including source documentation, case report forms, and regulatory documentation
* Perform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments
* Prioritize and deliver an exceptional subject experience, putting subject safety and protocol adherence to the forefront of your work
* Collaborate with on-site staff, whether they be other Ora team members or clinic-based staff and Investigators
* Performs patient screening, recruitment, and enrollment
* Perform clinical skills identified in the SOP at study visits
* Participate in various parallel and compounding trainings to continue advancement of required clinic skills
* Maintain protocol compliance during clinical projects and adherence to work instructions and discretion in handling intellectual property
* Remain compliant and timely with SOP, ICH-GCP and regulations
* Enter and submit time sheets and expenses related to site travel in a timely manner, following the company expense policy.
* Prompt submission of work availability on a monthly basis
* Enter data into electronic database and resolves data queries
* Be willing to travel domestically up to 90% of the time including back-to-back trips and weekends, if necessary.
* Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
* Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
* Responsibilities may differ from the above based on the specific needs of the business.
What We Look For:
* Experience needed for the Role:
* Bachelor's degree in Life Sciences OR 1-year experience in a clinical setting
* Additional Skills & Attributes:
* Previous experience as a research coordinator is strongly preferred
* Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications is strongly preferred
* Medical skills and/or certifications such as (CPT) certified phlebotomist technician, (EMT) Emergency Medical Technician is preferred
* This role requires a flexible schedule, including weekend availability, and the ability to travel domestically as needed
* A team player attitude with a strong interest in clinical studies and enjoy interacting with patients
* Competencies and Personal Traits:
* What We Do:
* Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
* How We Do It:
* IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
* Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
* Why We Do It:
* Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.
Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.
Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good - to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.
We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Our Privacy Policy | Ora (oraclinical.com)
$49k-71k yearly est. Auto-Apply 5d ago
Parasitology - Clinical Research
Zoetis 4.9
Kalamazoo, MI jobs
Role Description
Manager I (Parasitology)
US Clinical Operations
Global ClinicalResearch and Development
Veterinary Medicine Research & Development (VMRD)
The successful applicant embodies Zoetis' Core Beliefs: Our Colleagues Make The Difference, Always Do The Right Thing, Customer Obsessed, Run It Like You Own It, and We Are One Zoetis.
Within US Clinical Operations, the candidate will be assigned to one or more Project Teams and will have the following duties and responsibilities:
Participate on project teams to develop and license veterinary parasiticides. As a member of the clinical team, coordinate or lead the coordination of all study activities, including start up, Investigator training, conduct, site monitoring and close out. These may include, but are not limited to:
Prepare study protocols, amendments, deviations, data capture forms, electronic data capture systems, test article documentation and study reports in preparation for submission to regulatory agencies.
Collaborate with multiple internal partner groups to plan, coordinate, conduct, analyze, and report studies.
Develop training materials and conduct training of Investigators and other study site personnel.
Coordinate animal related study activities (i.e. clinical sampling, test material administration and clinical observations).
Serve as the principal communication link between the Sponsor and study sites.
Maintain study files in accordance with SOPs and regulatory requirements.
Implement and execute data management processes including paper and electronic data capture, entry, review, tracking, and verification utilizing electronic tools and centralized data management systems.
Prepare study files, author study reports and review technical section summaries for submission to regulatory agencies (FDA, EMA, EPA).
Lead multi-functional team(s) serving as a project team member or clinical team lead.
Contribute to, review and/or author manuscripts for journal publication. Present results, as needed, both internally and to external scientific audiences.
Travel: approximately 10 - 40% on an annual basis. Variable, depending upon project status.
EDUCATION AND EXPERIENCE:
Educational Background:
Minimum: Bachelor's degree
Desirable: Master's degree
Work Experience/Skills:
Minimum:
Five years' experience as a clinical study coordinator/monitor or in research/product development in the animal health pharmaceutical industry
Experience in the study design and execution of parasitology laboratory clinical studies.
Familiarity with parasitology study designs and models as well as regulatory guidance/expectations for the conduct and execution of parasitology studies.
Previous experience with preparation of regulatory submissions for FDA, EPA and/or EMA for product registration
Previous experience working with veterinary clinics and/or research facilities.
Experience with Good Clinical Practice and/or Good Laboratory Practices.
Ability to work both as a member of a team and independently in a self-directed and self-motivated manner.
Excellent skills in the following competencies: organizing, planning, time management, quality, attention to detail.
Well-developed critical thinking skills with the ability to learn on the fly and problem solve.
Excellent interpersonal skills with very good written and oral communication skills.
Competence with Microsoft Office Products (Outlook, Word, Excel, OneNote, Teams).
Experience in configuring studies in an electronic data capture platform/ eClinical software.
Desirable:
Experience and interest in the conduct and leadership of companion animal clinical field studies.
Education and clinical experience in the field of veterinary technology.
Competence with electronic data capture, eClinical software or remote communication tools.
MS or MPS in Veterinary Parasitology, Veterinary Biomedical Science or Veterinary Public Health.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
$50k-68k yearly est. Auto-Apply 60d+ ago
Full Time Clinical Research Coordinator Exp. w/ Drug Studies
Allergy and Asthma Associates of Southern California 4.3
Irvine, CA jobs
Full Time ClinicalResearch Coordinator Exp. w/ Drug Studies
Allergy & Asthma Associates of Southern California dba. Southern California Research
28202 Cabot Road, Laguna Niguel, CA 92677
Job details
Pay: $24 - $26 an hour
Job type: Full-time
Shift and schedule
8-hour shift
Monday to Friday
Expected hours: 40 per week
Experience: ClinicalResearch Coordinator: 1 year (Required)
Work Location: In person
Benefits
401(k)
Health insurance
Paid time off
Vision insurance
Dental insurance
Full job description
Must have clinical drug study experience. We are a fast-paced research center currently looking to add an experienced research coordinator to our staff. Ideal candidates will possess the following qualifications:
Experience as a clinicalresearch coordinator
Ability to work as a team member
Self -starter and ability to work independently
Excellent communication skills, written and verbal
Organized and attention to detail, ability to work in a fast-paced environment
Ability to adapt to changing schedules
Supply and inventory management
Third party vendor management
Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process
IP management, dispensation, and accountability
Adverse Event management, tracking, reporting, and follow-up
Able to review study protocols, create source documents, maintain regulatory binders
Conduct patient recruitment and enrollment of eligible patients
Experience consenting, screening and randomizing subjects
Ability to multitask, prioritize and identify urgent matters
Able to obtain vital signs, ECG's, give injections
Phlebotomy certified, IATA certified and experience processing labs
Computer skills-including used of Microsoft Office Suite
CCRC or working towards obtaining certification. GCP Certification is required at the very least
Understands GCP, ICH and FDA guidelines and requirements
This role is 100% onsite. Candidates must be willing to relocate before starting work if not already located in the area.
$24-26 hourly 27d ago
Full Time Clinical Research Coordinator Exp. w/ Drug Studies
Allergy and Asthma Associates of Southern California 4.3
Laguna Niguel, CA jobs
Allergy & Asthma Associates of Southern California dba. Southern California Research
28202 Cabot Road, Laguna Niguel, CA 92677
Job details
Pay: $24 - $26 an hour
Job type: Full-time
Shift and schedule
8-hour shift
Monday to Friday
Expected hours: 40 per week
Experience: ClinicalResearch Coordinator: 1 year (Required)
Work Location: In person
Benefits
401(k)
Health insurance
Paid time off
Vision insurance
Dental insurance
Full job description
Must have clinical drug study experience. We are a fast-paced research center currently looking to add an experienced research coordinator to our staff. Ideal candidates will possess the following qualifications:
Experience as a clinicalresearch coordinator
Ability to work as a team member
Self -starter and ability to work independently
Excellent communication skills, written and verbal
Organized and attention to detail, ability to work in a fast-paced environment
Ability to adapt to changing schedules
Supply and inventory management
Third party vendor management
Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process
IP management, dispensation, and accountability
Adverse Event management, tracking, reporting, and follow-up
Able to review study protocols, create source documents, maintain regulatory binders
Conduct patient recruitment and enrollment of eligible patients
Experience consenting, screening and randomizing subjects
Ability to multitask, prioritize and identify urgent matters
Able to obtain vital signs, ECG's, give injections
Phlebotomy certified, IATA certified and experience processing labs
Computer skills-including used of Microsoft Office Suite
CCRC or working towards obtaining certification. GCP Certification is required at the very least
Understands GCP, ICH and FDA guidelines and requirements
This role is 100% onsite. Candidates must be willing to relocate before starting work if not already located in the area.
$24-26 hourly 44d ago
Clinical Research Coordinator II, Katy, TX
Elligo Health Research 3.7
Katy, TX jobs
The Study Manager (ClinicalResearch Coordinator II) plays a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills.
RESPONSIBILITIES
The Study Manager (ClinicalResearch Coordinator II) will be responsible for coordinating efforts with other study team members in order to achieve protocol objectives and corporate goals.
Key Responsibilities
Ability to recognize and synthesize information about the organizational climate and partner with key individuals to accomplish organizational goals
Develop strong working relationships
Establish and maintain effective communication with key stakeholders and team members
Foster strong working relationships with the clinic and serve as the sponsor for clinic related activities
Manage multiple concurrent trials
Assist with mentoring and training study team members
Completes all protocol related training required for the position
Perform patient/research participant scheduling
Collect patient/research participant history
Collects and maintains source documentation
Performs data entry and query resolution
Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging and laboratory handling manuals, etc.)
Adhere to an IRB approved protocol
Assist in the informed consent process of research subjects
Support the safety of research subjects, report adverse events
Coordinate protocol related research procedures, study visits, and follow-up
Assist with the screening, recruiting and enrollment of research subjects.
Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities
Collect, process and ship laboratory specimens
Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines
Other duties as defined by department and company leaders
QUALIFICATIONS AND EDUCATION REQUIREMENTS
Required
3+ years of experience coordinating clinical trials to be able to perform key responsibilities
BS/BA in Life Science or related discipline
Previous GCP training and certification
Demonstrated ability to build strong teams and relationships
Strong verbal and written skills required
Strong interpersonal skills with attention to detail
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems
Ability to travel for Clinic activities, attend investigator meetings or vendor visits/audits, as required
Strong organization/prioritization skills for the management of multiple concurrent projects
Preferred
Experience with training and mentoring other clinicalresearch professionals
Nursing experience in a clinical setting a plus
WORKING CONDITIONS
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
WORKING SCHEDULE
Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.
TRAVEL REQUIREMENTS
Regular local and regional travel is required for this position.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.
Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.
$42k-61k yearly est. 60d+ ago
Clinical Research Assistant
Retina Consultants of Houston 4.0
Clinical research assistant job at Retina Consultants of Texas
Retina Consultants of Texas (RCTX) is seeking a ResearchAssistant to join our innovative team with the mission of Fighting Blindness For The World To See. This position will be responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. This position will be based at the Katy Clinic.
Candidates must be able to meet the needs of the patients and providers, and support the Research Department hours of 6:30am-5pm Monday through Friday. Schedules are provided weekly and are based on the provider's clinic, patient and surgery schedules.
Retina Consultants of Texas is the largest and most respected retina-only ophthalmology practice in the United States. Our group consists of 26 world renowned physicians leading the world in retinal care. While serving two major metropolitan markets (and their extensions) our combined culture allows us to best serve our patients, referral sources and our own team of physicians. RCTX also invests heavily in diagnostic equipment, providing state-of-the-art retina imaging, laser and diagnostic capabilities to each patient. This, combined with the clinical expertise of our physicians, an outstanding and devoted staff, and 25 convenient locations to serve our patients.
We worked hard to create our culture as Retina Warriors. We strongly emphasize our core values of Hard Work, Authentic Care and Innovation in everything we do. It is our belief that by investing in our people, our people will be empowered of their own accord to provide the highest quality patient experience.
In addition to being highly challenged professionally, in joining our practice, the following competitive benefits for full-time eligible employees after a 60-day introductory period:
Employee Paid Benefits such as Medical, Dental, and Vision, short-term disability, voluntary life insurance, accident, critical illness, hospital indemnity, pet insurance, HSA pre-taxed contributions, 401 (k) retirement savings contributions both Roth and Traditional options starting date of hire.
Employer Paid Benefits such as long-term disability, $25,000 basic life insurance policy, 3% 401(k) safe harbor contribution, HSA employer contributions, annual performance merit increases, certification opportunities, rewards & recognition platform, WellHub Starter Plan Gym Membership, paid time off and (8) paid holidays + (1) floating holiday annually.
Starting Pay Rate is $19.00 per hour and eligible for overtime.
RCTX is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, age, national origin, disability, military service, veteran status, genetic information, or any other protected class under applicable law.
Responsibilities
Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines.
Prepare visit-specific documentation and charts for ClinicalResearch Coordinator
Inform subjects and obtain written consent in regard to ICF's
Assist Coordinator in patient care and management
Assist Coordinator in monitoring subject flow and assist in subject care and management
Accurately collect and record all necessary data (e.g. demographics, medical history, adverse events, concomitant medications, etc.) during study visit
Transcribe subject study information from source documents to the Electronic Case Report Forms
Administer all mandatory questionnaires to study subjects
Set up, prepare subject, and conduct electrocardiograms on subject who require ECG per study protocol
Scribe ocular exams for doctors and confirm appropriate treatment per protocol
Promptly request all necessary medical records for Serious Adverse Event Reporting
Collection, processing, and shipment of laboratory biological samples for analysis
Perform intraocular pressure checks post-injections
Review and resolve data management queries as needed
Trial frame refraction and ETDRS visual acuity testing
Other duties as assigned
Qualifications
Skills/Competencies:
Biliginual preferred
Ability to multitask
Computer efficient
Commnucates well both verbally and electronically; email, MS Teams, etc.
Detail oriented
Education Requirements
Bachelors degree or 4 years of ophthalmic experience in lieu of degree
Experience Requirements:
No experience required with a Bachelors degree otherwise at least 4 years of ophthalmic experience