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Clinical Research Director, Immunology & Inflammation (Rheumatology)
Sanofi 4.3
Clinical research coordinator job in Cambridge, MA
The ClinicalResearch Director in Immunology & Inflammation (Rheumatology) leads clinical development strategies and coordinates cross-functional teams to advance therapies for autoimmune and inflammatory diseases. This role involves designing clinical trials, ensuring regulatory compliance, engaging with health authorities, and collaborating with external experts to progress drug discovery and development. The director contributes scientific expertise, facilitates study execution, and represents the company at scientific and regulatory forums.
Job title: ClinicalResearch Director in Immunology & Inflammation (Rheumatology)
Location: Cambridge, MA / Morristown, NJ
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Position Overview:
The ClinicalResearch Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in rheumatologic diseases, incorporate new methodologies, and pro-actively progress study execution. The role will focus on developing innovative therapies for autoimmune and inflammatory diseases, with a particular emphasis on rheumatology.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Create clinical development strategy and plans for one or more assets
Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies
Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
Advance the clinical development plan through internal management review
Lead a clinical sub team to design clinical studies and to create study protocols
Execute the clinical development plan in close collaboration with clinical operations
Advance scientific and clinical knowledge for immunology in rheumatologic diseases
Incorporate new trial, scientific and digital methodologies
Pro-actively progress study execution
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval
Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews)
Serve as a medical expert and provide strategic input to early-stage programs
Collaborate with external experts, key opinion leaders, and investigators to advance clinicalresearch
Represent Sanofi at scientific conferences and regulatory meetings
About You
Experience / Skills:
MD or MD/PhD in a relevant scientific discipline with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization
Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia)
Have experience in novel approaches to translational medicine
Have and maintain deep scientific, technical and clinical knowledge in immunologic/rheumatologic diseases
Expertise in autoimmune and inflammatory diseases, particularly in rheumatology
Demonstrate problem solving skills
Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area
Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment
Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences
Proven track record of scientific publications and presentations at international conferences
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Keywords:
clinicalresearch director, immunology, rheumatology, inflammation, clinical development, pharmaceutical industry, drug discovery, clinical trials, regulatory compliance, autoimmune diseases
$75k-116k yearly est. 3d ago
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Senior Clinical Trial Manager
Clinical Dynamix, Inc.
Clinical research coordinator job in Waltham, MA
Senior Clinical Trial Manager
Description
Reporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company's strategic goals. The level reflects the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities
(including, but not limited to):
Accountable for project related efforts for the delivery of studies or programs that are critical to a product's clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
Supports external vendor selection and management process and assists in the development of RFP's and vendor oversight plans.
Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
Project leadership of the cross-functional study team, including external team members, CROs and vendors.
Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
May provide technical advice to team members.
Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
Interact with clinicalresearch investigators, Key Opinion Leaders and sites.
Interact with Senior Management to report on progress of milestones.
Oversight of study team and site training
Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
Management of study drug distribution and accountability processes and documentation
Oversight of study start-up, study management, data cleaning, and study closeout activities
Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
Requirements
BA/BS degree in Health or Life Sciences required, advanced degree preferred
A minimum 8+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
Exceptional communication and interpersonal skills
Positive team orientated attitude
Must speak fluent English if it is their second language
Advanced proficiency in Microsoft Office and Microsoft Project
Reliable, self-motivated, team player
Detail oriented with excellent organizational skills
Ability to effectively manage multiple tasks and competing priorities in a fast-paced environment
Creative problem solver
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel as needed
The salary range for this position is commensurate with experience
$76k-122k yearly est. 60d+ ago
Clinical Research Associate
Integrated Resources 4.5
Clinical research coordinator job in Lexington, MA
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), ClinicalResearch, Rehabilitation Therapy and Nursing.
Job Description
· The in-house ClinicalResearch Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the the Clinical Project Manager(s).
· The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager.
· The CRA performs work within established protocols under general supervision.
· Assists the study team(s) to deliver the clinical study within agreed timelines.
· Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors. (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.) Provides oversight of Clinical CRO Investigator background checks.
· Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary.
· Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.
· Reviews Clinical Monitoring Reports and correspondence related to restudy and Initiation Visits and follows up with Clinical CRO to resolve open action items.
· Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager.
· Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System.
· Assists and/or participates in planning and conduct of Investigator's Meetings as necessary.
· Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced.
· Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager.
· Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present.
· Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements.
· Assists study team with preparation for audits/inspections Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager.
· Liaises with Transparency group to ensure Clintrials.gov is updated.
Additional Information
Feel free to forward my email to your friends/colleagues who might be available.
Thanks,
Warm Regards,
Kavita Kumari
Integrated Resources, Inc.
Direct: (732) - 844 8725
$57k-84k yearly est. 60d+ ago
Clinical Research Associate - Boston/Northeast
Icon Plc 4.8
Clinical research coordinator job in Cambridge, MA
ClinicalResearch Associate - Boston ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a ClinicalResearch Associate to join our diverse and dynamic team. As a ClinicalResearch Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
* Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
* Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
* Collaborating with investigators and site staff to facilitate smooth study conduct.
* Performing data review and resolution of queries to maintain high-quality clinical data.
* Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
* Bachelor's degree in a scientific or healthcare-related field highly preferred.
* Minimum of 2 years of experience as a ClinicalResearch Associate.
* In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
* Strong organizational and communication skills, with attention to detail.
* Ability to work independently and collaboratively in a fast-paced environment.
* Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
$52k-74k yearly est. 60d+ ago
Clinical Research Associate
Alira Health 4.4
Clinical research coordinator job in Framingham, MA
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Summary
Job Description
ROLE
The ClinicalResearch Associate is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
KEY RESPONSABILITIES
Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits.
Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
Ensures integrity of CRF data through meticulous and thorough source document review and verification.
Conducts investigational product accountability.
Reviews regulatory binder for required documents.
Works closely with in-house CRAs and data management to resolve queries on discrepant data.
Proactively identifies site issues and develops problem-solving strategies for sites.
Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
Conducts audit preparation at study sites as needed.
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
Manages and resolves conflicting priorities to deliver on commitments.
Complies with ICH GCP guidelines, FDA regulations, and company SOPs.
Participates in industry and client meetings.
Performs additional duties as assigned.
DESIRED QUALIFICATION & EXPERIENCE
BS/BA from an undergraduate program or equivalent experience
2 years of clinicalresearch experience
TECHNICAL COMPETENCES & SOFT SKILLS
Ability to travel.
Proven ability to be careful, thorough, and detail-oriented.
Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment.
Self-starter who thrives in a collaborative, yet less structured team environment
Ability to problem-solve unstructured or ambiguous challenges.
Strong command of English, both written and verbal.
Excellent communication and interpersonal skills with customer service orientation.
Proficient with MS Office Suite, particularly Word and Excel.
Permanent authorization to work in the country where you are applying.
Languages
English
Education
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences
Contract Type
Regular
$61k-97k yearly est. Auto-Apply 60d+ ago
Clinical Research Associate - Boston/Northeast
Ire
Clinical research coordinator job in Cambridge, MA
ClinicalResearch Associate - Boston
ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a ClinicalResearch Associate to join our diverse and dynamic team. As a ClinicalResearch Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
Performing data review and resolution of queries to maintain high-quality clinical data.
Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
Bachelor's degree in a scientific or healthcare-related field highly preferred.
Minimum of 2 years of experience as a ClinicalResearch Associate.
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
Strong organizational and communication skills, with attention to detail.
Ability to work independently and collaboratively in a fast-paced environment.
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
$60k-92k yearly est. Auto-Apply 8d ago
Clinical Research Associate
CTTX Health
Clinical research coordinator job in Cambridge, MA
Job Description
Are you passionate about clinicalresearch and ready to make an impact on patients' lives? We're looking for a ClinicalResearch Associate (CRA) to join a fast-growing biotech company (confidential) that's advancing innovative therapies in neuroscience.
What You'll Do:
Conduct site initiation, monitoring, and close-out visits to ensure trials meet the highest quality standards.
Review and verify study data for accuracy and completeness.
Collaborate with site staff and cross-functional teams to solve challenges and keep trials on track.
Identify and escalate any protocol deviations, safety concerns, or data issues.
Requirements
What We're Looking For:
Bachelor's in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus).
3+ years of CRA or site monitoring experience.
Strong knowledge of ICH-GCP and FDA regulations.
Excellent communication, organization, and problem-solving skills.
Willingness to travel as needed (up to 50-75%).
Extra Credit:
Experience with CNS or rare-disease trials.
Benefits
Amazing benefits package starting day one!
$60k-92k yearly est. 26d ago
Clinical Research Associate - Boston/Northeast
Icon Central Laboratories
Clinical research coordinator job in Cambridge, MA
ClinicalResearch Associate - Boston
ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a ClinicalResearch Associate to join our diverse and dynamic team. As a ClinicalResearch Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
Performing data review and resolution of queries to maintain high-quality clinical data.
Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
Bachelor's degree in a scientific or healthcare-related field highly preferred.
Minimum of 2 years of experience as a ClinicalResearch Associate.
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
Strong organizational and communication skills, with attention to detail.
Ability to work independently and collaboratively in a fast-paced environment.
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
$60k-92k yearly est. Auto-Apply 8d ago
Clinical Trial Coordinator
Mindlance 4.6
Clinical research coordinator job in Lexington, MA
• Requires Bachelors degree from accredited US College or University can NOT be remote, no relocation • This is a 6 month contract - may be extended but not guaranteed • Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor)
• Experience with finances, accounting or invoicing a plus
Qualifications
• Requires Bachelors degree from accredited US College or University
Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor)
Additional Information
All your information will be kept confidential according to EEO guidelines.
$56k-79k yearly est. 3d ago
Clinical Research Coordinator I
Massachusetts Eye and Ear Infirmary 4.4
Clinical research coordinator job in Lexington, MA
Site: The General Hospital Corporation
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
The Lurie Center for Autism, a Mass General Brigham program based in Lexington, is a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder (ASD) and other neurodevelopmental disorders. The Center is seeking a ResearchCoordinator I to implement a portfolio of clinicalresearch trials and projects related to ASD.
The ClinicalResearchCoordinator I will work under the supervision of the Senior ClinicalResearch Program Manager, with direction by the Principal Investigators on specific protocols, and will participate in tasks related to all phases of the clinicalresearch including the development, initiation, monitoring, completion, and reporting phases. All activities will be conducted in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP) Guidelines.
Job Summary
Summary
Following established policies, procedures, and study protocols, provides assistance on clinicalresearch studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem) to provide degree equivalency verification.
Does this position require Patient Care?
No
Essential Functions
-Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met.
-Recruiting patients for clinical trials, conducts phone interviews.
-Verifies the accuracy of study forms and updates them per protocol.
-Prepares data for analysis and data entry.
-Documents patient visits and procedures.
-Assists with regulatory binders and QA/QC Procedures.
-Assists with interviewing study subjects.
-Assists with study regulator submissions.
Qualifications
Education Bachelor's Degree Science required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Some relevant research project work 0-1 year preferred Knowledge, Skills and Abilities - Careful attention to detail and good organizational skills. - Ability to follow directions. - Good interpersonal and communication skills. - Computer literacy. - Working knowledge of clinicalresearch protocols. - Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
Additional Job Details (if applicable)
Remote Type
Onsite
Work Location
1 Maguire Road
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$19.76 - $28.44/Hourly
Grade
5
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
EEO Statement:
1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
$19.8-28.4 hourly Auto-Apply 10d ago
Clinical Research Associate
Global Channel Management
Clinical research coordinator job in Cambridge, MA
Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.
Qualifications
ClinicalResearch Associate needs 2-5 years of clinicalresearch experience in industry settings with a bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field
ClinicalResearch Associate requires;
oncology experience strongly preferred
EDC systems
Knowledge of clinical trial methodology as well as the drug research and development process
Knowledge of GCP/ICH Guidelines for clinical studies
ORACLE
CLINICAL TRIALS
CLINICAL MONITORING
ClinicalResearch Associate duties are:
Participation in the evaluation of clinical trial site locations.
Serving
as the sponsor liaison to clinical sites during the activation process,
as the study progresses, and during study close-out.
Traveling to sites as necessary to conduct site qualification, initiation, and close-out (
Collecting
and managing regulatory documentation, to ensure compliance with GCP,
ICH, regulatory authority, and ethics board requirements.
Working
with clinical site staff and investigators to obtain study data, ensure
protocol compliance, and guarantee patient safety.
Ensuring accurate and timely reporting of patient safety issues according to all relevant local and federal requirements.
Participating in regional and global conference calls and meetings to review progress of ongoing clinical trials.
Reviewing incoming clinical data, and preparing reports and presentations on the status of clinical studies.
Helping to draft study manuals and protocol amendments as needed.
Organizing and distributing study supplies and study-related documentation required for conduct of clinical trials.
Coordinating
the movement of laboratory samples between clinical sites and central
laboratories, and tracking the status of samples and resulting
laboratory data.
Additional Information
$31/HR
6 months
$31 hourly 60d+ ago
Study Coordinator (Natick, MA)
Actalent
Clinical research coordinator job in Natick, MA
ClinicalResearch Assistant Needed The role involves monitoring participants using various technology products, collecting data, and ensuring the proper functioning of devices and data collection throughout the study sessions. Great opportunity to gain experience in clinicalresearch!
Schedule:
* Monday - Friday
* 7:30am-3:00pm or 2:00pm-9:00pm *can be flexible*
Responsibilities
* Consent participants according to protocol and take necessary vitals and measurements (height, weight, EKG) throughout the session.
* Ensure participants are properly set up with devices and any monitoring equipment.
* Operate several pieces of instrumentation and observe participants using devices during various activities as per protocol.
* Ensure data monitoring is functioning properly throughout the session and ensure proper data collection.
* Guide participants through the study and support data collection directly.
Required Skills
* Experience in research and data entry.
* Bachelor's Degree in science, exercise science, kinesiology, or biology.
* Technical proficiency to operate test devices and perform data entry.
* Ability to direct participants through the study, with examples of patient care or people interaction.
"Nice to have" Qualifications
* Experience in human subject research and data analysis.
* Familiarity with gym equipment and clinicalresearch.
Pay and Benefits
The pay range for this position is $25.00 - $25.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Natick,MA.
Application Deadline
This position is anticipated to close on Apr 30, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$25-25 hourly 60d+ ago
Clinical Research Coordinator
Gastro Health 4.5
Clinical research coordinator job in Framingham, MA
Gastro Health is seeking a Full-Time ClinicalResearchCoordinator to join our team!
Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours.
This role offers:
A great work/life balance
No weekends or evenings - Monday thru Friday
Paid holidays and paid time off
Rapidity growing team with opportunities for advancement
Competitive compensation
Benefits package
Duties you will be responsible for:
General Administrative
Coordinates with Principal Investigator, local site, and Central Hub to help ensure that clinicalresearch and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures.
Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
Assists Principal Investigator to assure that all key personnel or persons ‘engaged' in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
Cooperates with compliance and monitoring efforts related to sponsored program administration and respond to any audit findings and implement approved recommendations.
Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
Protocol Preparation & Review
Attends investigator meetings as required or requested by the PI.
Collaborates with the Regulatory Specialist to prepare IRB and any other regulatory submission documents as required by the protocol.
Prepares other study materials as requested necessary. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs.
Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
Conduct of Research
Reviews and comprehends the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
Develops and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
Conducts or participates in the informed consent process and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
Registers each participant in CTMS to ensure billing of study procedures to the appropriate funding source.
Coordinates participant tests and procedures.
Collects data as required by the protocol. Assures timely completion of Source Documents.
Maintains study timelines.
Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Gastro Health Research Policy on Investigational Drug/Device Accountability.
Completes study documentation and maintains study files in accordance with sponsor requirements and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
Retains all study records in accordance with sponsor requirements and Gastro Health Research policies and procedures.
Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
Project Closeout
Assists the Principal Investigator and Regulatory Specialist in submission of accurate and timely closeout documents to applicable federal agencies, and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures.
Arranges secure storage of study documents that will be maintained according to Gastro Health Research policy or for the contracted length of time, whichever is longer.
Minimum Requirements
Clinicalresearch experience preferred
Previous phlebotomy skills
High School Diploma
Interested in learning more? Click here to learn more about the location.
Gastro Health is the one of the largest gastroenterology multi-specialty groups in the United States, with over 130+ locations throughout the country. Our team is composed of the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees.
Gastro Health is proud to be an Equal Opportunity Employer. We do not discriminate based on race, color, gender, disability, protected veteran, military status, religion, age, creed, national origin, gender identity, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
We thank you for your interest in joining our growing Gastro Health team!
$51k-65k yearly est. Auto-Apply 60d+ ago
Clinical Research Coordinator
Alcanza Clinical Research
Clinical research coordinator job in Methuen Town, MA
Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinicalresearch company with a network of locations in MA, NH, MI, VA, SC, FL, GA and AL. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The ClinicalResearchCoordinator under the direction of the Site Manager/Director and the Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines. The ClinicalResearchCoordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs.
Key ResponsibilitiesIn collaboration with other members of the clinicalresearch site team works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:
Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines:
Screening of patients for study enrollment;
Patient consents;
Patient follow-up visits;
Documenting in source clinic charts;
Entering data in EDC and answers queries;
Obtaining vital signs and ECGs;
May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
Requesting and tracking medical record requests;
Updating and maintaining logs, chart filings;
Maintaining & ordering study specific supplies;
Scheduling subjects for study visits and conducts appointment reminders;
Building/updating source as needed;
Conducting monitoring visits and resolves issues as needed in a timely manner;
Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
o Filing SAE/Deviation reports to Sponsor and IRB as needed;o Documenting and reporting adverse events;o Reporting non-compliance to appropriate staff in timely manner;o Maintaining positive and effective communication with clients and team
members;o Always practicing ALCOAC principles with all documentation;
Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed;
Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed;
Assist with training of new research assistants and coordinators;
Assist with scheduling and planning for visit capacity for assigned studies;
May set up, train and maintain all technology needed for studies;
May assist with study recruitment, patient enrollment, and tracking as needed;
May handle more complex study assignments and volumes;
May participate in community outreach / education events;
Maintaining confidentiality of patients, customers and company information, and;
Performing all other duties as requested or assigned.
Skills, Knowledge and ExpertiseMinimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential AND 1+ years of clinicalresearchcoordination experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred. CCRC or CCRP credential and BLS certification preferred. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);
Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc
Strong organizational skills and attention to detail.
Well-developed written and verbal communication skills.
Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
Must be professional, respectful of others, self-motivated, and have a strong work ethic.
Must possess a high degree of integrity and dependability.
Ability to work under minimal supervision, identify problems and implement solutions.
Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits
Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
$45k-66k yearly est. 18d ago
Clinical Research Accounting Coordinator
Dana-Farber Cancer Institute 4.6
Clinical research coordinator job in Brookline, MA
This is Part-Time; 24 hours/week role Under direct supervision of the Senior ClinicalResearch Accounts Specialist, the ClinicalResearch Accounting Coordinator is responsible for accounts creation and accounts receivable of financial transactions generated from Dana-Farber Cancer Institute ClinicalResearch activity. Handles basic issues and problems and refers more complex issues to higher -level staff. In the absence of a Senior ClinicalResearch Accounts Specialist this position is under direct supervision of the ClinicalResearch Accounting Manager.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
**Primary Duties and Responsibilities:**
+ Submits study financial account creation requests for each new ClinicalResearch contract budget in a timely manner, as necessary.
+ Maintains master list of study account numbers with applicable study IRB numbers for tracking and reporting purpose.
+ Maintains an updated list of payment contacts for all studies and funding sources, as applicable.
+ Monitors study payment activity and consistently pursues collections from extramural research sponsors and funding sources on all open accounts receivables to ensure timely payments.
+ Tracks, documents, and reports payment collection follow up with study funding sources while maintaining accurate and organized accounts receivable files.
+ Organizes and maintains the ClinicalResearch Accounting central e-mailbox; Responds to study accounts receivable and payment status inquiries via e-mail communications.
+ Receives ClinicalResearch checks and wire payments; identifies and enters payments received to the correct study record in the Clinical Trial Management System (CTMS); Stores copies of all payments received for financial reconciliation purpose; submits payments to Finance for study account deposit.
+ Prepares accounts receivable and other financial reports, forecasts, and analyses, as instructed.
+ Handles basic issues and problems and refers more complex issues to higher level ClinicalResearch Accounting team members; escalates invoice revision and justification requests to the applicable ClinicalResearch Accounting Specialist.
**Knowledge, Skills and Abilities:**
+ Effective oral and written communication skills.
+ Good listening skills.
+ Ability to perform basic math and accounting skills
+ Strong organization skills and attention to detail.
+ Proficiency in data entry and Microsoft Office Suite (especially Excel)
+ Ability to analyze and interpret financial data accurately
**Minimum Job Qualifications:**
+ High school diploma required
+ Bachelor's degree in accounting or finance preferred
+ No experience required
+ Working knowledge of the clinical trials lifecycle preferred
**License/Certification/Registration Required:**
MCA Certification within 1-year of hire
**Supervisory Responsibilities:**
None
**Patient Contact:**
No
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
**EEO Poster**
.
Pay Transparency Statement
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).
$50,800.00 - $59,400.00
$50.8k-59.4k yearly 22d ago
Senior Clinical Research Coordinator
Children's Hospital Boston 4.6
Clinical research coordinator job in Brookline, MA
The Department of Psychiatry and Behaviroal Sciences is seeking a full-time Senior ClinicalResearchCoordinator (Sr. CRC) for the Glahn Laboratory and Early Psychosis Investigation Center (EPICenter) at Boston Children's Hospital. This position is integral to a multidisciplinary team of healthcare professionals (researhcers and clinicians) dedicated to advancing research and treatment focused on children and adolescents with psychotic and affective disorders. By focusing on early onset psychiatric diagnoses, we aim to identify the root causes of psychiatric symptoms, and to improve treatment options and outcomes for patients and their families.
The Sr. CRC will play a vital role in overseeing daily operations of multiple NIH-funded and foundation-funded studies aligned with these aims.Responsibilities include, but are not limited to: developing and implementing best practices for clinicalresearch protocols; collaborating with the Principal Investigator to manage studies; supervising and train research staff; monitor regulatory compliance to uphold hospital and governmental standards.
Our ideal candidate is committed to a long-term tenure with the Glahn Lab and brings at least four years of experience in research study design, management, and coordination.
Key Responsibilities
* Providing strategic oversight of a research portfolio with minimal supervision. Leading the development and implementation of clinicalresearch projects in collaboration with Principal Investigator and/or designees to ensure targets are met on time.
* Developing and implementing enrollment strategies and study documents, including IRB approved research protocols and study materials. Provide analytical, data management, and methodological support in the development of clinicalresearch protocols and data management tools. Assist in the establishment of best practice guidelines for various clinicalresearch protocols.
* Desigining comprehensive training curriculum for research support staff and overseeing training and development initiatives. Supervise the day-to-day activities of research support personnel.
* Oversee the consent and enrollment process for research study participants. Communicates all relevant policies and procedures to address participation inquiries. Evaluate the suitability and selection of prospective study candidates based on clinical knowledge.
* Developing study-specific data management and quality assurance procedures, and ensure compliance at site visits and through periodic review of study data.
* Potentially assist in writing grants and preparing new applications for research funding and in implementation and managing ancillary study grants.
Minimum Requirements
Education
* A Bachelor's degree in psychology or related field, with a minimum of 4 years relevant work experience, OR Master's Degree and 2 years relevant work experience
* A cover letter describing your interest in the position and articulating why you would be an excellent fit for the Glahn Lab is preferred.
Experience
* Strong attention to detail and organizational skills
* Exceptional communication skills to convey critical information, work collaboratively on a team, and resolve conflicts effectively
* Exemplary interpersonal and supervisory skills, to lead by example and mentor research support staff and to foster collaboration within the research team
* Ability to manage complex data collection procedures training
* Oversee participant interview covering clinically sensitive subject matter
* Flexiblity to accomandate a varied schedule, including some evenings and weekends
* Willingness to commit long-term to this role
The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting.
Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.
$53k-74k yearly est. 16d ago
Clinical Research Coordinator
No-Resistance Consulting Group
Clinical research coordinator job in North Andover, MA
:
Headquartered in Birmingham, No Resistance is a clinical trial site management organization that performs clinical trials in urgent care centers throughout the north and southeast. We focus on sample collection and testing trials for lab device manufacturers with the purpose of collecting data to support the device's 510(k) or emergency use approval by the FDA. Notably, the trials we have participated in have directly led to the FDA EUA approval of three separate COVID-19 PCR testing platforms.
No clinical trial experience is required. No Resistance will train the right candidate(s). Hours are Monday-Friday 8:30 am to 5:00 pm with no weekend requirements.
Job Description:
No Resistance is seeking motivated individuals to join our team! In this role, you'll play a pivotal part in the implementation and execution of clinicalresearch projects, ensuring the successful attainment of quality, safety, regulatory, and financial objectives.
Job Duties:
Maintaining regulatory binders, inventory of study-specific and clinical supplies.
Recruiting, and enrolling study subjects.
Obtaining informed consent.
Collecting nasal swab samples.
Testing samples on investigational laboratory PCR analyzers.
Data collection and entry.
Query resolution.
Assuring protocol compliance and efficient workflow including organizing clinical work areas, tracking and ordering study supplies and shipping materials, checking and replacing expired items, etc.
Key Success Factors:
Ability to work independently.
Desire to work in a clinical environment with direct patient contact.
Genuine interest in research.
Timely in all communications.
Superior attention to detail.
While not a requirement, senior pre-medical students who hope to gain experience in clinicalresearch or recent graduates who have a "gap" year before they start medical school are encouraged to apply. This position offers an exceptional opportunity to earn a competitive income while gaining invaluable experience highly regarded by medical school admission committees.
Job Type: Full-time
Pay: $25.00 per hour
Expected hours: 40 per week
Benefits:
401(k)
Dental Insurance
Health Insurance
Paid time off
Vision Insurance
Schedule:
Monday to Friday
Work Location: In person
$25 hourly 11d ago
Part-Time Study Coordinator
University System of New Hampshire Portal 4.3
Clinical research coordinator job in Durham, NH
The Dao Research Lab at the University of New Hampshire is seeking a part-time study coordinator to support ongoing research projects in the lab. Description of tasks : The study coordinator will assist in the implementation of a project studying the relationship between weight status, dietary fiber, the gut microbiota, and metabolic health in NH Hispanics at risk for food insecurity. This will include communication with community partners, coordination of recruitment and study visit activities, interaction with other team members including lab staff and phlebotomists. Responsibilities include : · assisting in study recruitment efforts · coordinating community-based study sessions · participant screening and scheduling · overseeing biological sample collection and transportation · ensuring proper storage of biological samples · overseeing study sessions and assessments · maintaining participant confidentiality and privacy · data entry and cleaning The university actively creates and nurtures a dynamic learning environment in which qualified individuals of differing perspectives, life experiences and cultural backgrounds pursue goals with mutual respect and a shared spirit of inquiry.
Required Qualifications
· Bachelor's degree · Bilingual, English and Spanish
Preferred Qualifications
· Prior research experience, specifically research study coordination
Additional Job Information
For more information about the Dao Research Lab, please visit our website at ************************************
$39k-48k yearly est. 60d+ ago
Clinical Coordinator, CoAEMSP
Cataldo Ambulance Business Trust 4.1
Clinical research coordinator job in Malden, MA
Organizes and coordinatesclinical and field opportunities and the hands-on training for students in Paramedic (Advanced) courses. Acting as a liaison between the CEC program, students and clinical sites. Ensures schedule rotations and compliance are maintained, trains preceptors, tracks student progress (competencies, patient hours) evaluates performance and maintains documentation, all while aligning with state/national standards (CoAEMSP) for high quality clinical and field educational experiences.
Primary Accountabilities/Responsibilities
1. Coordinating and managing student progress towards required clinical and field time.
2. Creates mid-term and semester student progress reports.
3. Determine clinical competency based on the position requirements and communicates with the student and Program Director.
4. Regularly meets with students to review progress.
5. Prepares and communicates standard reports regarding student progress to the Dean, Paramedic Program Director and Lead Instructor.
6. Coordinates affiliation agreements between Cataldo Education Center and field and clinical sites.
7. Cultivates, monitors and guides new clinical and field sites for the programs.
8. Routinely visits field and clinical sites, acting as a liaison between the program, students and clinical sites (hospitals, clinics, etc.) to schedule rotations, ensure compliance, train preceptors.
9. Monitors students at clinical and field sites, collecting feedback and assessing effectiveness.
10. Makes recommendations regarding students' skills and status to determine competency.
11. Collect feedback from participants, FTO's and clinical sites to assess effectiveness and impact pf educational programs.
12. Provides leadership and mentoring to ensure quality patient care and a positive work environment.
13. Providing coaching, feedback, and professional development opportunities to the cohort to enhance skills and promote growth.
14. Creates an inclusive, collaborative and supportive team culture that promotes engagement, accountability and continuous learning.
15. Ensures the program is in compliance with clinical and field site and regulatory requirements.
16. Provides preceptor training to field and clinical sites as needed.
17. Manages Platinum Tracker and assists students as needed.
18. Knowledgeable of CoAEMSP standards and provides documentation clinical and field compliance.
19. Serves as a member of the Education Advisory Committee.
20. Attend faculty meetings, training and planning sessions.
21. Maintains knowledge of and complies with all company policies, procedures, and guidelines at all times.
22. Completes other duties as requested and assigned.
Education and Experience:
High School Diploma or Equivalent Must be 18 years of age or older Ability to meet the essential duties and physical, mental and sensory requirements of the position at all times.
Satisfactory background check and MA CORI (Criminal Offender Record Information), verification required annually. Verification of an acceptable motor vehicle driving record, verification required annually.
National Registry Paramedic Certification, current working Massachusetts Paramedic License. Valid driver's license.
Preferred: Instructor Certification in ACLS, PALS, PEPP, CPR, PHTLS, AMLS, GEMS, EPC, and Current State of Massachusetts Instructor/Coordinator license(s)
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is frequently required to sit; talk or hear; stand; walk; use fingers, hands and arms to reach, handle or operate basic office equipment, objects, tools or controls. The employee is occasionally required to climb or balance; stoop, kneel, crouch or crawl; taste or smell. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
$54k-72k yearly est. Auto-Apply 9d ago
Clinical Research Associate
CTTX Health
Clinical research coordinator job in Cambridge, MA
Are you passionate about clinicalresearch and ready to make an impact on patients' lives? We're looking for a ClinicalResearch Associate (CRA) to join a fast-growing biotech company (confidential) that's advancing innovative therapies in neuroscience.
What You'll Do:
Conduct site initiation, monitoring, and close-out visits to ensure trials meet the highest quality standards.
Review and verify study data for accuracy and completeness.
Collaborate with site staff and cross-functional teams to solve challenges and keep trials on track.
Identify and escalate any protocol deviations, safety concerns, or data issues.
Requirements
What We're Looking For:
Bachelor's in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus).
3+ years of CRA or site monitoring experience.
Strong knowledge of ICH-GCP and FDA regulations.
Excellent communication, organization, and problem-solving skills.
Willingness to travel as needed (up to 50-75%).
Extra Credit:
Experience with CNS or rare-disease trials.
Benefits
Amazing benefits package starting day one!
$60k-92k yearly est. Auto-Apply 60d+ ago
Learn more about clinical research coordinator jobs
How much does a clinical research coordinator earn in Manchester, NH?
The average clinical research coordinator in Manchester, NH earns between $40,000 and $83,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.
Average clinical research coordinator salary in Manchester, NH