Clinical Coordinator - Main Operating Room
Clinical research coordinator job in Boston, MA
We are seeking a Clinical Coordinator to join the team within our Main Operating Room in Boston. Key Responsibilities:
Leading, mentoring, and developing a high-performing team to ensure quality patient care and a positive work environment.
Providing coaching, feedback, and professional development opportunities to team members to enhance staff skills and career growth.
Creating an inclusive, collaborative, and supportive team culture that promotes engagement, accountability, and continuous learning.
Overseeing daily clinical and administrative operations, including staff scheduling, resource allocation, and facilitating coordination of care/service.
Developing, recommending, and implementing internal standards, policies, and procedures to improve quality and cost-effectiveness of patient care.
Selecting, supervising, and evaluating nursing and clinical support personnel to develop and provide staff education/development programs.
Leading and participating in hospital, departmental, and multidisciplinary programs, committees, and special projects.
Collaborating seamlessly across disciplines, working closely with each member of the team.
Minimum Qualifications
Education:
A Bachelor of Science in Nursing.
Master's Degree in Nursing preferred.
Experience:
A minimum of 4 years of Operating Room experience as an RN.
Pediatric Operating Room RN experience preferred.
Licensure/ Certifications:
Current Massachusetts license as a Registered Nurse RN
*$20,000 sign-on for RNs with over 2 years of OR experience who have not worked at BCH in 2+ years*
*This position is eligible for a $10,000 Employee Referral Bonus for internal employees*
*Additional $8/hour incentive for all hours worked after orientation is completed*
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.
Senior Global Clinical Trial Manager (Waltham, MA)
Clinical research coordinator job in Waltham, MA
ICON has opened a Senior Global Clinical Trial Manager position, and I wanted to see if you are interested.
This position will be, direct hire with full benefits, 3 days in the office (900 Winter St, Waltham, MA 02451) with 2 days remote from home, with pay up to $155k (No bonus)
Please let me know if you are interested in finding out more about this opportunity?
Senior Global Clinical Trial Manager
What you will be doing:
Clinical Trial Management with, deliverable, budget, vendor management, along with vendor and site oversite and training.
Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation.
Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight.
Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance.
Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines.
Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary.
Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams.
Your profile:
Currently, or recently, working at a CRO, Pharmaceutical or Biotechnology company.
A minimum of 4+ years of experience in a Global Clinical Trial Management position at a CRO or Pharmaceutical Organization.
Clinical Trial Management experience including trial deliverable, trial budget, vendor management, along with vendor and site oversite and training.
Experience as a Clinical Trial Manager running Phase 1 trials
Bachelor's degree in health, life sciences, or other relevant fields of study.
At least 10+ years of relevant clinical experience
Preferred: 2+ years of monitoring experience.
Experience in managing complex or global trials is advantageous.
Experience in managing trial components from start-up to database lock.
Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives.
Clinical Research Associate
Clinical research coordinator job in Boston, MA
MDC Associates ("MDC") is a full-service CRO dedicated to supporting innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world. Initially founded to provide Regulatory and Quality guidance, we identified a need for highly skilled Clinical Affairs, Clinical Operations, and Data Management services and built our CRO to best ensure our client's success. We're proud of our 35+ year track record providing guidance and resources that have helped to deliver next-generation advances in microbiology, clinical chemistry, infectious disease and companion diagnostics (CDx) that contribute to a healthier world.
The Clinical Research Associate is highly motivated and organized individual with a proven history executing IVD clinical studies. The CRA will be tasked to conduct site qualification, site initiation, interim monitoring and close out visits to clinical sites. The ideal candidate will have a keen understanding of the nuances of IVD clinical studies and will conduct all clinical trials in accordance with Good Clinical Practices and study protocol requirements.
Primary Responsibilities
Develop and conduct site training on protocol requirements, source documentation completion, and electronic data capture (EDC).
Conduct regular site monitoring visits (virtually and physically) and prepare reports for study initiation, monitoring, and close-out visits.
Ensure site adherence to study protocols and regulatory requirements.
Draft and/or provide input into Clinical Study Protocols, supporting plans and procedures, including Informed Consent Forms (ICFs), Monitoring Plans and Data Collection Forms in conjunction with the assigned Project Team.
Assist with Institutional Review Board (IRB) management.
Manage study budget and agreements with study sites.
Manage study Trial Master Files.
Serve as primary point of contact with study sites.
Monitor and analyze clinical study data and report on performance to the project team.
Assist with the development of study databases for managing clinical data.
Qualifications
BA, BS, or Master's degree in Life Sciences, Data Science, Statistics, or a related field (preferred).
2+ years' relevant clinical study experience in the medical devices industry or pharmaceuticals industry with specific experience in in vitro diagnostic devices a plus.
ACRP or similar certification a plus but not required.
Knowledge and Skills
In depth knowledge of, and experience in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and HIPAA guidelines.
Understanding of U.S. Food and Drug Administration (FDA) laws and guidance pertaining to clinical studies.
Understanding of IRB guidelines and Common Rule.
Ability to learn applicable protocol requirements as provided in company training.
Computer skills including proficiency in use of Office 365, Microsoft Word, Excel, Access, Outlook and PowerPoint.
Strong written and verbal communication skills including good command of English language.
Excellent organizational and problem-solving skills.
Effective time management skills.
Attention to detail and accuracy in work.
Ability to manage competing priorities without compromising quality.
Ability to establish and maintain effective collaborative relationships with coworkers, managers and clients.
Travel Requirements
Up to 75% travel including local, within U.S and outside of the US. Travel may include:
Attending clinical site Initiation, interim and close out monitoring visits
Attending annual industry conferences (i.e.: Association of Clinical Research Professionals)
Pay
Compensation commensurate with experience.
Employee Stock Options
Benefits
Medical, Dental, and Vision Insurance.
Health Reimbursement Account (HRA)
Flexible Spending (FSA) / Dependent Care Accounts (DCA)
Short and Long-Term Disability
Group Term Life Insurance
401(k) with Safe Harbor Match
Unlimited PTO
Paid Holidays
Equal Opportunity Employer
MDC is an Equal Opportunity Employer committed to a diverse workforce. MDC will not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, or membership in any other category protected under law.
Clinical Trial Manager
Clinical research coordinator job in Waltham, MA
**Our client cannot currently sponsor a visa candidate (must be US Citizen or Green Card Permanent Resident)**
Hybrid Details: 3 days/week onsite
Duration: 6 months to start
Description
The clinical operations in the Department of Early Clinical Stage Development plays a central role in the Phase 1 clinical development. He/She will lead operations across all future clinical sites to ensure operational and the organization's objectives are met. The candidate will provide clinical operations strategy, planning, initiation, and execution of clinical trials, including vendor selection, contracts and budgets, vendor oversight and management, and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance.
Role and Responsibilities
Responsible for developing strategy, and methodology of clinical operations programs.
Responsible to ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready.
Ensures excellence, planning, oversight, and delivery of clinical programs/trials prior to Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset in a priority disease area with focus on speed and value as Medicine Excellence goals.
Oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines.
Provide operational and strategic input on training materials, program specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers).
Ensures timely execution excellence input into various documents, incl asset evidence plan and clinical trial protocols.
Responsible for collaborating with Clinical Trial Supply Unit in determining a comparator sourcing strategy if applicable.
Drive site selection and subject recruitment programs to deliver study enrollment targets.
Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors.
Participates in SOP development, process mapping, training of CTAs, and other departmental activities.
Partner and liaise with internal team members across the globe, which includes: technical leads in multiple functional areas, project management, and regulatory affairs
Minimum Education & Experience Requirements:
M.S or Ph.D in basic sciences with 10+ years' experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO.
Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality.
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
Experience leading global trials outside the US/UE/ASIA/Americas is preferred.
Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management.
Demonstrated experience in successful planning and implementation of clinical trial operations.
Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance.
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
Clinical Trial Manager, Phase 1 Studies
Clinical research coordinator job in Waltham, MA
Clinical Trial Manager - Phase 1 Studies
Contract Role
Our client's Early Clinical Stage Development team is seeking an experienced Clinical Trial Manager (CTM) to lead Phase 1 clinical trial operations. This role plays a central part in advancing early-stage clinical programs and ensuring high-quality, inspection-ready execution across all clinical sites. The CTM will provide end-to-end operational leadership, including strategy development, trial planning, vendor oversight, budget management, and proactive risk mitigation to ensure on-time, compliant delivery of Phase 1 studies.
Key Responsibilities
Develop and implement strategy, methodology, and operational plans for clinical programs.
Ensure all clinical trials are conducted in full compliance with regulatory requirements and are consistently inspection-ready.
Lead the planning, oversight, and execution of Phase 1 studies-from Start of Development through Proof of Clinical Concept.
Manage trial budgets, timelines, and operational deliverables in accordance with ICH-GCP and applicable global regulations.
Provide operational and strategic input on training materials, program standards, clinical development plans, and regulatory documents (e.g., Investigator Brochure, CSR, safety updates, briefing books, submission content).
Drive execution excellence and contribute to trial protocols, asset evidence plans, and other development documents.
Collaborate with the Clinical Trial Supply Unit to determine comparator sourcing strategies as needed.
Lead site selection, startup activities, and recruitment strategies to meet enrollment goals.
Participate in database setup, UAT testing, and development of monitoring guidelines, edit checks, and data cleaning workflows.
Support departmental activities including SOP development, process mapping, and training of Clinical Trial Assistants.
Serve as a key liaison with global cross-functional stakeholders including project management, regulatory affairs, and technical function leads.
Minimum Qualifications
M.S. or Ph.D. in a scientific discipline with 10+ years of Clinical Operations experience in biotech, pharma, or CRO environments.
Strong ability to identify and champion process improvements focused on efficiency, reliability, cost, and quality.
In-depth knowledge of FDA/EMEA regulations, ICH guidelines, and GCP requirements.
Experience leading global clinical trials; international trial oversight experience preferred.
Advanced expertise in patient recruitment, compliance management, safety oversight, document control, investigational product management, and budget administration.
Demonstrated success in planning and executing clinical trial operations across all phases.
Experience developing protocols, SOPs, CSRs, and regulatory-supporting documentation for NDAs.
Proven track record of driving business process transformation and leading cross-functional teams toward complex deliverables.
Clinical Trial Manager
Clinical research coordinator job in Waltham, MA
Lead operations across clinical sites to meet trial objectives.
Develop strategy and methodology for clinical operations programs.
Ensure clinical trials comply with regulatory requirements and are inspection-ready.
Plan, oversee, and deliver clinical programs from development to proof of concept.
Manage budgets and timelines in accordance with regional regulations and ICH-GCP guidelines.
Provide operational and strategic input on training materials and development plans.
Oversee vendor selection and ensure effective vendor management.
Identify and manage risks to ensure high-quality trial delivery.
Ensure investigational product oversight and document management.
Lead patient recruitment efforts and ensure safety compliance.
Clinical Research Coordinator
Clinical research coordinator job in Nashua, NH
UpTrials is a new platform that helps professionals like yourself get hired faster for relevant clinical research roles. We are partnered with an organization seeking a Clinical Research Coordinator II to join our team onsite in Boston, Massachusetts! To be considered for this and other roles, please create a profile at app.uptrials.com
Job Title: Clinical Research Coordinator II
Location: Nashua, NH
Overview:
Our site partner is actively seeking a qualified and driven Clinical Research Coordinator II to support and manage clinical trials across multiple sites. This role requires a hands-on, adaptable professional with strong clinical research experience, especially in the management of all aspects of trial operations and stakeholders, including PIs, patients, and sponsor/CRO representatives. The position will involve regular travel between our partners locations and satellite sites within the company.
Key Responsibilities:
Coordinate day-to-day activities for clinical research studies across various therapeutic areas (including, but not limited to, ophthalmology, dermatology, pulmonology), and at both at HQ and satellite site locations
Perform direct patient-facing duties, including informed consent, visit scheduling, and follow-up
Manage all aspects of patient recruitment and enrollment across studies, including database reviews, outreach, pre-screening, and communications
Confidently perform blood draws and handle biospecimen processing and shipping in accordance with protocol requirements
Maintain and manage study documentation, source data, and regulatory binders across numerous systems, including our partner's CTMS, sponsor EDC systems, and more
Support monitoring visits and participate in both internal and external audits
Communicate effectively with sponsors, CROs, investigators, and internal departments
Provide general support to the team and step in across functions as needed to meet study goals
Required Qualifications:
Minimum 3 years of direct clinical research experience for industry-sponsored, interventional clinical trials for investigational drugs
Ability to communicate strongly with patients and gain their trust in efforts to recruit and retain participants throughout the entirety of a study
Proficiency in patient care, recruitment, lab specimen handling, monitoring, and auditing
Excellent multitasking, time management, and organizational abilities
Willingness and ability to travel regularly (up to 50%) across sites Preferred
Qualifications:
Phlebotomy license or willingness to complete phlebotomy course and obtain licensure
Fluent in Spanish (spoken and written)
Prior experience with multi-site clinical trials or decentralized trial models
Familiarity with clinical trial management systems (CTMS) and electronic regulatory platforms
Background in therapeutic areas such as Ophthalmology, Dermatology, or Pulmonology
Flexibility, initiative, and a team-oriented mindset are essential
Candidates must be comfortable working in a fast-paced, high-accountability environment
We believe that the unique contributions of all our site partner's employees are the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.
Clinic Coordinator - (Mon-Fri 11:30am-8pm)
Clinical research coordinator job in Boston, MA
Clinic Coordinator
Location:450 Brookline Ave, Boston, MA 02215 Category:Administration Support/Customer Service Employment Type:full time
Clinic Coordinators demonstrate the values and mission of Dana-Farber everyday by providing expert compassionate care to our patients with cancer.
Responsibilities:
Create an exceptional patient experience by delivering outstanding customer service throughout the check in and check out process.
Manage complex scheduling to meet patient needs.
Act as a liaison for patients, families and providers.
Respond to emergent and compliance matters with creative problem solving and critical thinking.
Qualifications
Bachelor's degree preferred.
0 - 1 year experience in a customer service setting.
Proficiency in technology and complex computer systems required.
Ability to work in a fast paced and complex clinical environment.
Professional Growth:
The Clinic Coordinator position may lead to career opportunities in administrative, team lead, and management roles. Dana-Farber is committed to offering a variety of personal, professional, and leadership development opportunities to all members of its workforce to meet the everchanging needs of our workforce and our industry.
Well-Being and Benefits
Health, Dental and Vision Insurance
Time Off
Family & Child Care Benefits and Resources
Retirement Programs
Life Insurance
Short Term Disability
Health Savings Account
Flexible Spending Account
Transportation
LGBTQ+
Our Benefits Partners Include:
Harvard Pilgram Health Care
Delta Dental
Eye Med
Fidelity Investments
Sentinel Benefits Group
Prudential
Voya Financial
TIAA
Care.com
Edukate
Headspace
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 equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Join Our Talent Network
Stay connected with Dana-Farber and receive alerts with new job opportunities and news relative to your interests.
Senior Clinical Research Coordinator
Clinical research coordinator job in Boston, MA
Site: The Brigham and Women's Hospital, Inc.
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.
to support new cardiovascular clinical trials
Job Summary
The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.
Responsibilities: Ongoing support of TIMI investigators with all phases of clinical research to include: Trial Initiation; Trial Coordination/Implementation/Maintenance and Trial Close-out.
Trial Initiation: Assist in development of trial protocol IRB application and submit to appropriate authority; prepare and/or review budgets, as required; coordinate and work with ancillary departments/services as needed to successfully execute protocol elements; develop plan for site initiation once IRB protocol approval is received.
Trial Coordination/Implementation: Conduct medical record screening of BWH cardiovascular in-patients and out-patients to identify eligible potential trial subjects; be prepared to approach potential subjects, and/or family members with trial specific information for review/consideration; assist in the recruitment of qualified/interested trial participants; maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow-up trial visits; obtain and process biological samples according to protocol (after completing any necessary training); co-manage with pharmacy all trial medications, including receipt and delivery of same; perform data entry for trials using both manual and electronic data capture; submit all study documentation in a timely manner to appropriate data management and core laboratories; submit any amendments to protocol, or informed consent form(s), to the IRB for review & approval; notify sponsors and IRB of all pertinent AEs (Adverse Events) and SAEs (Severe Adverse Events); perform other procedures related to the trial protocol; review completeness and quality of data with trial monitors; apprise the Principal Investigator and co-investigator(s) on a daily basis, as needed, of overall trial progress to include: subject enrollment, subject scheduling, issues/problems as they develop, subject retention and lost to follow-up metrics. Also, submit/track/amend annual protocol Continuing Reviews to the IRB; serve as an informed resource for trial participants and their families; educate ancillary staff and departments regarding trial protocols: develop trial materials as needed; and orient and train new staff.
Trial Close-out: Assist with preparation and submission of final trial report to the IRB for review. Prepare all documents/files/binders/electronic data for sponsor-initiated or FDA audits.
Other: Maintain department service standards as outlined in the BWH Code of Conduct. Perform other duties as required.
Qualifications - External
1. Bachelor's Degree
2. Three to five years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred
3. Knowledge of federal and institutional policies governing human clinical research
4. Proficiency with PCs and windows-based software, including Word, Excel and data management system
• Be fluent in English and Spanish (preferred)
• Excellent interpersonal skills and ability to work effectively in team environments.
• Strong organizational skills with ability to multi-task
• Possess good judgment skills with ability to interpret information and protocol requirements, and initiate appropriate actions
• Superior written and oral communication skills, to enable working with individuals from various fields of expertise and with trial subjects from various educational/cultural backgrounds
• Accomplished documentation skills with meticulous attention to detail
• Ability to complete tasks with aggressive deadlines and competing priorities
• Ability to safeguard confidential information.
• Comfortable with hospital in-patient and out-patient environments
EEO Statement
Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills, perspectives and ideas, we choose
to lead. 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.
Qualifications
Education
Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
Yes
Licenses and Credentials
Experience
Clinical Research or Compliance experience 3-5 years required
Knowledge, Skills and Abilities
- Exceptional time management and organization skills.
- Excellent written and verbal communication skills.
- Knowledge of current and developing clinical research trends.
- Sound interpersonal skills and the ability to mentor others.
- Ability to identify problems and develop solutions.
- Demonstrated ability to successfully manage multiple projects.
Additional Job Details (if applicable)
Remote Type
Onsite
Work Location
350 Longwood Avenue
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$49,504.00 - $72,404.80/Annual
Grade
6
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:
The Brigham and Women's Hospital, Inc. 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.
Auto-ApplyClinical Research Associate - Boston/Northeast
Clinical research coordinator job in Cambridge, MA
Clinical Research Associate - Boston ICON plc is a world-leading healthcare intelligence and clinical research 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 Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research 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 Clinical Research 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
Clinical Research Associate - Boston/Northeast
Clinical research coordinator job in Cambridge, MA
Clinical Research Associate - Boston
ICON plc is a world-leading healthcare intelligence and clinical research 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 Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research 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 Clinical Research 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
Auto-ApplyClinical Research Associate - Boston/Northeast
Clinical research coordinator job in Cambridge, MA
Clinical Research Associate - Boston
ICON plc is a world-leading healthcare intelligence and clinical research 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 Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research 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 Clinical Research 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
Auto-ApplyClinical Research Associate II
Clinical research coordinator job in Boston, MA
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Research Associate
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
Clinical Research Associate needs 2-5 years of clinical research experience in industry settings with a bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field
Clinical Research 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
Clinical Research 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
Senior Clinical Research Coordinator
Clinical research coordinator job in Boston, MA
Site: The Brigham and Women's Hospital, Inc. 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.
to support new cardiovascular clinical trials
Job Summary
The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.
Responsibilities: Ongoing support of TIMI investigators with all phases of clinical research to include: Trial Initiation; Trial Coordination/Implementation/Maintenance and Trial Close-out.
Trial Initiation: Assist in development of trial protocol IRB application and submit to appropriate authority; prepare and/or review budgets, as required; coordinate and work with ancillary departments/services as needed to successfully execute protocol elements; develop plan for site initiation once IRB protocol approval is received.
Trial Coordination/Implementation: Conduct medical record screening of BWH cardiovascular in-patients and out-patients to identify eligible potential trial subjects; be prepared to approach potential subjects, and/or family members with trial specific information for review/consideration; assist in the recruitment of qualified/interested trial participants; maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow-up trial visits; obtain and process biological samples according to protocol (after completing any necessary training); co-manage with pharmacy all trial medications, including receipt and delivery of same; perform data entry for trials using both manual and electronic data capture; submit all study documentation in a timely manner to appropriate data management and core laboratories; submit any amendments to protocol, or informed consent form(s), to the IRB for review & approval; notify sponsors and IRB of all pertinent AEs (Adverse Events) and SAEs (Severe Adverse Events); perform other procedures related to the trial protocol; review completeness and quality of data with trial monitors; apprise the Principal Investigator and co-investigator(s) on a daily basis, as needed, of overall trial progress to include: subject enrollment, subject scheduling, issues/problems as they develop, subject retention and lost to follow-up metrics. Also, submit/track/amend annual protocol Continuing Reviews to the IRB; serve as an informed resource for trial participants and their families; educate ancillary staff and departments regarding trial protocols: develop trial materials as needed; and orient and train new staff.
Trial Close-out: Assist with preparation and submission of final trial report to the IRB for review. Prepare all documents/files/binders/electronic data for sponsor-initiated or FDA audits.
Other: Maintain department service standards as outlined in the BWH Code of Conduct. Perform other duties as required.
Qualifications - External
1. Bachelor's Degree
2. Three to five years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred
3. Knowledge of federal and institutional policies governing human clinical research
4. Proficiency with PCs and windows-based software, including Word, Excel and data management system
* Be fluent in English and Spanish (preferred)
* Excellent interpersonal skills and ability to work effectively in team environments.
* Strong organizational skills with ability to multi-task
* Possess good judgment skills with ability to interpret information and protocol requirements, and initiate appropriate actions
* Superior written and oral communication skills, to enable working with individuals from various fields of expertise and with trial subjects from various educational/cultural backgrounds
* Accomplished documentation skills with meticulous attention to detail
* Ability to complete tasks with aggressive deadlines and competing priorities
* Ability to safeguard confidential information.
* Comfortable with hospital in-patient and out-patient environments
EEO Statement
Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills, perspectives and ideas, we choose
to lead. 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.
Qualifications
Education
Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
Yes
Licenses and Credentials
Experience
Clinical Research or Compliance experience 3-5 years required
Knowledge, Skills and Abilities
* Exceptional time management and organization skills.
* Excellent written and verbal communication skills.
* Knowledge of current and developing clinical research trends.
* Sound interpersonal skills and the ability to mentor others.
* Ability to identify problems and develop solutions.
* Demonstrated ability to successfully manage multiple projects.
Additional Job Details (if applicable)
Remote Type
Onsite
Work Location
350 Longwood Avenue
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$49,504.00 - $72,404.80/Annual
Grade
6
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:
The Brigham and Women's Hospital, Inc. 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.
Auto-ApplyStudy Coordinator (Natick, MA)
Clinical research coordinator job in Natick, MA
Clinical Research 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 clinical research!
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 clinical research.
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.
Senior Clinical Research Coordinator - Per Diem
Clinical research coordinator job in Boston, MA
Under minimal guidance, this position is responsible for oversight of a portfolio of research projects. This position will lead the development and implementation of clinical research projects by collaborating with Principal Investigator and/or designees to ensure targets are met on time. Develop and implement enrollment strategies and study documents including protocol, and study manuals. Provide analytical, data management, and methodological support in the development of clinical research protocols and data management tools. Assist with the development and implementation of best practice guidelines for conducting various clinical research protocols. May train lab staff members and assist in writing articles and papers for submission.
Key Responsibilities:
* In conjunction with the PIs and/or designees designs, develops, and implement clinical research projects such as enrollment strategies, study materials, and study documents.
* Responsible for daily operations of the study. Develops and implements processes and procedures to meet study goals and protocol requirements. Participate in training and prepare study related training materials. Plans and prioritizes the work of administrative and support personnel on all clinical study activities.
* Consents and enrolls patients for research studies by providing detailed information on the Clinical Study to patients and families. Communicates all policies and procedures and responds to all inquiries. Evaluate the suitability of prospective study candidates and make selections based on clinical knowledge of each study. Provide input for updates of SOPs and drafting of new quality documentation.
* Assist with developing and implementing best practice guidelines for conducting various clinical research protocols. Presents and prepares training materials as part of the sponsored educational efforts.
* Provides analytical, data management, and methodological support to PIs in the development of clinical research protocols and data management tools. Manages data for single and/or multi-institutional investigations.
* Develops study specific data management and quality assurance procedures and monitors their implementation at site visits and/or periodic review of study data management reports.
* Works with PIs and lab members to plan analyses, clean and verify data and facilitate preparation of datasets for analyses.
* May assist in writing grants. Prepare new applications for research funding and implementing and managing ancillary study grants.
Minimum Qualifications
Education:
* A Bachelor's Degree is required, Master's Degree preferred.
Experience:
* Bachelor's Degree with 4 years of relevant work experience; OR Master's Degree and 2 years of relevant work experience is required.
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.
Senior Global Clinical Trial Manager for the Waltham, MA office.
Clinical research coordinator job in Boston, MA
ICON is seeking Senior Global Clinical Trial Manager for the Waltham, MA office. Pay up to $170k (No bonus)
As the Senior Global Clinical Trial Manager, will be responsible for Running global clinical trials, trial deliverable, trial budget, trial vendors, CRA and Site operational oversite and training. Following monitoring plans and reviewing trip reports.
This position will be, direct hire with full benefits, 3 days in the office (900 Winter St, Waltham, MA 02451) with 2 days remote from home, with pay up to $170k (No bonus)
Please let me know if you are interested in finding out more about this opportunity?
Senior Global Clinical Trial Manager (ICON embedded with Alkermes)
What you will be doing:
Clinical Trial Management with, deliverable, budget, vendor management, along with vendor and site oversite and training.
Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation.
Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight.
Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance.
Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines.
Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary.
Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams.
Your profile:
Currently, or recently, working at a CRO, Pharmaceutical or Biotechnology company.
A minimum of 4+ years of experience in a Global Clinical Trial Management position at a CRO or Pharmaceutical Organization.
Clinical Trial Management experience including trial deliverable, trial budget, vendor management, along with vendor and site oversite and training.
Experience as a Clinical Trial Manager running Phase 1 trials
Bachelor's degree in health, life sciences, or other relevant fields of study.
At least 10+ years of relevant clinical experience
Preferred: 2+ years of monitoring experience.
Experience in managing complex or global trials is advantageous.
Experience in managing trial components from start-up to database lock.
Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives.
Senior Clinical Research Coordinator
Clinical research coordinator job in Boston, 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.
Job Summary
The MGH CORE Program is seeking a full-time Senior Clinical Research Coordinator (CRC-Senior) to join our multidisciplinary team. This position offers the opportunity to take on a leadership role in advancing innovative supportive care research in oncology and palliative care. The MGH CORE Program brings together oncologists, palliative care specialists, psychiatrists, psychologists, nurses, and other allied clinician researchers dedicated to improving the quality of care and outcomes for patients and families facing cancer and serious illness.
Senior Clinical Research Coordinator (CRC)
The CRC-Senior will oversee program-wide regulatory and operational needs across multiple supportive care research studies. In addition to contributing to projects employing qualitative methods, survey data, and clinical trial designs, the CRC-Senior will help develop and implement standard operating procedures, onboard and train junior clinical research coordinators (CRCs), and ensure high-quality study execution and compliance. This position is ideal for candidates with prior research experience who are ready to take on supervisory and program development responsibilities.
Qualifications
Key ResponsibilitiesLeadership & Training
Train, and mentor entry-level CRCs, ensuring adherence to standard operating procedures and best practices.
Assist CORE faculty investigators with allocating workload and providing ongoing feedback.
Study Coordination
Provide an extra layer of support in managing CORE studies, including participant eligibility reviews, recruitment, informed consent, and coordination of study visits.
Assist with data collection (surveys, interviews, chart reviews) and quality control checks, using REDCap (Research Electronic Data Capture) or other programs.
Regulatory & Compliance
Prepare and maintain Institutional Review Board (IRB) protocol submissions, amendments, continuing reviews, and adverse event reports.
Ensure compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies.
Program Development
Assist in developing standard operating procedures and quality assurance systems.
Contribute to creation of study templates and guidance for protocol design, database management, and grant submissions.
Qualifications
Education & Experience
Bachelor's degree required (health sciences, psychology, public health, nursing, or related field preferred)
Minimum of 2-5 years of post-baccalaureate research experience in clinical trials or human subjects research, including direct experience with IRB/regulatory documentation.
Skills & Competencies
Ability to oversee, train and evaluate others effectively.
Strong organizational, time management, and problem-solving skills.
Excellent interpersonal and written/verbal communication skills.
Ability to work independently and collaboratively across multiple investigators and teams.
Familiarity with REDCap and other data capture systems preferred.
Application Instructions
Please submit your resume and a cover letter (maximum 300 words) describing your background, interest in supportive care research, and what makes you a strong candidate for this leadership role. We value team members from diverse backgrounds and encourage applicants to share in their cover letter how their unique experiences, perspectives, or interests would contribute to our program's mission.
Additional Job Details (if applicable)
Remote Type
Onsite
Work Location
125 Nashua Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$49,504.00 - $72,404.80/Annual
Grade
6
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:
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.
Auto-ApplyPre-Clinical Research Scientist
Clinical research coordinator job in Boston, MA
Dana-Farber Cancer Institute (DFCI) is seeking a highly motivated Pre-Clinical Scientist to support the research activities at the Experimental Therapeutics (ETx) Core and the Lurie Family Imaging Center (LFIC). The ETx Core and LFIC are co-located in a state-of-the-art 14,000 square-foot preclinical facility, fully equipped with housing and procedure rooms, as well as a suite of in vivo imaging scanners. The Pre-Clinical Scientist will integrate with a highly skilled team of Scientists and Research Associates, and report directly to the Director. The in vivo studies conducted at the facility are focused on cancer research, with an emphasis on in vivo pharmacology, the assessment of novel cancer therapeutics, and multimodality imaging of cancer, and provide key information for the improvement of cancer patient treatment and care.
The position is at 27 Dry Dock Ave, South Boston
******************************
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.
Responsibilities
The successful candidate will work collaboratively and in concert with a staff of dedicated scientists, animal/imaging technologists/associates, administrative personnel, and clinical counterparts to design and execute oncology related mouse studies using various imaging modalities (BLI/MRI/SPECT/PET/CT, etc) as well as the entire spectrum of conventional (e.g., caliper measurements, clinical scoring) endpoints to evaluate pre-clinical novel cancer therapies. The Pre-Clinical Scientist will work closely with the Director to execute the vision and strategic direction of translational cancer research. The Pre-Clinical Scientist will partner with clinical affiliates to facilitate bidirectional translational cancer science. The Pre-Clinical Scientist will work closely with other Centers and Departments at Dana-Farber that are engaged in research on small animal modeling in cancer and in experimental therapeutics. The Scientist will be expected to develop research projects for presentation at national meetings and publication in peer-reviewed journals. The Pre-Clinical Scientist will build collaborations with principal investigators, other departments, and industrial partners to design experimental therapeutics studies, and will be responsible for the execution, analysis and generation of reports for studies.
Skills and Abilities Required
* Hands-on experience using various cell line and PDX mouse/rat models and orthotopic models to execute in vivo workflows is highly desired.
* Familiar with IVIS, PET/CT, MRI and other imaging approaches.
* Demonstrated ability to deploy novel in vivo models to enable drug discovery and translational research.
* Excellent interpersonal and communication skills with the ability to interact effectively with internal and external collaborators.
* Demonstrated expertise in various in vitro methodologies such as immune profiling by flow cytometry, ELISA and Western blot analysis.
* Ability to establish independent research and secure external funding
* Full-time, M-F; hours may vary with project needs
Dana-Farber Cancer Institute supports a robust Scientist career track with multiple opportunities for advancement, leadership, and recognition. The successful candidate will be appointed to a level within the Scientist career track commensurate with his or her accomplishments and abilities. Promotion on this track will be based on achievement of goals.
Qualifications
* PhD cancer biology, biology or relevant biological sciences
* Minimum of 5 years' experience in pre-clinical pharmacology pre- or post-PhD
* Established track record of research publications, preferably in cancer research
* Builds productive internal/external working relationships.
* Having wide-ranging experience, uses technical concepts and Institute objectives to resolve complex issues in creative and effective ways.
* Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
* Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
* Networks with key contacts outside our own area of expertise.
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)
$80,000 - $82,900
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 equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse 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.
EEOC Poster
Auto-Apply