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.
Clinical Research Associate- Vaccines
Clinical research coordinator job in Boston, MA
**Phase I vaccine experience preferred**
** fast paced studies**
** 10 site visits a month**
The Senior CRA will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Responsibilities:
Applies knowledge of ICON's policies and procedures
Demonstrates excellent written and oral communication
Demonstrates excellent knowledge of ICH/GCP
Displays ability to manage investigative sites to facilitate trial deliverables
Demonstrates ability to escalate issues appropriately
Conducts monitoring to confirm subject safety and data integrity
Describes and demonstrates the principals of IP accountability
Identifies scientific misconduct at the site level
Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
Mentors CRAs new to the position or company
Serves as an observation visit leader
Conducts monitoring evaluation visits
Assists team lead in the development of trial tools or documents
Assists with CTM tasks
Participates in the development of process changes/improvements
Presents at client meetings/Investigator meetings
Provides training to trial teams
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.
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 (Pharma)
Clinical research coordinator job in Waltham, MA
The clinical operations in the Department of Early Clinical Stage Development plays a central role in the Phase 1 clinical development at Alkermes. 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.
Required / Desired
5+ years of experience in clinical trials
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 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 Research Coordinator - 248540
Clinical research coordinator job in Woodbury, NY
Job Title: Clinical Research Coordinator
Employment Type: Part-Time (25+ hours/week, with potential for additional hours depending on project needs) - potential to go full time
Compensation: $30-$34 per hour
Practice Setting: Dermatology / Medical Practice
Schedule: On-site, Monday-Friday, 8:00 AM-5:00 PM
About the Role
We are seeking an experienced Clinical Research Coordinator to join our dermatology-focused medical practice. The ideal candidate will play a key role in supporting ongoing clinical trials and ensuring high-quality patient care and data integrity.
Responsibilities
Perform patient vitals and EKGs
Assist with current clinical trials, including patient visits and study procedures
Conduct accurate and timely data entry
Support study documentation and protocol adherence
Coordinate with investigators, study sponsors, and clinical staff
Maintain compliance with regulatory and site requirements
Qualifications
3-4 years of experience as a Clinical Research Coordinator or in a similar clinical research role
Experience in dermatology is preferred
Strong organizational skills and attention to detail
Ability to work effectively in a fast-paced clinical environment
Excellent communication and patient interaction skills
Ability to work on-site throughout the week
Why Join Us?
Opportunity to contribute to impactful dermatology research
Collaborative team environment
Flexible part-time schedule with potential for additional hours
Administrative Researcher
Clinical research coordinator job in New York, NY
Atlantic Group is seeking a detail-oriented and proactive Administrative Researcher to support our Accounting & Finance recruiting team. This role is ideal for someone who enjoys research, organization, and playing a behind-the-scenes role in driving team productivity and accuracy. You'll work closely with recruiters and leadership to manage data integrity, conduct market and candidate research, and assist in daily administrative tasks that help streamline the recruiting process.
Responsibilities:
Conduct research on potential candidates across LinkedIn, internal databases, and industry-specific platforms.
Maintain and update candidate and client records in Bullhorn (our CRM system) to ensure data accuracy.
Support recruiters by building and maintaining targeted candidate lists for ongoing searches.
Assist with tracking candidate pipelines, interview schedules, and submission logs.
Prepare weekly activity reports and dashboards for the team.
Provide ad hoc administrative support, including calendar coordination, database updates, and report generation.
Conduct basic market mapping and research to identify new business prospects and hiring trends.
Collaborate with the recruiting team to identify process improvements and increase workflow efficiency.
Qualifications:
Bachelor's degree required.
Strong attention to detail and organizational skills.
Excellent written and verbal communication.
Proficient with Microsoft Excel, Google Workspace, and LinkedIn.
Interest in recruiting, finance, or business operations.
Positive attitude, curiosity to learn, and a team-oriented mindset.
Physician / Clinical Research / Massachusetts / Permanent / Care Coordinator / Clinician needed for In-Home Job
Clinical research coordinator job in Massachusetts
HealthPlus Staffing is assisting a Behavioral Health group with their search for a full-time Care Coordinator/Clinician to join their team in Springfield, MA. The ideal candidate should have a minimum of 2 year of experience working with children, adolescents and families.
This position leads the Family Team and collaborates closely with the members of the Family Team to engage the family.
The caseload standard is 5 youth/family per 1 FTE.
Responsibilities: Provides high quality services for children/youth and families.
Maintains a caseload of youth by FTE as determined by the program.
Convenes and co-facilitates with family and youth Family Team meetings includingcreation and reviews of the Treatment plan and updates the treatment plan to reflect thechanging needs of the child/youth and family Completes clinical assessment of youth referred.
Participates in Utilization Review with DMHRequirements: Masters degree in Social Work, Psychology, or related Mental Health field.
Must be CANS - MA Certified Minimum of 2 years of clinical experience working with individuals, families, and/or groups.
Experience working with individuals with mental health and/or substance abuse issues.
Knowledge of crisis intervention techniques.
Strong interpersonal, communication, and problem-solving skills.
Ability to work independently and as part of a team.
Benefits: Competitive salary and benefits package.
Flexible schedule.
Sign-on bonus.
Professional development opportunities.
Supportive team environment.
If you are interested in this opportunity, please submit your resume and cover letter to HealthPlus Staffing at or call us at .
We look forward to hearing from you.
Thank you for your interest in this position.
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.
Clinical Research Associate - Boston/Northeast
Clinical research coordinator job in Boston, 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
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 Clinical Research 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 clinical research 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
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
Senior Clinical Research Coordinator
Clinical research coordinator job in Albany, NY
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
In the performance of their respective tasks and duties all employees are expected to conform to the following:
Perform quality work within deadlines with or without direct supervision. • Interact professionally with other employees, customers and suppliers. • Work effectively as a team contributor on all assignments.
Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations.
Position purpose
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Director and Clinical Principal Investigator (PI). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities/Duties/Functions/Tasks:
Communicate study requirements to all individuals involved in the study. • Develop and implement recruitment strategies in accordance with Impact Research and IRB requirements and approvals.
Screen subjects for eligibility using protocol specific inclusion and exclusion criteria. • Entry of participant information and study visit procedures into the Clinical Trial Management System to ensure billing to appropriate funding source.
Maintains adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol and/or Impact ResearchPolicy on Investigational Drug/Device Accountability.
Complete study documentation and maintenance of study files in accordance with sponsor requirements and Impact Research policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
Maintains effective and ongoing communication with sponsor, research participants, Director and PI during the course of the study.
Manage the day to day activities of the study including problem solving, communication and protocol management.
Collects and reports ongoing patient recruitment/ enrollment metrics to Director and PI.
Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer.
Protects the rights and welfare of all human research participants involved in research in accordance with Federal regulations
Cooperates with Impact Research compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.
Other duties as assigned.
Qualifications
Education: High school diploma/GED certificate required. Associates degree from an accredited university preferred.
Experience: Minimum 4 or more years of clinical research experience.
Other Requirements: CRC certification preferred.
Performance Requirements:
Knowledge of grammar, spelling, and punctuation.
Knowledge of purchasing, budgeting, and inventory control.
Skill in taking and transcribing dictation and operating office equipment. • Skill in answering the phone and responding to questions.
Skill in time management, prioritization, and multitasking.
Skill in writing and communicating effectively.
Ability to work under pressure, communicate and present information. • Ability to read, interpret, and apply clinic policies and procedures.
Ability to identify problems, recommend solutions, organize and analyze information. • Ability to multi-task, establish priorities, and coordinate work activities. • Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software.
Must be able to lift up to 25 lbs.
Must be able to travel and MVR
Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.
Work Environment: Position is in a well-lighted medical office environment. Occasional evening and weekend work.
Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Auto-ApplySenior Clinical Research Coordinator
Clinical research coordinator job in Albany, NY
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
In the performance of their respective tasks and duties all employees are expected to conform to the following:
* Perform quality work within deadlines with or without direct supervision. • Interact professionally with other employees, customers and suppliers. • Work effectively as a team contributor on all assignments.
* Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations.
Position purpose
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Director and Clinical Principal Investigator (PI). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities/Duties/Functions/Tasks:
* Communicate study requirements to all individuals involved in the study. • Develop and implement recruitment strategies in accordance with Impact Research and IRB requirements and approvals.
* Screen subjects for eligibility using protocol specific inclusion and exclusion criteria. • Entry of participant information and study visit procedures into the Clinical Trial Management System to ensure billing to appropriate funding source.
* Maintains adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol and/or Impact ResearchPolicy on Investigational Drug/Device Accountability.
* Complete study documentation and maintenance of study files in accordance with sponsor requirements and Impact Research policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
* Maintains effective and ongoing communication with sponsor, research participants, Director and PI during the course of the study.
* Manage the day to day activities of the study including problem solving, communication and protocol management.
* Collects and reports ongoing patient recruitment/ enrollment metrics to Director and PI.
* Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer.
* Protects the rights and welfare of all human research participants involved in research in accordance with Federal regulations
* Cooperates with Impact Research compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.
* Other duties as assigned.
Qualifications
Education: High school diploma/GED certificate required. Associates degree from an accredited university preferred.
Experience: Minimum 4 or more years of clinical research experience.
Other Requirements: CRC certification preferred.
Performance Requirements:
* Knowledge of grammar, spelling, and punctuation.
* Knowledge of purchasing, budgeting, and inventory control.
* Skill in taking and transcribing dictation and operating office equipment. • Skill in answering the phone and responding to questions.
* Skill in time management, prioritization, and multitasking.
* Skill in writing and communicating effectively.
* Ability to work under pressure, communicate and present information. • Ability to read, interpret, and apply clinic policies and procedures.
* Ability to identify problems, recommend solutions, organize and analyze information. • Ability to multi-task, establish priorities, and coordinate work activities. • Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software.
* Must be able to lift up to 25 lbs.
* Must be able to travel and MVR
Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.
Work Environment: Position is in a well-lighted medical office environment. Occasional evening and weekend work.
Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Auto-ApplyClinical Research Scientist - Complaint Investigator
Clinical research coordinator job in Valhalla, NY
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people.
At Ascensia, our values serve as the bedrock of our organization. They guide our decisions, actions, and interactions, shaping the culture we collectively foster.
Our Values include:
Resilient Growth Mindset
Executional Excellence
Courageous Leadership
Inclusive Collaboration
We believe that when we live our values authentically, both individually and as a team, we unlock our true potential and drive sustainable success.
POSITION PURPOSE:
Under the supervision of the Internal Clinical Trials (ICT) manager, this position will plan and perform laboratory experiments and internal clinical studies to develop new products and support existing products in the Ascensia Diabetes Care portfolio. Expertise will be provided not only for new product development, but also for external publication, regulatory submissions, and sustaining products in the commercial phase. This position will also provide support to Global Event Management (GEM) laboratory testing needs, including management of customer complaint databases.
What you will be doing:
Conduct internal clinical studies across all phases of new product development and sustainment, including frequent subject sampling via fingerstick and venipuncture.
Support project teams with exploratory and feasibility testing.
Perform experiments using both contrived and native human blood samples, ensuring all procedures and results are accurately documented.
Analyze, interpret, and report testing results clearly and concisely, providing logical recommendations for next steps.
Serve as the primary analyst for blood glucose investigations requiring fresh donor blood, including receipt, logging, and laboratory evaluation of returned products.
Manage the customer complaint database by creating, reviewing, and authoring test instructions for complaint evaluations.
Operate and maintain laboratory equipment, including clinical reference instrumentation, ensuring ongoing compliance with maintenance and audit requirements.
Adhere to Good Clinical Practice (GCP) principles at all times.
Collaborate professionally with scientific colleagues to stay informed of relevant research and company initiatives.
Protect the confidentiality of participant health information.
Perform administrative duties as needed, including report filing, invoice submission, and coordination of biohazard waste disposal.
What you need for success:
Bachelor's degree (BS or BS in Medical Laboratory Science) with a minimum of 4 years of relevant experience, or a Master's degree (MS) with at least 2 years of relevant experience.
Phlebotomy experience required; certification preferred.
Experience in the medical device or pharmaceutical industry preferred.
Strong oral and written communication skills in English required.
Demonstrated ability to collaborate effectively within multidisciplinary scientific teams.
Proven competency in experimental design, execution, and data interpretation.
TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.
Auto-ApplySenior 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.
Director, Clinical Research Scientist
Clinical research coordinator job in Day, NY
Cellectis' Clinical Sciences (CS) organization is seeking a highly motivated and experienced clinical Research Scientist to support the both the development and execution of our innovative proprietary UCART allogeneic CART cell therapies programs. The Director, Clinical Research Scientist participates in design and implementation of the development strategy and supports the Clinical Science Physicians with various deliverables necessary for effective and efficient planning and execution of their assigned program. Additionally, the successful candidate in this role would also be responsible for working closely with the Clinical Operations Team to support the development of clinical development processes, templates and potentially training and management of junior clinical research scientists.
Job Responsibilities
* Supports the clinical development of assigned programs and participates and supports the design and implementation of the development strategy
* Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA)
* The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience
* May co-lead study team meetings in partnership with Clinical Operations study lead
* Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums, act as primary point-of-contact for clinical study or program for clinical science related activities, and providing clinical science inputs into study safety reporting.
* Clinical Scientists are likely to have regular external interactions with a variety of internal and external partners and stakeholders, such as cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups. They may also, alongside the Clinical Sciences Physician, participate in external interactions with health authorities (HAs)
* Provides strategic clinical science support for assigned studies and programs
* Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
* May author and/or review clinical narratives in conjunction with pharmacovigilance
* in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
* Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion in concert with Clinical Science Physicians
* In concert with Clinical Sciences Physicians provide clinical contributions to internal documents and presentations including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts)
* As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
* Where applicable, may manage one or more direct reports and is, in such instances responsible for hiring, training, developing, and retaining talent on his/her staff.
* As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
* Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
Core Competencies
* Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally
* Outstanding written communication skills
* Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points
* Comfortable working in fast paced entrepreneurial environment
* Ability to travel up to 20%
Education and Experience
* Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred)
* Minimum of 5 years pharma/biotech industry experience in clinical development in oncology/hematology clinical trials
* experience in CAR T-cell therapy is preferred
* Experience in data review, data cleaning, managing and interpreting clinical trials results as well as exposure to writing protocols
* Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
Physical Requirements
* In office 4 days per week, required
* Sedentary, desk position
Salary Range
* $175,000-225,000 (final salary is dependent on candidate's experience and credentials)
Auto-ApplySenior 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.