Clinical research coordinator jobs in Quincy, 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.

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 - 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.

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.

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 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.

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.

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

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. 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 The CRA is an important member of the Alira Health Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Job Description 2+ years oncology monitoring is a requirement for this position.KEY RESPONSABILITIES Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. Ensures appropriate and timely investigator site visits. Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. Assists in development of study-specific Monitoring Plans and training presentations as required. Assists in set up/collection of site specific ethics documents and site contract negotiation as required. Provides monthly billing information to finance team as required. For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor. Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. Ensures integrity of CRF data through meticulous and thorough source document review and verification. Performs quality control and verification of documents collected at sites for eTMF/TMF. Conducts investigational product accountability. Reviews site regulatory binder for required documents. Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs. Participates in internal, client/sponsor, scientific, and other meetings as required. Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data. Proactively identifies site issues and develops problem-solving strategies for sites. Conducts audit preparation at study sites as needed. Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. Participates in internal, client/sponsor, scientific, and other meetings as required. Assists in CRA new hire training and onboarding. Performs CRA mentoring. Collaborates with development and maintenance of Clinical Trial Management System (CTMS). Manages and resolves conflicting priorities to deliver on commitments. Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE EU: Graduation in a scientific health field EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members Ability to autonomously manage monitoring activities TECHNICAL COMPETENCES & SOFT SKILLS Quality focused; 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 Able to manage priorities, organize time and solve problems Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Ability to travel Ability to manage stress Professional, trustworthy and disciplined Ability to problem-solve unstructured or ambiguous challenges Strong command of Local language, both written and verbal, in the country where monitoring activities are performed Excellent communication and interpersonal skills with customer service orientation Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture Self-starter who thrives in a collaborative, yet less structured team environment Knowledge of clinical research, ICH GCP and local regulations Knowledge of Regulatory and Ethical requirements EU: Adequate English Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular

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

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

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 General Summary/Overview Statement: The Associate Manager works under direct supervision of a more experienced manager. The Associate Manager provides first-line supervision to research staff members and oversees the day-to-day operations of the staff while maintaining some data management responsibilities and a working knowledge of all aspects of clinical research data management. Principal Duties and Responsibilities: Management responsibilities will include the following: Provide first-line supervision to a minimum of 4-6 FTEs and/or assist with specialized management projects of equivalent responsibility. Facilitate new hire, correction action, and performance evaluation process for research staff Train new staff and assess continuing education needs Assist staff with task prioritization for project assignments by meeting regularly and maintaining meeting documentation Manage staff productivity and quality of work produced by assessing work effort on individual studies Work with sponsors to resolve monitoring issues Management responsibilities may include the following: Work with the Clinical Research Manager or Director to identify changes associated with Standard Operating Procedures and develop processes to ensure compliance Assist with pre-activation activities including pre-site qualification visits, SIVs, and facility tours Assist investigators with the completion of the New Protocol Intake Sheet for regulatory routing Proctor meetings, supply meeting materials and develop group-specific tools Data management responsibilities may consist of the following: Verify patient eligibility via chart abstraction and analysis of case data Collect and interpret data necessary for enrollment; register patients Implement and monitor procedures to ensure protocol compliance Manage data collection via chart abstraction and submit data in timely fashion Monitor and report adverse events as required by institutional/federal regulations Resolve data discrepancies Prepare IRB submission of protocol revisions, safety reports, annual progress reports Assess impact of new risk information on consent documents and revise appropriately Organize and attend on- and off-site Investigator meetings to establish procedures Organize and prepare for monitoring visits and both internal/external audits Skills/Abilities/Competencies Required Demonstrated time management and organization skills Strong written and verbal communication skills Knowledge of current and developing clinical research trends Sound interpersonal skills Ability to work independently and display initiative Demonstrated ability to successfully manage multiple projects Established rapport with investigators and sponsors with the ability to resolve operational matters within a disease group Potential to effectively supervise and train staff Supervisory Responsibilities Orient and train new staff and may supervise a minimum of 4-6 FTEs Working Conditions Duties will be performed in a hybrid setting Qualifications Education Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Research Related Experience 3-5 years required and Supervisory Experience 1-2 years preferred Knowledge, Skills and Abilities * Trains, manages and mentors subordinate staff. * Assigns responsibility to subordinates. * Ability to design, prepare, deliver and evaluate clinical research programs. * Exceptional project management skills. * Effectively arranging resources and managing multiple small to large projects in a cross-functional environment. * Effective multitasking and time management skills. * Strong analytical, quantitative and communications skills. Additional Job Details (if applicable) Remote Type Hybrid Work Location 55 Fruit Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $62,004.80 - $90,750.40/Annual Grade 7 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.

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

The Computational Health Informatics Program (CHIP) is seeking an experienced, highly motivated Senior Clinical Research Coordinator (Enroller) to support a flagship initiative developing and evaluating new methods to bring population-level evidence into everyday clinical practice. This is a rare opportunity to join one of the most influential teams in biomedical informatics and open-source health IT-a group whose work has shaped how data are used across healthcare and who is now building the next generation of data-supported care. In this role, you will work closely with patients, families, and a wide range of clinical teams, supporting enrollment, coordinating data collection, and ensuring that study activities fit the realities of clinical workflow. You will be part of a fast-moving, collaborative environment in which clinicians, data scientists, and research staff work side by side to test tools that will ultimately be used across the country. You will feel the direct impact of your work-not only in each patient interaction, but in advancing a national capability that aims to improve care for children everywhere Key Responsibilities * In conjunction with the Principal Investigator 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 Principal Investigator and/or designees 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 Principal Investigators 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 in implementation and managing ancillary study grants. Minimum Qualifications Education: * Bachelor's degree, Master's preferred. Experience: * Bachelor's degree and 4 years of relevant work experience OR Master's degree and 2 years of relevant work experience. * Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex. * Well-developed communication skills to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions. * Ability to effectively engage with and influence others; build working relationships and can work independently and as a team member, leads others when needed. * Act as a resource and must be knowledgeable and compliant in all hospital, State, and Federal regulatory requirements, including hospital policy and procedures. 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.

**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.

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 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.

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. Sr. CRC role working in The MGH Crohn's and Colitis center in the AMC Medicine Division of Gastroenterology, Hepatology & Endoscopy. Job Summary Summary Working independently and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Additionally, provide input into determining study subject suitability, input into recruitment strategy, methodology design, statistical analyses, protocol design, and manuscript writing. Does this position require Patient Care? No Essential Functions -Independently determines the suitability of study subjects. -Develops and implements recruitment strategies. -Participates in the design of research methodology. -Plans, performs, and designs statistical analyses. -Recommends protocol changes, writes protocols, and contributes to manuscripts. -Independently performs specialized projects. Qualifications Education Bachelor's Degree Related Field of Study required or Graduate Diploma Related Field of Study preferred Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Related post-bachelor's degree research experience 3-5 years required Knowledge, Skills and Abilities - Ability to work more independently and as a team member. - High degree of computer literacy and analytical skills. - Ability to identify both technical and non-technical problems and develop solutions. - Ability to interpret acceptability of data results. - Highly proficient data management skills and working knowledge of data management systems. - Able to display initiative to introduce innovations to research study. - Excellent time management, organizational, interpersonal, written, and verbal communication skills. Additional Job Details (if applicable) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Onsite Work Location 165 Cambridge 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.

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. Job Summary coverletter required to be considered for this position Under the guidance of the Principal Investigator and Senior Project Manager, the Senior Research Clinical Study Coordinator functions independently and proficiently with minimal oversight. They are responsible for the complete coordination of assigned clinical research activities within all phases and complexities of the clinical trial, including investigator-inititiated or other high-profile research. Demonstrates competence in clinical research skills, problem solving, priority setting and assists with the management of less experienced staff. PRINCIPAL DUTIES AND RESPONSIBILITIES: Oversees, prepares, submits and maintains all regulatory submissions (new studies, annual reviews, amendments) in a timely manner. Has a strong understanding of clinical trial endpoints and the ability to sufficiently evaluate and process data Oversee and/or responsible for the Institutional Review Board (IRB) submissions and other regulatory forms and adhering to the timelines of the study start-up process. Develop informed consent documents, source documents, and other documents as applicable. Responsible for educating new staff and research participants on protocol expectations and proper conduct of clinical trials. Interact with potential study participants and study participants to implement protocol with fidelity. Provide participant education, procedural instruction, and follow-up. Serve as a liaison between study participant and research team. Responsible for collecting data and maintaining participant information database for study. May be required to input data, do minimum analysis and run various reports. Support the safety of clinical research participants. Understand and proficiently communicate all components of research documents, such as protocol, informed consent, investigator brochure and research instructions. Responsible for mailing various study information or packets to study participants. Answer any phone calls and inquiries regarding study protocol. Refer participants to principal investigator or co-investigators as clinically indicated. Responsible for training and orienting all new staff. Interact with study monitors, scheduling monitoring visits as indicated, and providing timely responses to study queries. Maintain study inventory and order study supplies when necessary. Ensures the appropriate delegation of study related tasks (i.e.: Delegation of Authority) on all protocols. Communicate with participant's clinical care providers as needed and document research visits within electronic health record system, in compliance with institutional policies. Contribute to research team environment, serving as back-up coordinator to support other studies in department, cross-training/peer-mentoring other team members, and contributing to research meetings. All other duties, as assigned. Qualifications Education Bachelor's Degree Related Field of Study required or Graduate Diploma Related Field of Study preferred Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Related post-bachelor's degree research experience 3-5 years required Knowledge, Skills and Abilities * Ability to work more independently and as a team member. * High degree of computer literacy and analytical skills. * Ability to identify both technical and non-technical problems and develop solutions. * Ability to interpret acceptability of data results. * Highly proficient data management skills and working knowledge of data management systems. * Able to display initiative to introduce innovations to research study. * Excellent time management, organizational, interpersonal, written, and verbal communication skills. Additional Job Details (if applicable) Remote Type Onsite Work Location 221 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.

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.