Clinical research associate jobs in Warwick, RI

**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.

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.

. You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio. KEY RESPONSIBILITIES Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. Responsible for scientific oversight, data integrity and quality of the clinical trial(s). Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy. Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate. Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders. In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s). Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure. MINIMUM QUALIFICATIONS PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance Experience working on large data sets Proficiency with Microsoft Office and relevant scientific software Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery Experience leveraging a variety of communication tools and techniques to communicate results Experience solving problems collaboratively and handling conflict constructively Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations Experience working proactively and independently, organizing tasks, time and priorities of self and others Experience building partnerships across the company to achieve the needs of the program PREFERRED QUALIFICATIONS Experience in Hematology Oncology COMPETENCIES FOR SUCCESS Demonstrates passion for helping patients with cancer and for the science of oncology Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities Promotes team health and exemplifies Pfizer's leadership behaviors and actionable attitudes Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies Demonstrates foresight and judgment to make complex decisions Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development Has a global perspective and mindset. Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. both as a leader and a key contributor Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week. The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical

6-12 Month Project - Hybrid in Boston / 4x per week as needed with patients $30/HR W2 Clinical Research Coordinator (CRC) will perform research activities using approved techniques. The CRC procures, processes and ships research specimens and conducts patient recruitment, administers questionnaires, abstracts medical records, maintains patient databases and more. Hybrid schedule however will be on site for a majority of the work with research participants Responsibilities Evaluating and tracking the eligibility of all patients seen in the clinic. Obtaining informed consent and registering patients to cohort studies and other protocols. Reviewing and abstracting the medical records for patient Entering information into the appropriate EMR and eCRF systems Maintaining on-going communications with research managers and PIs for data collection needs Qualifications Bachelor's Degree require 2+ years of experience in a research setting performing similar project responsibilities

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

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

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

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.

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

Job Description Are you passionate about clinical research and ready to make an impact on patients' lives? We're looking for a Clinical Research Associate (CRA) to join a fast-growing biotech company (confidential) that's advancing innovative therapies in neuroscience. What You'll Do: Conduct site initiation, monitoring, and close-out visits to ensure trials meet the highest quality standards. Review and verify study data for accuracy and completeness. Collaborate with site staff and cross-functional teams to solve challenges and keep trials on track. Identify and escalate any protocol deviations, safety concerns, or data issues. Requirements What We're Looking For: Bachelor's in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus). 3+ years of CRA or site monitoring experience. Strong knowledge of ICH-GCP and FDA regulations. Excellent communication, organization, and problem-solving skills. Willingness to travel as needed (up to 50-75%). Extra Credit: Experience with CNS or rare-disease trials. Benefits Amazing benefits package starting day one!

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, 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

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

Dana-Farber Cancer Institute (DFCI) is seeking a highly motivated Pre-Clinical Scientist to support the research activities at the Experimental Therapeutics (ETx) Core and the Lurie Family Imaging Center (LFIC). The ETx Core and LFIC are co-located in a state-of-the-art 14,000 square-foot preclinical facility, fully equipped with housing and procedure rooms, as well as a suite of in vivo imaging scanners. The Pre-Clinical Scientist will integrate with a highly skilled team of Scientists and Research Associates, and report directly to the Director. The in vivo studies conducted at the facility are focused on cancer research, with an emphasis on in vivo pharmacology, the assessment of novel cancer therapeutics, and multimodality imaging of cancer, and provide key information for the improvement of cancer patient treatment and care. The position is at 27 Dry Dock Ave, South Boston ****************************** Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. Responsibilities The successful candidate will work collaboratively and in concert with a staff of dedicated scientists, animal/imaging technologists/associates, administrative personnel, and clinical counterparts to design and execute oncology related mouse studies using various imaging modalities (BLI/MRI/SPECT/PET/CT, etc) as well as the entire spectrum of conventional (e.g., caliper measurements, clinical scoring) endpoints to evaluate pre-clinical novel cancer therapies. The Pre-Clinical Scientist will work closely with the Director to execute the vision and strategic direction of translational cancer research. The Pre-Clinical Scientist will partner with clinical affiliates to facilitate bidirectional translational cancer science. The Pre-Clinical Scientist will work closely with other Centers and Departments at Dana-Farber that are engaged in research on small animal modeling in cancer and in experimental therapeutics. The Scientist will be expected to develop research projects for presentation at national meetings and publication in peer-reviewed journals. The Pre-Clinical Scientist will build collaborations with principal investigators, other departments, and industrial partners to design experimental therapeutics studies, and will be responsible for the execution, analysis and generation of reports for studies. Skills and Abilities Required * Hands-on experience using various cell line and PDX mouse/rat models and orthotopic models to execute in vivo workflows is highly desired. * Familiar with IVIS, PET/CT, MRI and other imaging approaches. * Demonstrated ability to deploy novel in vivo models to enable drug discovery and translational research. * Excellent interpersonal and communication skills with the ability to interact effectively with internal and external collaborators. * Demonstrated expertise in various in vitro methodologies such as immune profiling by flow cytometry, ELISA and Western blot analysis. * Ability to establish independent research and secure external funding * Full-time, M-F; hours may vary with project needs Dana-Farber Cancer Institute supports a robust Scientist career track with multiple opportunities for advancement, leadership, and recognition. The successful candidate will be appointed to a level within the Scientist career track commensurate with his or her accomplishments and abilities. Promotion on this track will be based on achievement of goals. Qualifications * PhD cancer biology, biology or relevant biological sciences * Minimum of 5 years' experience in pre-clinical pharmacology pre- or post-PhD * Established track record of research publications, preferably in cancer research * Builds productive internal/external working relationships. * Having wide-ranging experience, uses technical concepts and Institute objectives to resolve complex issues in creative and effective ways. * Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. * Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. * Networks with key contacts outside our own area of expertise. Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA) $80,000 - $82,900 At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. EEOC Poster

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. Key Responsibilities * Responsible for overall quality, maintenance, and completeness of Trial Master Files. * Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. * Develop project specific TMF plan and structure and update the plan as needed. * Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. * Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. * Act as a liaison between the Site IRBs and study team to resolve queries and concerns. * Provide study team reports or updates regarding status of TMF on a regular basis. * Participate in audits and provide documents as requested. * Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. * Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. * Champion best practices for building and maintaining TMF health. Professional Experience / Qualifications * BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings * Knowledge of and direct experience with Trial Master Files. * Prior eTMF (e.g. Veeva) administration required. * Strong Microsoft Office skills required. * Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). * Fundamental knowledge of the conduct of clinical trials is preferred. * Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. Key Responsibilities Responsible for overall quality, maintenance, and completeness of Trial Master Files. Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. Develop project specific TMF plan and structure and update the plan as needed. Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. Act as a liaison between the Site IRBs and study team to resolve queries and concerns. Provide study team reports or updates regarding status of TMF on a regular basis. Participate in audits and provide documents as requested. Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. Champion best practices for building and maintaining TMF health. Professional Experience / Qualifications BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings Knowledge of and direct experience with Trial Master Files. Prior eTMF (e.g. Veeva) administration required. Strong Microsoft Office skills required. Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). Fundamental knowledge of the conduct of clinical trials is preferred. Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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 The Clinical Research Assistant II (CRA II), to be based in the Osher Center's Mind-Body-Movement Laboratory, will work directly with the Principal Investigator (PI) and Director of the Osher Center for Integrative Health to advance the Center by performing a variety of tasks. The Center is based in the Division of Preventive Medicine at Brigham and Women's Hospital. The CRA II will play an integral role in two ongoing projects in integrative health research: Qualifications 1. Acupoint Sensitization in Inflammatory Bowel Disease (IBD):This is a clinical and translational (C/T) study aimed at addressing knowledge gaps surrounding the biology and scientific basis of acupoints. Based on prior preclinical studies demonstrating cutaneous sensitization or neurogenic inflammation at specific acupoint locations in animal models of colitis, we aim to translate these findings in humans subjects by investigating cutaneous (acupoint) sensitization in IBD.Specific to this project, the CRA II will assist with: Conducting laser speckle contrast imaging (LSCI) and infrared thermography to measure cutaneous blood perfusion and temperature, respectively Performing pressure pain threshold (PPT) assessments Coordinating the collection and storage of biospecimens, including stool and blood samples 2. Effect of Photobiomodulation (PBM) on Stress Physiology:This is a sham-controlled, within-subjects clinical study aimed at evaluating whether or how PBM, a light-based therapy, affects heart rate variability (HRV) under acute stress.Specific to this project, the CRA II will assist with: Setting up and conducting clinical evaluations, including the stress test, and the delivery of PBM or sham intervention Collecting HRV and other physiological data (e.g., electrodermal activity, blood pressure) Additional Job Details (if applicable) GENERAL DUTIES AND RESPONSIBILITIES: Assist with recruitment and enrollment of study participants. Administer phone screens and assess potential participants' eligibility for inclusion in the study via screening forms and checklists. Collect in-person informed consent and oversee enrollment process that follows. Interact with participants prior to enrollment and maintain communication/compliance throughout study life-cycle. Actively participate in data collection, including administering questionnaires and collecting biological samples and physiological data. Develop and pilot-test data collection forms and procedures (hardcopy and/or electronic databases, etc.) Directly respond to inquiries regarding study protocol and policy. Serve as liaison or point-person for the study. Communicate with the PI concerning appropriate issues during interaction with participants. Plan agendas and provide logistical support for meetings with study teams. Collaborate on manuscripts for peer-reviewed journals, including co-authorship of papers. Participate in decisions made for the study and formulation of study-specific policies and procedures. Identify modifications needed and work to implement solutions. Performs all other duties, as assigned. SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: Ability to work well in a team, as well as independently. Ability to organize and prioritize multiple tasks, and set deadlines. Excellent interpersonal, oral, and written communication skills. Careful attention to detail. Computer literacy and word processing skills. Ability to demonstrate professionalism and respect for subjects rights and individual needs. Ability to manage and maintain accurate records across several ongoing projects. Comfort with technology and ability to learn new research tools and devices; all necessary training will be provided. HOSPITAL WIDE RESPONSIBILITIES: Works within legal, regulatory, accreditation and ethical practice standards relevant to the position and as established by BWH/Mass General Brigham (MGB); follows safe practices required for the position; complies with appropriate BWH and MGB policies and procedures; fulfills any training required by BWH and/or MGB, as appropriate; brings potential matters of non-compliance to the attention of the supervisor or other appropriate hospital staff. Remote Type Hybrid Work Location 900 Commonwealth Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $23.80 - $34.81/Hourly 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.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Patient Coordination * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Maintain effective relationships with study participants and other care Access Research personnel. * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Prescreen study candidates * Obtain informed consent per Care Access Research SOP . * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines * Assist regulatory personnel with completion and filing of regulatory documents. * Assist in the creation and review of source documents. * Patient Recruitment * Assist with planning and creation of appropriate recruitment materials. * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct * Communicate clearly verbally and in writing * Attend Investigator meetings as required * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) The Expertise Required * Ability to understand and follow institutional SOPs. * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 3 years prior Clinical Research Coordinator experience required * Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator * Recent phlebotomy experience required * Licenses: * California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health * Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners * Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health * Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together * Location: This is an on-site position with regional commute requirements, located in Warwick, Rhode Island * Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. * Type of travel required: Regional (within 100 miles) * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. * Walking - 20% * Standing - 20% * Sitting - 20% * Lifting - 20% * Up to 25lbs * Over 25lbs Overhead * Driving - 20% The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************