Clinical research associate jobs in Lowell, MA - 659 jobs

Massachusetts General Hospital and Harvard Medical School are seeking a highly motivated candidate to join the Immunobiology Laboratory. The role focuses on innovative clinical trials for the treatment of type 1 diabetes using the BCG vaccine, with opportunities to gain hands-on experience in regulatory medicine and translational research. Full time, 100% onsite and predominately early morning visits starting at 700AM, M-F. Anticipated working hours are 7AM-4PM. The CRC-Senior will oversee program-wide regulatory and operational needs across multiple supportive care research studies. In addition to contributing to projects employing qualitative methods, survey data, and clinical trial designs, the CRC-Senior will help develop and implement standard operating procedures, onboard and train junior clinical research coordinators (CRCs), and ensure high-quality study execution and compliance. This position is ideal for candidates with prior research experience who are ready to take on supervisory and program development responsibilities. Key Responsibilities Leadership & Training Train, and mentor entry-level CRCs, ensuring adherence to standard operating procedures and best practices. Study Coordination Provide an extra layer of support in managing studies, including participant eligibility reviews, recruitment, informed consent, and coordination of study visits. Assist with data collection (surveys, interviews, chart reviews) and quality control checks, using REDCap (Research Electronic Data Capture) or other programs. Regulatory & Compliance Prepare and maintain Institutional Review Board (IRB) protocol submissions, amendments, continuing reviews, and adverse event reports. Ensure compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies. Assist in coordinating Data Safety Monitoring Board (DSMB) meetings. Update and review Standard Operating Procedures (SOPs). Program Development Assist in developing standard operating procedures and quality assurance systems. Contribute to creation of study templates and guidance for protocol design, database management, and grant submissions. Qualifications Education & Experience Bachelor's degree required (health sciences, psychology, public health, nursing, or related field preferred) Minimum of 5 years of post-baccalaureate research experience in clinical trials or human subjects research, including direct experience with IRB/regulatory documentation. Skills & Competencies Ability to oversee, train and evaluate others effectively. Strong organizational, time management, and problem-solving skills. Excellent interpersonal and written/verbal communication skills. Ability to work independently and collaboratively across multiple investigators and teams. Familiarity with REDCap and other data capture systems preferred.

Site: Mass General Brigham Incorporated 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. General Summary/Overview Statement: The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact. Working Conditions: Remote Job Summary Principal Duties and Responsibilities: The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager: · Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria · Enroll patients as required by the study sponsor and internal enrollment monitor team · Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance · Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. · Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations · Maintain research charts and/or electronic files for all enrolled patients · Ensure adequate source documentation is in place for all data reported · Resolve data queries issued by the sponsor · Obtain protocol clarifications from the study sponsor and communicate information to the research team · Schedule and prepare for monitoring visits with sponsors · Organize and prepare for internal and external audits · Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies The following regulatory duties may be performed under general supervision by the Clinical Research Manager: · Maintain and organize study specific regulatory binders · Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB · Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study · Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required · Submit Data and Safety Monitoring Reports · Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process · Collect, complete, and submit essential regulatory documents to various regulatory entities · Participate in monitoring visits and file all monitoring visit correspondence · Ensure appropriate documentation of delegation and training for all study staff members · Maintain screening and enrollment logs Skills/Abilities/Competencies Required · Careful attention to detail · Good organizational skills · Ability to follow directions · Good communication skills · Computer literacy · Working knowledge of clinical research protocols · Ability to demonstrate respect and professionalism for subjects' rights and individual needs 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 Research Related Experience 1-2 years preferred Knowledge, Skills and Abilities - Attention to detail. - Ability to recognize compliance and data integrity issues and respond appropriately. - Working knowledge of clinical research protocols. - Ability to communicate effectively with patients, vendors, contract research organizations and professional staff. - Effective interpersonal and communication skills. Additional Job Details (if applicable) Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 0100 Mass General Brigham Incorporated 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.

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description · The in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the the Clinical Project Manager(s). · The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager. · The CRA performs work within established protocols under general supervision. · Assists the study team(s) to deliver the clinical study within agreed timelines. · Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors. (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.) Provides oversight of Clinical CRO Investigator background checks. · Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary. · Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP. · Reviews Clinical Monitoring Reports and correspondence related to restudy and Initiation Visits and follows up with Clinical CRO to resolve open action items. · Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager. · Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System. · Assists and/or participates in planning and conduct of Investigator's Meetings as necessary. · Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced. · Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager. · Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present. · Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements. · Assists study team with preparation for audits/inspections Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager. · Liaises with Transparency group to ensure Clintrials.gov is updated. Additional Information Feel free to forward my email to your friends/colleagues who might be available. Thanks, Warm Regards, Kavita Kumari Integrated Resources, Inc. Direct: (732) - 844 8725

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

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, 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

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, 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

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

Site: Mass General Brigham Incorporated 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. General Summary/Overview Statement: The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact. Working Conditions: Remote Job Summary Principal Duties and Responsibilities: The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager: * Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria * Enroll patients as required by the study sponsor and internal enrollment monitor team * Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance * Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. * Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations * Maintain research charts and/or electronic files for all enrolled patients * Ensure adequate source documentation is in place for all data reported * Resolve data queries issued by the sponsor * Obtain protocol clarifications from the study sponsor and communicate information to the research team * Schedule and prepare for monitoring visits with sponsors * Organize and prepare for internal and external audits * Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies The following regulatory duties may be performed under general supervision by the Clinical Research Manager: * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Submit Data and Safety Monitoring Reports * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs Skills/Abilities/Competencies Required * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols * Ability to demonstrate respect and professionalism for subjects' rights and individual needs 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 Research Related Experience 1-2 years preferred Knowledge, Skills and Abilities * Attention to detail. * Ability to recognize compliance and data integrity issues and respond appropriately. * Working knowledge of clinical research protocols. * Ability to communicate effectively with patients, vendors, contract research organizations and professional staff. * Effective interpersonal and communication skills. Additional Job Details (if applicable) Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 0100 Mass General Brigham Incorporated 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.

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at ************************* Job Description • Requires Bachelors degree from accredited US College or University • Position can NOT be remote, no relocation • This is a 6 month contract - may be extended but not guaranteed • Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor) • Experience with finances, accounting or invoicing a plus Qualifications • Requires Bachelors degree from accredited US College or University Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor) Additional Information All your information will be kept confidential according to EEO guidelines.

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.

The role of Clinical Trial Coordinator (CTC) is a newly established role at Gubra to support our expanding clinical drug development activities. These development activities are currently focused on early phase clinical trials with the majority of operational execution supported by contract research organizations (CROs) and external partners. In this role you will work closely together with a Clinical Trial Manager to maintain high quality trial documentation and to coordinate the logistical and administrative activities required during trial start-up, execution and closing of clinical trials. The role takes responsibility for GCP-related activities. Your key responsibilities will include: * Documentation & Regulatory Compliance * Coordination & Communication * Trial Operations Support * Data & Quality Management * Maintain and organize the Trial Master File (TMF) to meet regulatory and procedural requirements. * Ensure compliance with ICH-GCP guidelines, SOPs, and local regulations throughout the trial lifecycle. * Act as a central point of contact between clinical operations, vendors, CROs and investigational sites regarding administrative and logistical deliverables. * Coordinate logistics for meetings, site visits, reviews etc. * May participate in operational feasibility assessment and selection of vendors. * Assist in preparing and reviewing core trial documents (protocols, informed consent forms, case report forms, Operations and Pharmacy Manuals, etc.). * Track progress and maintain oversight of study activities against timelines and report updates to the clinical project team. * Support the trial team in the identification, documentation, resolution and escalation of issues. * Manage inventory and distribution of clinical trial supplies, including investigational products. * Assist with site initiation, close-out, archiving of study documents, and preparation of final study reports * Assist in tracking invoices, site payments and vendor contracts against the overall trial budget. * Participate in data cleaning activities and coordinate query resolution with site monitors and investigators. * Support quality control and quality assurance activities, including reviews of trial data and documentation for accuracy and completeness. * Contribute to the development of SOPs and best practices for future trials. * Support inspection readiness and internal/external audits by preparing checklists and ensuring documentation integrity. Your background: You have a bachelor degree in life sciences, health sciences, clinical research or related disciplines with a minimum of 2-3 years of clinical research experience, clinical operations or similar administrative role. In addition: * You have a good understanding of Good Clinical Practice (GCP), the regulatory requirements and documentation processes related to clinical trial lifecycle . * Experience with oversight of external CROs/vendors is required. * Proficiency with Clinical Trial Systems (eTMF, EDC etc.) is required. As a person you contribute with: * Strong organizational skills as well as attention to detail, ensuring efficient and accurate work processes. * Good communicator skills, towards internal and external stakeholders. * Possess a biotech-mindset and thrive in an environment of growth and changes. Contact and Application Please apply using the "Apply" button. The deadline is January 18, 2026. If you have questions regarding salary or practical matters, you are welcome to contact HR Partner, Simone Sparholt at ************. Questions regarding role-specific details will be addressed during the interview. We are looking forward to receiving your application. About Gubra Gubra is an ambitious contract research organisation (CRO) and biotech company striving for excellence at all levels. We insist on doing things efficiently - and often differently - to reach the results we aim for. Our vision is to become leaders in the fight for a more sustainable and healthier world. We do that by facilitating the discovery of new medicine, and by acting and inspiring others to fight the ongoing climate and biodiversity crises. Gubra's activities are focused on the early stages of drug development and are organised in two highly synergistic business areas: CRO Services and Discovery & Partnerships (D&P). We generate our revenue by performing research for life science companies as well as by partnering projects from our discovery and development pipeline. Our therapeutic focus is within metabolic and fibrotic diseases, and we specialize in in vivo pharmacology, ex vivo assays, drug profiling, histology, stereology and whole brain and organ imaging. In addition, we offer a full palette of advanced transcriptomics. Our ML/AI-driven peptide drug discovery platform strea MLine enables us to rapidly develop a peptide hit into a non-clinical candidate ready for development. Through a constant focus on high quality, scientific excellence, speed, and solid teamwork we have established ourselves as a highly professional and competent partner in the market. People are our greatest asset, and our team consists of +290 employees all located in Hørsholm, Denmark. The mix of people from different cultures and educational backgrounds combined with our entrepreneurial mindset have greatly impacted our working environment, which is characterized by entrepreneurial drive, scientific curiosity, and teamwork - we join forces!

Clinical Research Assistant Needed The role involves monitoring participants using various technology products, collecting data, and ensuring the proper functioning of devices and data collection throughout the study sessions. Great opportunity to gain experience in clinical research! Schedule: * Monday - Friday * 7:30am-3:00pm or 2:00pm-9:00pm *can be flexible* Responsibilities * Consent participants according to protocol and take necessary vitals and measurements (height, weight, EKG) throughout the session. * Ensure participants are properly set up with devices and any monitoring equipment. * Operate several pieces of instrumentation and observe participants using devices during various activities as per protocol. * Ensure data monitoring is functioning properly throughout the session and ensure proper data collection. * Guide participants through the study and support data collection directly. Required Skills * Experience in research and data entry. * Bachelor's Degree in science, exercise science, kinesiology, or biology. * Technical proficiency to operate test devices and perform data entry. * Ability to direct participants through the study, with examples of patient care or people interaction. "Nice to have" Qualifications * Experience in human subject research and data analysis. * Familiarity with gym equipment and clinical research. Pay and Benefits The pay range for this position is $25.00 - $25.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Natick,MA. Application Deadline This position is anticipated to close on Apr 30, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

The Clinical Research Coordinator (CRC) will work within the Center of Cancer Therapeutic Innovation (CCTI) department supporting the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. Will support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements. May be responsible for pertinent IRB protocol submissions. This individual may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the clinical trials management system, ONCORE. Some travel may be required. 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. + Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. + Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries. + May prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable. + Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations. + Collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments, as needed per the requirements of the clinical trial. + Responsible for organizing and preparing for both internal and external auditing and study monitoring visits. + Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities. + Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved. + Interact with study participants as directed/required by the protocol and/or study team. + May be responsible for tissue sample collection per trial requirements. + Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information. + Responsible for data entry of time and effort spent on study-specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed. + Responsible for data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed. **KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:** + Excellent organization and communications skills required. + Strong interpersonal skills - ability to effectively interact with all levels of staff and externals contacts. + Must be detail oriented and have the ability to follow-through. + Ability to effectively manage time and prioritize workload. + Must practice discretion and adhere to hospital confidentiality guidelines at all times. + Must have computer skills including the use of Microsoft Office. **MINIMUM JOB QUALIFICATIONS:** + Bachelor's Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience required. 0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. **SUPERVISORY RESPONSIBILITIES: None** **PATIENT CONTACT:** **All positions:** May have contact with Adult and Pediatric patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. **EEO Poster** . Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA). $48,100.00 - $54,400.00

The Division of Genetics and Genomics at Boston Children's Hospital is seeking an experienced Clinical Research Coordinator to assist with clinical research projects that focus on Angelman syndrome in both children and adults. The primary role will be to oversee the operations of a large investigator-initiated, multi-center natural history study of Angelman Syndrome. Key Responsibilities * Assisting Principal Investigators (PI) with designing and implementing clinical research protocols, including: coordinating the preparation of protocol applications for Institutional Review Board (IRB) submissions, managing stakeholder contracts, ensuring regulatory compliance across study sites, and overseeing the day-to-day activities of the study. * Delivering regular updates and progress reports to PIs and sponsors, including organizing and leading steering committee sessions focused on continuous improvement. * Conducting virtual and in-person study site visits (pre-study, initiation, monitoring, and close-out) and ensuring sites complete deliverables within given timelines. * Maintaining multiple study databases by coordinating data entry and updates, optimizing data retrieval processes, and enhancing user interface and system performance. * Routinely review and verify study data for accuracy and completeness. * Creating and implementing subject recruitment and enrollment strategies for study sites. * Developing case report forms (CRFs), protocols, training manuals, and other study related documents. * Preparing conference presentations and manuscripts by cleaning and preparing datasets for analyses. Minimum Qualifications Education: * Bachelor's Degree 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 * Strong quantitative and analytical skills, including use of statistical software and programming languages such as R or Python * Interested in working with children and adults with severe physical and intellectual disabilities, and their families * Excellent interpersonal as well as oral and written communication skills * Willingness to work flexible hours, as and when 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.

Job Description 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 to 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 DifferenceThe Travel Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. This role will perform a variety of clinical and administrative tasks in support of clinical trials and assist in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies. Much of the work for this role will be done onsite at a clinical event or site location. How You'll Make An Impact Perform independent venipuncture; manage difficult draws and re-attempts per protocol. Collect, label, process, package, and ship biospecimens; maintain chain of custody and temperature controls. Set up/tear down event sites; prepare kits/supplies; uphold aseptic technique and biohazard safety. Communicate clearly with participants and on-site teams; escalate issues promptly. Ability to understand and follow institutional SOPs. Participate in recruitment and pre-screening events (may be multiple locations). Assist with preparation of outreach materials. Request medical records of potential and current research participants. Schedule visits with participants, contact with reminders. Obtain informed consent per Care Access Research SOP, under the direction of the Clinical Research Coordinator (CRC). Complete visit procedures as required by protocol, under the direction of the CRC. Record data legibly and enter in real time on paper or e-source documents. Request and issue study participant payments. Update all applicable internal trackers and online recruitment systems. Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. Assist with maintaining all site logs. Assist with inventory and ordering equipment and supplies. 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/participants, sponsor representatives, Investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Ability and willingness to work independently with minimal supervision. Ability to learn to work in a fast-paced environment. Excellent communication skills and a high degree of professionalism with all types of people Excellent organizational skills with strong attention to detail A working knowledge of medical and research terminology A working knowledge of federal regulations, Good Clinical Practices (GCP) Critical thinker and problem solver Friendly, outgoing personality with the ability to maintain a positive attitude under pressure. Contribute to team and site goals. Proficiency in Microsoft Office Suite High level of self-motivation and energy An optimistic, "can do" attitude. Certifications/Licenses, Education, and Experience: 1+ year recent hands-on phlebotomy experience in a clinical setting. ≥200 total venipunctures; ≥25-50 capillary sticks; ≥30-50 sticks in the last 2-3 months. Some Clinical Research experience preferred. Demonstrated competency in specimen processing. Working knowledge of ICH-GCP, basic research terminology, and HIPAA/PHI handling. Comfortable using mobile apps/eSource and standard office tools. Current national phlebotomy certification (one of): ASCP Phlebotomy Technician (PBT) AMT Registered Phlebotomy Technician (RPT) NHA Certified Phlebotomy Technician (CPT) NCCT National Certified Phlebotomy Technician (NCPT) CA/WA/LA/NV specific licensure/certification if role is based there How We Work Together Location: Candidates must be willing to travel in support of community events within your metropolitan area and occasional national travel. Travel: Duties may require travel in the following models: Tuesday through Saturday Work Weeks Temporary Event Support (3-7-day deployment durations) Frequency and length of travel may depend on the length and location of study, site, and event. Deployments normalize to a 32 to 42-hour work week on average. The expected salary range for this role is $24.00 - $38.00 USD per hour 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: ********************************