Clinical research coordinator jobs in Worcester, MA - 360 jobs

A leading biopharmaceutical company is seeking a Head of Research Quality to provide strategic oversight and leadership within their Research Quality organization. This role is crucial in defining, executing, and overseeing compliance and integrity in non-clinical research activities. The ideal candidate will have extensive experience in the biopharma sector, excellent leadership and communication skills, and a strong understanding of global regulations. This position is based in Boston, MA, offering a competitive salary range of $208,200 - $327,140, along with comprehensive benefits including medical insurance and a 401(k) plan. #J-18808-Ljbffr

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. 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. 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 Job Summary Summary Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. Does this position require Patient Care? No Essential Functions -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. -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 maintain a record of all correspondence related to these visits. 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) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Hybrid Work Location 101 Merrimac Street Pay Range $20.16 - $29.01/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: 1200 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.

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Verve, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director - Clinical Research Scientist (CRS) to lead the clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease. In this key role, the CRS in partnership with the Clinical Research Physician provides scientific oversight and strategic leadership throughout the trial lifecycle, ensuring scientific integrity and regulatory compliance, and patient safety. The CRS collaborates with cross-functional teams in the implementation of clinical trials, the review process for protocols and other clinical documents, publications and data dissemination and will contribute to regulatory submissions and help implement biomarker strategies. This high-visibility position offers the opportunity to drive clinical development and engage with key external stakeholders. The ideal candidate will excel in a fast-paced, dynamic environment and possess strong communication skills and attention to detail. Responsibilities: The primary responsibilities of the Verve Associate Director - CRS are related to early-phase gene editing compounds targeting cardiovascular disease. The CRS is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning Contribute to the development of the overall strategy and early phase clinical plan for development of clinical compounds, focusing on studies required for strategic decisions. Collaborate with pharmacokineticists and statisticians by providing clinical support to the development of models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens. Clinical Research/Trial Execution and Support Design and oversee implementation of Phase lb and Ila/IIb clinical studies. Design and write clinical trial protocols. Participate in investigator identification and selection, in conjunction with clinical team. Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials. Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects. Collaborate with clinical and research teams to implement the clinical biomarker strategy for early phase clinical studies Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards) Partners with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions Leads internal meetings to review topics and develop mitigation plans Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Serve as resource to clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Scientific Data Dissemination/Exchange Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Participate in data analysis, development of scientific data dissemination and preparation of final reports. Contribute to the development of presentations, abstracts, and publications emerging from clinical and translational studies Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Regulatory Support Activities Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings, and communications and resolution of regulatory issues, including regulatory response. Business/ customer support Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis. Participate in patent development. Scientific & Technical Expertise and Continued Development Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule. Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic area Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects. Attend scientific symposia. Other activities include internal and external training activities, peer-review of clinical protocols and reports, and ad hoc scientific consultation within Lilly. The CRS works with late stage development colleagues to plan for meeting patient needs through clinical studies, and outcomes and pharmacoeconomic research. Basic Requirements: Bachlores Degree In Health/Medical/Scientific field with 7+ years of pharmaceutical experience that is directly related to at least one of the following: Drug/Clinical Development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Minimum of two years' experience in clinical development Additional Skills/Preferences: 3 + years of clinical experience with Advanced degree Health/Medical/Scientific degree (For example in Pharmacology, Physiology, Microbiology) or related Graduate degree such as DVM, PharmD, PhD, MSN With Advanced Clinical Specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of the following: Minimum 2 of which is in clinical development Has strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices. Demonstrated strong problem-solving and prioritization skills with the ability to resolve trial-related issues and ensure smooth execution. Proven ability to interpret clinical trial data, including safety assessments and efficacy endpoints, and apply it to inform decision-making. Demonstrated leadership skills with the ability to collaborate effectively with cross-functional teams and external stakeholders. Demonstrated excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings. Ability to develop relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs). Familiarity with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus. Ability to travel to clinical sites, conferences, and regulatory meetings as needed. Fluent in English, verbal and written communication Additional Information: Travel 10-15% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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

Clinical Research Associate - Boston ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. **What you will be doing** + Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. + Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. + Collaborating with investigators and site staff to facilitate smooth study conduct. + Performing data review and resolution of queries to maintain high-quality clinical data. + Contributing to the preparation and review of study documentation, including protocols and clinical study reports **Your profile** + Bachelor's degree in a scientific or healthcare-related field highly preferred. + Minimum of 2 years of experience as a Clinical Research Associate. + In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. + Strong organizational and communication skills, with attention to detail. + Ability to work independently and collaboratively in a fast-paced environment. + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

Clinical Research Associate - Boston 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Summary: Working independently and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Additionally, provide input into determining study subject suitability, input into recruitment strategy, methodology design, statistical analyses, protocol design, and manuscript writing. Essential Functions:-Independently determines the suitability of study subjects. * Develops and implements recruitment strategies. * Participates in the design of research methodology. * Plans, performs, and designs statistical analyses. * Recommends protocol changes, writes protocols, and contributes to manuscripts. Qualifications Education Bachelor's Degree Related Field of Study required or Graduate Diploma Related Field of Study preferred Experience Related post-bachelor's degree research experience 3-5 years required Knowledge, Skills and Abilities * Ability to work more independently and as a team member. * High degree of computer literacy and analytical skills. * Ability to identify both technical and non-technical problems and develop solutions. * Ability to interpret acceptability of data results. * Highly proficient data management skills and working knowledge of data management systems. * Able to display initiative to introduce innovations to research study. * Excellent time management, organizational, interpersonal, written, and verbal communication skills. Additional Job Details (if applicable) Remote Type Onsite Work Location 185 Cambridge Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $50,502.40 - $82,014.40/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Clinical Research Associate needs 2-5 years of clinical research experience in industry settings with a bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field Clinical Research Associate requires; oncology experience strongly preferred EDC systems Knowledge of clinical trial methodology as well as the drug research and development process Knowledge of GCP/ICH Guidelines for clinical studies ORACLE CLINICAL TRIALS CLINICAL MONITORING Clinical Research Associate duties are: Participation in the evaluation of clinical trial site locations. Serving as the sponsor liaison to clinical sites during the activation process, as the study progresses, and during study close-out. Traveling to sites as necessary to conduct site qualification, initiation, and close-out ( Collecting and managing regulatory documentation, to ensure compliance with GCP, ICH, regulatory authority, and ethics board requirements. Working with clinical site staff and investigators to obtain study data, ensure protocol compliance, and guarantee patient safety. Ensuring accurate and timely reporting of patient safety issues according to all relevant local and federal requirements. Participating in regional and global conference calls and meetings to review progress of ongoing clinical trials. Reviewing incoming clinical data, and preparing reports and presentations on the status of clinical studies. Helping to draft study manuals and protocol amendments as needed. Organizing and distributing study supplies and study-related documentation required for conduct of clinical trials. Coordinating the movement of laboratory samples between clinical sites and central laboratories, and tracking the status of samples and resulting laboratory data. Additional Information $31/HR 6 months

The Rosamund Stone Zander and Hansjoerg Wyss Translational Neuroscience Center (TNC) is seeking a dynamic and innovative Senior Clinical Research Coordinator to join our team. The TNC strives to improve the lives of all children with neurodevelopmental disorders by fostering timely and efficient translational research. The Sr. Clinical Research Coordinator will collaborate with Principal Investigators and study stakeholders to manage the daily operations of research studies and will develop and oversee the implementation of best practice guidelines for conducting various research protocols. The Sr. Clinical Research Coordinator will contribute to the development of budgets and monitor study finances, oversee maintenance of research equipment, and ensure compliance with hospital and governmental regulations. The Sr. Clinical Research Coordinator will identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and act as a leader in overseeing their resolution. The Sr. Clinical Research Coordinator will manage and train research staff and conduct the Performance Management process. Key Responsibilities: * In conjunction with the Principal Investigator and/or designees designs, develops, and implement clinical research projects such as enrollment strategies, study materials, and study documents. * Responsible for daily operations of the study. Develops and implements processes and procedures to meet study goals and protocol requirements. Participate in training and prepare study related training materials. Plans and prioritizes the work of administrative and support personnel on all clinical study activities. * Consents and enrolls patients for research studies by providing detailed information on the Clinical Study to patients and families. Communicates all policies and procedures and responds to all inquiries. Evaluate the suitability of prospective study candidates and make selections based on clinical knowledge of each study. Provide input for updates of SOPs and drafting of new quality documentation. * Assist with developing and implementing best practice guidelines for conducting various clinical research protocols. Presents and prepares training materials as part of the sponsored educational efforts. * Provides analytical, data management, and methodological support to Principal Investigator and/or designees in the development of clinical research protocols and data management tools. Manages data for single and/or multi-institutional investigations. * Develops study-specific data management and quality assurance procedures and monitors their implementation at site visits and/or periodic review of study data management reports. Education: * A BA/BS degree in health, psychology or a related field is required, Master's Degree is preferred. Experience: * Bachelor's Degree with 4 years of relevant work experience; OR Master's Degree and 2 years of relevant work experience. * Knowledge of clinical research processes and best practices. * Exceptional organizational skills and multi-tasking abilities, with good attention to detail. * The ability to take initiative and work with minimal direct supervision. * Ability to work collaboratively with multi-disciplinary project teams. * Ability to communicate effectively both orally and in writing. 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.

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary The MGH CORE Program is seeking a full-time Senior Clinical Research Coordinator (CRC-Senior) to join our multidisciplinary team. This position offers the opportunity to take on a leadership role in advancing innovative supportive care research in oncology and palliative care. The MGH CORE Program brings together oncologists, palliative care specialists, psychiatrists, psychologists, nurses, and other allied clinician researchers dedicated to improving the quality of care and outcomes for patients and families facing cancer and serious illness. Senior Clinical Research Coordinator (CRC) The CRC-Senior will oversee program-wide regulatory and operational needs across multiple supportive care research studies. In addition to contributing to projects employing qualitative methods, survey data, and clinical trial designs, the CRC-Senior will help develop and implement standard operating procedures, onboard and train junior clinical research coordinators (CRCs), and ensure high-quality study execution and compliance. This position is ideal for candidates with prior research experience who are ready to take on supervisory and program development responsibilities. Qualifications Key ResponsibilitiesLeadership & Training Train, and mentor entry-level CRCs, ensuring adherence to standard operating procedures and best practices. Assist CORE faculty investigators with allocating workload and providing ongoing feedback. Study Coordination Provide an extra layer of support in managing CORE studies, including participant eligibility reviews, recruitment, informed consent, and coordination of study visits. Assist with data collection (surveys, interviews, chart reviews) and quality control checks, using REDCap (Research Electronic Data Capture) or other programs. Regulatory & Compliance Prepare and maintain Institutional Review Board (IRB) protocol submissions, amendments, continuing reviews, and adverse event reports. Ensure compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies. Program Development Assist in developing standard operating procedures and quality assurance systems. Contribute to creation of study templates and guidance for protocol design, database management, and grant submissions. Qualifications Education & Experience Bachelor's degree required (health sciences, psychology, public health, nursing, or related field preferred) Minimum of 2-5 years of post-baccalaureate research experience in clinical trials or human subjects research, including direct experience with IRB/regulatory documentation. Skills & Competencies Ability to oversee, train and evaluate others effectively. Strong organizational, time management, and problem-solving skills. Excellent interpersonal and written/verbal communication skills. Ability to work independently and collaboratively across multiple investigators and teams. Familiarity with REDCap and other data capture systems preferred. Application Instructions Please submit your resume and a cover letter (maximum 300 words) describing your background, interest in supportive care research, and what makes you a strong candidate for this leadership role. We value team members from diverse backgrounds and encourage applicants to share in their cover letter how their unique experiences, perspectives, or interests would contribute to our program's mission. Additional Job Details (if applicable) Remote Type Onsite Work Location 125 Nashua Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 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.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Verve, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director - Clinical Research Scientist (CRS) to lead the clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease. In this key role, the CRS in partnership with the Clinical Research Physician provides scientific oversight and strategic leadership throughout the trial lifecycle, ensuring scientific integrity and regulatory compliance, and patient safety. The CRS collaborates with cross-functional teams in the implementation of clinical trials, the review process for protocols and other clinical documents, publications and data dissemination and will contribute to regulatory submissions and help implement biomarker strategies. This high-visibility position offers the opportunity to drive clinical development and engage with key external stakeholders. The ideal candidate will excel in a fast-paced, dynamic environment and possess strong communication skills and attention to detail. Responsibilities: The primary responsibilities of the Verve Associate Director - CRS are related to early-phase gene editing compounds targeting cardiovascular disease. The CRS is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning Contribute to the development of the overall strategy and early phase clinical plan for development of clinical compounds, focusing on studies required for strategic decisions. Collaborate with pharmacokineticists and statisticians by providing clinical support to the development of models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens. Clinical Research/Trial Execution and Support Design and oversee implementation of Phase lb and Ila/IIb clinical studies. Design and write clinical trial protocols. Participate in investigator identification and selection, in conjunction with clinical team. Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials. Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects. Collaborate with clinical and research teams to implement the clinical biomarker strategy for early phase clinical studies Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards) Partners with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions Leads internal meetings to review topics and develop mitigation plans Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Serve as resource to clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Scientific Data Dissemination/Exchange Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Participate in data analysis, development of scientific data dissemination and preparation of final reports. Contribute to the development of presentations, abstracts, and publications emerging from clinical and translational studies Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Regulatory Support Activities Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings, and communications and resolution of regulatory issues, including regulatory response. Business/ customer support Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis. Participate in patent development. Scientific & Technical Expertise and Continued Development Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule. Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic area Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects. Attend scientific symposia. Other activities include internal and external training activities, peer-review of clinical protocols and reports, and ad hoc scientific consultation within Lilly. The CRS works with late stage development colleagues to plan for meeting patient needs through clinical studies, and outcomes and pharmacoeconomic research. Basic Requirements: Bachlores Degree In Health/Medical/Scientific field with 7+ years of pharmaceutical experience that is directly related to at least one of the following: Drug/Clinical Development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Minimum of two years' experience in clinical development Additional Skills/Preferences: 3 + years of clinical experience with Advanced degree Health/Medical/Scientific degree (For example in Pharmacology, Physiology, Microbiology) or related Graduate degree such as DVM, PharmD, PhD, MSN With Advanced Clinical Specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of the following: Minimum 2 of which is in clinical development Has strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices. Demonstrated strong problem-solving and prioritization skills with the ability to resolve trial-related issues and ensure smooth execution. Proven ability to interpret clinical trial data, including safety assessments and efficacy endpoints, and apply it to inform decision-making. Demonstrated leadership skills with the ability to collaborate effectively with cross-functional teams and external stakeholders. Demonstrated excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings. Ability to develop relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs). Familiarity with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus. Ability to travel to clinical sites, conferences, and regulatory meetings as needed. Fluent in English, verbal and written communication Additional Information: Travel 10-15% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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!

Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. to support new cardiovascular clinical trials Job Summary The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations. Responsibilities: Ongoing support of TIMI investigators with all phases of clinical research to include: Trial Initiation; Trial Coordination/Implementation/Maintenance and Trial Close-out. Trial Initiation: Assist in development of trial protocol IRB application and submit to appropriate authority; prepare and/or review budgets, as required; coordinate and work with ancillary departments/services as needed to successfully execute protocol elements; develop plan for site initiation once IRB protocol approval is received. Trial Coordination/Implementation: Conduct medical record screening of BWH cardiovascular in-patients and out-patients to identify eligible potential trial subjects; be prepared to approach potential subjects, and/or family members with trial specific information for review/consideration; assist in the recruitment of qualified/interested trial participants; maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow-up trial visits; obtain and process biological samples according to protocol (after completing any necessary training); co-manage with pharmacy all trial medications, including receipt and delivery of same; perform data entry for trials using both manual and electronic data capture; submit all study documentation in a timely manner to appropriate data management and core laboratories; submit any amendments to protocol, or informed consent form(s), to the IRB for review & approval; notify sponsors and IRB of all pertinent AEs (Adverse Events) and SAEs (Severe Adverse Events); perform other procedures related to the trial protocol; review completeness and quality of data with trial monitors; apprise the Principal Investigator and co-investigator(s) on a daily basis, as needed, of overall trial progress to include: subject enrollment, subject scheduling, issues/problems as they develop, subject retention and lost to follow-up metrics. Also, submit/track/amend annual protocol Continuing Reviews to the IRB; serve as an informed resource for trial participants and their families; educate ancillary staff and departments regarding trial protocols: develop trial materials as needed; and orient and train new staff. Trial Close-out: Assist with preparation and submission of final trial report to the IRB for review. Prepare all documents/files/binders/electronic data for sponsor-initiated or FDA audits. Other: Maintain department service standards as outlined in the BWH Code of Conduct. Perform other duties as required. Qualifications - External 1. Bachelor's Degree 2. Three to five years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred 3. Knowledge of federal and institutional policies governing human clinical research 4. Proficiency with PCs and windows-based software, including Word, Excel and data management system * Be fluent in English and Spanish (preferred) * Excellent interpersonal skills and ability to work effectively in team environments. * Strong organizational skills with ability to multi-task * Possess good judgment skills with ability to interpret information and protocol requirements, and initiate appropriate actions * Superior written and oral communication skills, to enable working with individuals from various fields of expertise and with trial subjects from various educational/cultural backgrounds * Accomplished documentation skills with meticulous attention to detail * Ability to complete tasks with aggressive deadlines and competing priorities * Ability to safeguard confidential information. * Comfortable with hospital in-patient and out-patient environments EEO Statement Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Clinical Research or Compliance experience 3-5 years required Knowledge, Skills and Abilities * Exceptional time management and organization skills. * Excellent written and verbal communication skills. * Knowledge of current and developing clinical research trends. * Sound interpersonal skills and the ability to mentor others. * Ability to identify problems and develop solutions. * Demonstrated ability to successfully manage multiple projects. Additional Job Details (if applicable) Remote Type Onsite Work Location 350 Longwood Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

The Department of Psychiatry and Behaviroal Sciences is seeking a full-time Senior Clinical Research Coordinator (Sr. CRC) for the Glahn Laboratory and Early Psychosis Investigation Center (EPICenter) at Boston Children's Hospital. This position is integral to a multidisciplinary team of healthcare professionals (researhcers and clinicians) dedicated to advancing research and treatment focused on children and adolescents with psychotic and affective disorders. By focusing on early onset psychiatric diagnoses, we aim to identify the root causes of psychiatric symptoms, and to improve treatment options and outcomes for patients and their families. The Sr. CRC will play a vital role in overseeing daily operations of multiple NIH-funded and foundation-funded studies aligned with these aims.Responsibilities include, but are not limited to: developing and implementing best practices for clinical research protocols; collaborating with the Principal Investigator to manage studies; supervising and train research staff; monitor regulatory compliance to uphold hospital and governmental standards. Our ideal candidate is committed to a long-term tenure with the Glahn Lab and brings at least four years of experience in research study design, management, and coordination. Key Responsibilities * Providing strategic oversight of a research portfolio with minimal supervision. Leading the development and implementation of clinical research projects in collaboration with Principal Investigator and/or designees to ensure targets are met on time. * Developing and implementing enrollment strategies and study documents, including IRB approved research protocols and study materials. Provide analytical, data management, and methodological support in the development of clinical research protocols and data management tools. Assist in the establishment of best practice guidelines for various clinical research protocols. * Desigining comprehensive training curriculum for research support staff and overseeing training and development initiatives. Supervise the day-to-day activities of research support personnel. * Oversee the consent and enrollment process for research study participants. Communicates all relevant policies and procedures to address participation inquiries. Evaluate the suitability and selection of prospective study candidates based on clinical knowledge. * Developing study-specific data management and quality assurance procedures, and ensure compliance at site visits and through periodic review of study data. * Potentially assist in writing grants and preparing new applications for research funding and in implementation and managing ancillary study grants. Minimum Requirements Education * A Bachelor's degree in psychology or related field, with a minimum of 4 years relevant work experience, OR Master's Degree and 2 years relevant work experience * A cover letter describing your interest in the position and articulating why you would be an excellent fit for the Glahn Lab is preferred. Experience * Strong attention to detail and organizational skills * Exceptional communication skills to convey critical information, work collaboratively on a team, and resolve conflicts effectively * Exemplary interpersonal and supervisory skills, to lead by example and mentor research support staff and to foster collaboration within the research team * Ability to manage complex data collection procedures training * Oversee participant interview covering clinically sensitive subject matter * Flexiblity to accomandate a varied schedule, including some evenings and weekends * Willingness to commit long-term to this role 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.

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. Under the general direction of the Principal Investigator and Research Nurse Manager, the Senior Clinical Research Coordinator serves as a lead team member, subject matter expert and trial coordinator. Designs, implements, and coordinates both industry and physician sponsored research trials. This includes acting as a liaison between the Principal Investigator, clinical collaborators, the study sponsor, clinical trial regulatory groups (IRB, FDA, etc.), and other research staff to ensure adherence to the study protocols. Implements the research protocol through study closeout and ensures data validation, regulatory compliance, and quality control. Experience: A minimum of 3-5 years of clinical research experience is required. Computer proficiency in MS Excel, Word, Outlook, Teams required. Experience with multi-center study protocols required. Physician initiated (IDE or IND) trial experience preferred. Some direct experience working with the FDA on clinical trial audits is preferred. Working Conditions: - Office conditions: Fully onsite (to be available for study procedures). There is some travel between sites but will be mainly associated with the Boston hospital campus and 125 Nashua St. The office is temporarily moved to 125 Nashua St. Normally we sit in Boston main campus in the Edwards building. - May be required to work in clinical conditions (including the operating room). - May be exposed to minimal radiation. - May be required to attend meetings outside of regularly scheduled hours and locations, including domestic travel - On call schedule (dependent on enrolling trials) may be required. - May be requested to lift files/medical devices (less than 20 pounds). Job Summary Summary Working independently and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Additionally, provide input into determining study subject suitability, input into recruitment strategy, methodology design, statistical analyses, protocol design, and manuscript writing. Does this position require Patient Care? No Essential Functions -Independently determines the suitability of study subjects. -Develops and implements recruitment strategies. -Participates in the design of research methodology. -Plans, performs, and designs statistical analyses. -Recommends protocol changes, writes protocols, and contributes to manuscripts. -Independently performs specialized projects. Qualifications Education Bachelor's Degree Related Field of Study required or Graduate Diploma Related Field of Study preferred Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Related post-bachelor's degree research experience 3-5 years required Knowledge, Skills and Abilities - Ability to work more independently and as a team member. - High degree of computer literacy and analytical skills. - Ability to identify both technical and non-technical problems and develop solutions. - Ability to interpret acceptability of data results. - Highly proficient data management skills and working knowledge of data management systems. - Able to display initiative to introduce innovations to research study. - Excellent time management, organizational, interpersonal, written, and verbal communication skills. Additional Job Details (if applicable) Remote Type Onsite Work Location 125 Nashua Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 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.

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.