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clinical research associate

Alira Health

<div><p><b>Are you being referred to one of our roles by a connection in Alira Health? </b>If so, please apply using the referral link emailed to you.</p><p></p><p>
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don&rsquo;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.</p><p></p><p><b>
Job Description Summary</b></p>
The Lead CRA is an important member of the Alira Health Clinical team. The Lead CRA provides oversight, leadership, and guidance in the management and execution of clinical trial monitoring to ensure compliance and quality. Lead CRAs work closely with the Director of Clinical Monitoring, CRAs, CTCs and Clinical Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.<p></p><p><b>
Job Description</b></p><h2 class="jobSectionHeader"><b>
THE LEAD CLINICAL RESEARCH ASSOCIATE ROLE</b></h2><p></p><h3 class="jobSectionHeader"><b>
ESSENTIAL JOB FUNCTIONS*</b></h3><ul><li><p>
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work, Alira Health SOPs and regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.</p></li><li><p>
May perform Central Monitoring activities, or act as the primary liaison between site and Central Monitor.</p></li><li><p>
Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct.</p></li><li><p>
Exhibits meticulous care in upholding the privacy of all subjects/participants.</p></li><li><p>
Escalates quality issues or trends appropriately per the escalation pathway.</p></li><li><p>
Conducts investigational product (IP) inventory and accountability, while evaluating storage conditions and access protocols. Confirms IP has been dispensed and administered to participants in compliance with the study protocol. Leverages expertise in GCP, local regulations and Alira Health procedures to ensure IP is properly labeled, relabeled, transported, released, returned or destroyed.</p></li><li><p>
Reviews the Investigator Site File (ISF) for audit readiness including accuracy and completeness. Reconciles the ISF with the Trial Master File (TMF), ensuring filing of essential documents in accordance with local guidelines and regulations.</p></li><li><p>
Performs quality checks on regulatory documents per ALCOA+ principles, collecting copies for TMF filing. Supports audit readiness by submitting documents to the TMF, utilizing the filing index and medidata as necessary.</p></li><li><p>
Verification and review of safety events (AE/SAE/UADE/AESI, etc) including reconciliation of concomitant medications and medical history to confirm accurate reporting in accordance with the protocol, local regulations and regulations.</p></li><li><p>
Prepares accurate monitoring visit reports and communication logs in alignment with Alira Health SOPs and the Clinical Monitoring Plan timelines. Reports detail site-specific concerns, follow-up tasks, corrective actions, protocol deviations and violations, enrollment progress and safety events collected.</p></li><li><p>
Participates in internal, client/sponsor, scientific, and other meetings as required.</p></li><li><p>
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.</p></li><li><p>
Assists in set up/collection of site-specific ethics documents and site contract negotiation.</p></li><li><p>
Provides monthly billing information to finance team as required.</p></li><li><p>
For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.</p></li><li><p>
Provides monthly billing information to the finance and project management team, as needed.</p></li><li><p>
Performs CRA training and mentoring to more junior level CRAs.</p></li><li><p>
May co-monitor and perform Evaluation Visits for more junior level CRAs.</p></li><li><p>
Provides guidance, oversight, and feedback to the study team to ensure adherence to project scope, study plans, timelines, and budget requirements.</p></li><li><p>
Oversees Clinical Research Associates (CRAs) to ensure monitoring visits are conducted within the timelines specific in the Clinical Monitoring Plan or adjusted as necessary to align with the project requirements. Monitors site and CRA performance to maintain SDV rates within study goal range, directing CRAs to perform additional visits when thresholds are not met.</p></li><li><p>
Oversees CRAs in the execution of ongoing site management activities, including reviewing Electronic Data Capture (EDC) queries, resolving follow-up items and responding to site staff inquiries in a timely manner.</p></li><li><p>
Can serve as a line manager with direct reports, with accountability for CRA annual performance reviews, continued career progression, Key Performance Indicators (KPIs) and study/site assignments.</p></li><li><p>
Ensure CRAs are working with sites to drive, track and report on subject recruitment in line with project needs and expectations.</p></li><li><p>
Provide protocol and study related training to assigned CRA and establish regular lines of communication to manage ongoing project expectations and issues.</p></li><li><p>
Evaluate the quality and integrity of CRA performance through monitoring visit report review. Review will ensure evidence of adequate CRA oversight and site management per the Clinical Monitoring Plan (CMP), Alira Health SOPs and ICH GCP. Specifically, adequate oversight of IP and accountability, routine review of ISF and audit readiness, clear and adequate reporting of protocol deviations, ensuring resolve of follow-up items in a timely manner and study compliance by the site staff and PI. Trends are shared with the Project Manager and escalated to the Sponsor as necessary.</p></li><li><p>
Evaluate the quality and integrity of CRA performance through metric tracking. Specifically, tracking EDC query resolution and follow-up issue duration. Trends are shared with the Project Manager and escalated to the Sponsor as necessary.</p></li><li><p>
Maintains oversight and accountability of monitoring visit reports, ensuring CRAs submit the draft, and the report is finalized within the Alira Health SOP and CMP timelines. Responsible for tracking study specific metrics, sharing with the Project Manager and escalating to the Director of Clinical Monitoring as needed.</p></li><li><p>
Consistently reviews monitoring visit reports within the Alira Health SOP and CMP timelines.</p></li><li><p>
Works closely with Project Managers, CRAs and Data Management to resolve CRF queries on discrepant data.</p></li><li><p>
Collaborates with development, maintenance and training of the Clinical Trial Management System (CTMS) and Trial Master File (TMF).</p></li><li><p>
Prepares for, attends and presents during Investigator Meetings.</p></li><li><p>
Conducts project specific CRA meetings and trainings.</p></li><li><p>
May be mentored and assigned Project Management, or other operational tasks, under the supervision of an experienced team member.</p></li><li><p>
Assists in resourcing planning for upcoming and ongoing clinical trials.</p></li><li><p>
Can support hiring potential new employees.</p></li><li><p>
Can be responsible for CRA new hire training and onboarding.</p></li><li><p>
Can conduct review of CRA timesheet reporting.</p></li><li><p>
May participate and present in bid defense meetings.</p></li><li><p>
May participate in audits and associated meetings, including preparation at study sites as needed.</p></li><li><p>
Collaborates with study team members for project execution and performs additional duties and tasks as assigned.</p></li></ul><h2 class="jobSectionHeader"><b>
PREPARATION, KNOWLEDGE, SKILLS &amp; ABILITIES</b></h2><ul><li><p>
Dedicated and results oriented with a bachelor&rsquo;s degree in a relevant field (sciences, nursing, medical preferred).</p></li><li><p>
Preferred 7+ years&rsquo; experience in the clinical research or health industry fields. Clinical monitoring experience required in the pharmaceutical, biotech, medtech or CRO industries. People and study management experience required.</p></li><li><p>
Expertise in data management, site management and monitoring, including proficiency in clinical trial software and tools.</p></li><li><p>
Committed to quality with a proven track record of being thorough and detail-oriented in ensuring protocol adherence and data integrity.</p></li><li><p>
Excels in organizational and time management skills, enabling effective multitasking in fast-paced environments while managing priorities, organizing time efficiently, and solving complex problems.</p></li><li><p>
Possess strong analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills to drive successful trial outcomes.</p></li><li><p>
Willing and able to travel up to 85% to support site visits and project needs.</p></li><li><p>
Professional, trustworthy, and disciplined self-starter who thrives in collaborative team settings, fostering a positive and productive atmosphere.</p></li><li><p>
In-depth knowledge of ICH GCP and ISO 14155 guidelines, along with local regulatory requirements.</p></li><li><p>
Skilled at establishing and maintaining positive relationships with sponsors, investigative sites, and cross-functional project teams to facilitate seamless communication and achieve study milestones.</p></li><li><p>
Experience in people and study management.</p></li><li><p>
Strong command of English, and the local language as necessary, both written and verbal.</p></li></ul><p></p><h2 class="jobSectionHeader"><b>
WORKING CONDITIONS/PHYSICAL DEMANDS</b></h2><p>
Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.</p><p></p><p>
Compensation: $130,000 - 155,000 commensurate with experience</p><p></p><p><b>
Languages</b></p>
English<p></p><p><b>
Education</b></p>
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy<p></p><p><b>
Contract Type</b></p>
Regular</div>

Lead Clinical Research Associate

AbbVie

<div><b>Company Description</b><p><b><br>
About AbbVie</b></p><p>
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.</p><b><br>
Job Description</b><p><br>
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance.<br>
Partners with study teams, AbbVie internal R&amp;D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials.<br>
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.</p><p><b>
Responsibilities:</b></p><p>
Considered as the Primary Sponsor Point of contact for the investigative site. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning. Ability to motivate and align monitoring community through leadership and mentorship.</p><ul><li>
Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able to support, guide, and mentor junior personnel on Site Management activities.</li><li>
Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li><li>
Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.</li><li>
Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li><li>
Possesses advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.</li><li>
May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li><li>
Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li><li>
Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li><li>
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.</li></ul><p></p><ul><li><br>
<b>This is a remote position. Candidates must be based in MA and be willing to travel for site visits.</b></li></ul><b><br>
Qualifications</b><br>
<ul><li>
Education: Bachelor&rsquo;s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).</li><li>
Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.</li><li>
Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials</li><li>
Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li><li>
Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders.</li><li>
Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li><li>
Superior ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li><li>
Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li><li>
Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues</li><li>
Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</li></ul><br>
<b>
Additional Information</b><p><br>
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
</p><ul><li><p>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographiclocation, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</p></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</p></li><li><p>This job is eligible to participate in our short-term incentive programs.
</p></li></ul><p>Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.</p><div></div><p>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.</p><p>
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</p><p>
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><p>
https://www.abbvie.com/join-us/reasonable-accommodations.html</p></div>

Senior Clinical Research Associate

IQVIA

<div><div><div>Boston, United States of America | Full time | Field-based | R1535029</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><b><br>
IQVIA is hiring Senior Clinical Research Associate 1 </b>with experience in either oncology, cardiovascular, renal, metabolic, CNS, Obesity (GLP-1), diabetes, GI, MASH/NASH, dermatology, or respiratory:</div><div><b>
Job Overview:
</b></div><div>Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.</div><div><b>
Key Responsibilities:
</b></div><ul><li>Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.</li><li>Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.</li><li>Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.</li><li>Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.</li><li>Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.</li><li>Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.</li><li>Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.</li></ul><div>
&bull; Collaborate and liaise with study team members for project execution support as appropriate. Responsibilities Essential Functions &bull; If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.</div><ul><li>If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.</li></ul><div><b>
Qualifications:</b></div><ul><li>Bachelor's Degree in scientific discipline or health care preferred.</li><li>Requires at least 2 years of year of on-site monitoring experience.</li><li>Equivalent combination of education, training and experience may be accepted in lieu of degree.</li><li>Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.</li><li>Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.</li><li>Good therapeutic and protocol knowledge as provided in company training.</li></ul><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div>
The potential base pay range for this role, when annualized, is $101,600.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div></div><div></div>

Sr. Clinical Research Associate, IQVIA

<div><p><b>Are you being referred to one of our roles by a connection in Alira Health? </b>If so, please apply using the referral link emailed to you.</p><p></p><p>
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don&rsquo;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.</p><p></p><p><b>
Job Description Summary</b></p><p></p><p><b>
Job Description</b></p><h2 class="jobSectionHeader"><b>
ROLE</b></h2><p>
The In-house CRA is an important member of the Alira Health Clinical team. In-house CRAs manage and support clinical sites from site approval through close-out. In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel.</p><p></p><h2 class="jobSectionHeader"><b>
KEY RESPONSABILITIES</b></h2><ul><li><p>
Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc.</p></li><li><p>
Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs</p></li><li><p>
Responds to sites&rsquo; regulatory board requests for protocol and ICF clarification as needed</p></li><li><p>
Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment</p></li><li><p>
Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews</p></li><li><p>
Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites</p></li><li><p>
Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests</p></li><li><p>
Conducts remote review of data entered on electronic Case Report Forms (eCRFs)</p></li><li><p>
Works closely with field CRAs and data management to resolve queries on discrepant data</p></li><li><p>
Assists with efforts to recruit investigative sites to participate in clinical studies</p></li><li><p>
Complies with ICH GCP guidelines, FDA regulations, and company SOPs</p></li><li><p>
Participates in internal, client/sponsor, scientific, and other meetings as required</p></li><li><p>
Manages and resolves conflicting priorities to deliver on commitments</p></li><li><p>
Performs additional duties as assigned</p></li></ul><p></p><h2 class="jobSectionHeader"><b>
DESIRED QUALIFICATION &amp; EXPERIENCE</b></h2><ul><li><p>
BS/BA from an undergraduate program or equivalent experience</p></li><li><p>
1-2 years of experience in clinical research</p></li></ul><p></p><h2 class="jobSectionHeader"><b>
TECHNICAL COMPETENCES &amp; SOFT SKILLS</b></h2><ul><li><p>
Proven ability to be careful, thorough, and detail-oriented</p></li><li><p>
Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment</p></li><li><p>
Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills</p></li><li><p>
Self-starter who thrives in a collaborative, yet less structured team environment</p></li><li><p>
Ability to problem-solve unstructured or ambiguous challenges</p></li><li><p>
Strong command of English, both written and verbal</p></li><li><p>
Excellent communication and interpersonal skills with customer service orientation</p></li><li><p>
Proficient with MS Office Suite, particularly Word and Excel</p></li><li><p>
Permanent authorization to work in the U.S.</p></li></ul><p></p><p>
Compensation $85,000 - 100,000 commensurate with experience</p><p></p><p><b>
Languages</b></p>
English<p></p><p><b>
Education</b></p>
Bachelor of Arts (BA), Bachelor of Science (BS)<p></p><p><b>
Contract Type</b></p>
Regular</div>

In house clinical research associate

The General Hospital Corporation

<div>Site: The General Hospital Corporation<p></p><p><br>
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.</p><p></p><p><b><br>
Job Summary</b></p>
The Cancer Outcomes Research and Education (CORE) Program at the Mass General Brigham Cancer Institute is recruiting a full-time Clinical Research Associate (CRA) to join its multidisciplinary team. Working with oncologists, palliative care clinicians, psychiatrists, psychologists, advanced practice nurses, and other specialists, the CRA will support CORE&rsquo;s digital health initiatives as well as program-wide communications and outreach efforts. The focus of this position is to assist with the coordination and implementation of digital health research projects while also contributing to communication, dissemination, and development-related materials for the CORE Program. This role emphasizes digital health project support, content development, and external-facing communications.<p></p><div><div><div><div><div><div><div><p><b><br>
Qualifications</b></p></div></div></div></div></div></div></div><p>
Education<br>
Bachelor's Degree Related Field of Study required</p><p><b>
Responsibilities</b></p><p>
The CRA will support digital health research projects and CORE Program&ndash;wide communications initiatives.</p><p></p><p><b>
Please complete online application and upload both a Cover Letter and resume.</b></p><p></p><p>
Responsibilities include:</p><p></p><p><b>
Digital Health Project Support</b></p><ul><li>
Managing and maintaining working knowledge of CORE digital health initiatives and procedures</li><li>
Assisting with the development, deployment, and maintenance of digital health interventions (e.g., mobile applications, web-based platforms, tablets, and other digital tools) in collaboration with investigators and technical partners</li><li>
Coordinating digital content development, standardization, version control, and archiving</li><li>
Working with investigators, project managers, and external collaborators or vendors on digital health project implementation</li><li>
Supporting management of digital health equipment and materials and assisting with training on appropriate use</li><li>
Assisting with literature reviews and supporting data management and quality assurance activities related to digital health projects</li></ul><p></p><p><b>
CORE Program Communications and Development Support</b></p><ul><li>
Assisting with maintenance and updates of the CORE Program website and digital presence</li><li>
Developing and updating CORE Program materials, including study descriptions, recruitment materials, and program summaries</li><li>
Assisting with preparation of materials for development and philanthropy efforts, such as impact summaries, donor-facing materials, and program overviews</li><li>
Supporting preparation of abstracts, manuscripts, presentations, and grant-related materials across CORE initiatives</li><li>
Coordinating communications, meetings, and outreach activities related to CORE Program initiatives</li><li>
Collaborating closely with CORE investigators, research staff, administrative staff, and institutional partners on program-level initiatives</li><li>
Completing other program-related projects as assigned by principal investigators and CORE leadership</li></ul><p></p><div><div><div><div><div><div><div><p><b><br>
Additional Job Details (if applicable)</b></p></div></div></div></div></div></div></div><p><b>
Qualifications</b></p><p></p><p><b>
Minimum Education</b></p><ul><li>
Bachelor&rsquo;s degree required</li></ul><p></p><p><b>
Preferred Fields of Study</b></p><ul><li>
Public Health</li><li>
Psychology or Behavioral Science</li><li>
Health Informatics or Digital Health</li><li>
Computer Science, Information Science, or related technical field</li><li>
Communications, Media, or Health Communication</li><li>
Other related fields with demonstrated interest in research, digital health, and/or health communication</li></ul><p></p><p><b>
Required Skills and Attributes</b></p><ul><li>
Strong organizational skills with the ability to manage multiple priorities and deadlines</li><li>
Excellent written and verbal communication skills</li><li>
High attention to detail and ability to follow established procedures</li><li>
Comfort working independently while collaborating within a multidisciplinary team</li><li>
Strong interpersonal skills and professionalism</li><li>
Proficiency with standard computer applications (e.g., Microsoft Office, Google Workspace) and willingness to learn new platforms and tools</li></ul><p></p><p><b>
Preferred (but Not Required) Experience</b></p><ul><li>
Interest in or exposure to digital health, technology-enabled interventions, or user-facing digital tools</li><li>
Experience with websites, digital content management, or communications and development materials</li><li>
Familiarity with research environments or project coordination</li></ul><p></p><p>
This position is well suited for individuals seeking experience at the intersection of clinical research, digital health, communications, and program development.</p><p></p><div><div><div><div><div><div><div><p><b><br>
Remote Type</b></p></div></div></div></div></div></div></div>
Onsite<p></p><div><div><div><div><div><div><div><p><b><br>
Work Location</b></p></div></div></div></div></div></div></div>
55 Fruit Street<p></p><div><div><div><div><div><div><div><p><b><br>
Scheduled Weekly Hours</b></p></div></div></div></div></div></div></div>
40<p></p><div><div><div><div><div><div><div><p><b><br>
Employee Type</b></p></div></div></div></div></div></div></div>
Regular<p></p><div><div><div><div><div><div><div><p><b><br>
Work Shift</b></p></div></div></div></div></div></div></div>
Day (United States of America)<p></p><p><b><br>
Pay Range</b></p>
$20.16 - $29.01/Hourly<p></p><p><b><br>
Grade</b></p>
5<br>
<p></p>
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.<p></p><div><div><div><div><div><div><div><p><b><br>
EEO Statement:</b></p></div></div></div></div></div></div></div>
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&rsquo;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 (857)-282-7642.<p></p><h2 class="jobSectionHeader"><b><br>
Mass General Brigham Competency Framework</b></h2><div><div><p>
At Mass General Brigham, our competency framework defines what effective leadership &ldquo;looks like&rdquo; 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.</p></div></div></div>

Digital Health Clinical Research Associate I

Dana-Farber Cancer Institute

<div><div><div><div>Job Ref:</div><div>
JR-2532</div></div><br>
<div><div>Location:</div><div>
450 Brookline Ave, BOSTON, MA 02215</div><br>
</div>
<div><div>Category:</div><div>
Clinical Research</div></div><br>
<div><div>Employment Type:</div><div>
Full time</div></div><br>
<div><div>Work Location:</div><div>
Onsite: 100% onsite</div></div><br>
<div></div><div><div>Salary/Pay Rate:</div><div>
$48,100.00 - $54,400.00 per year</div>
</div></div><p><b>Overview</b></p>
<p></p><div><div>The Center for Detection and Interception Blood Cancers is hiring a Clinical Research Coordinator to support non-interventional studies such as biobanking and observational studies. The CRC (Clinical Research Coordinators) work within 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.<br>
<br>
This position is considering 2026 bachelor&rsquo;s degree graduates.<p>
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.</p><br>
<ul><li>
Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities</li><li>
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</li><li>
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</li><li>
Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations</li><li>
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</li><li>
Responsible for organizing and preparing for both internal and external auditing and study monitoring visits</li><li>
Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities</li><li>
Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved</li><li>
Interact with study participants as directed/required by the protocol and/or study team</li><li>
May be responsible for tissue sample collection per trial requirements</li></ul><p><b>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:</b></p><ul><li>
Excellent organization and communications skills required</li><li>
Strong interpersonal skills &ndash; ability to effectively interact with all levels of staff and externals contacts</li><li>
Must be detail oriented</li><li>
Ability to effectively manage time and prioritize workload</li><li>
Must practice discretion and always adhere to hospital confidentiality guidelines</li><li>
Must have computer skills including the use of Microsoft Office</li></ul><p></p><p><b><br>
MINIMUM JOB QUALIFICATIONS:</b></p><p>
Bachelor&rsquo;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.</p><p><b><br>
</b></p><p><b>SUPERVISORY RESPONSIBILITIES:
</b></p><p>None</p><p><b>
PATIENT CONTACT:
</b></p><p>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.</p><p>
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 .</p><p>
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.
</p><h3 class="jobSectionHeader"><b>EEO Poster</b></h3>
.<p>
Pay Transparency Statement</p><p>
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&rsquo;s relevant experience, skills and qualifications.</p><p>
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).</p>
$48,100.00 - $54,400.00</div></div></div><p></p>

Clinical Research Coordinator - Center for Early Detection and Interception Blood Cancers

<div><div><div><div>Job Ref:</div><div>
JR-2522</div></div><br>
<div><div>Location:</div><div>
450 Brookline Ave, BOSTON, MA 02215</div><br>
</div>
<div><div>Category:</div><div>
Clinical Research</div></div><br>
<div><div>Employment Type:</div><div>
Full time</div></div><br>
<div><div>Work Location:</div><div>
Onsite: occasional remote</div></div><br>
<div></div><div><div>Salary/Pay Rate:</div><div>
$48,100.00 - $54,400.00 per year</div>
</div></div><p><b>Overview</b></p>
<p></p><div><div>The CRC (Clinical Research Coordinators) work within 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.<p>
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.</p><br>
<ul><li>
Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.</li><li>
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.</li><li>
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.</li><li>
Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations.</li><li>
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.</li><li>
Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.</li><li>
Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities.</li><li>
Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.</li><li>
Interact with study participants as directed/required by the protocol and/or study team.</li><li>
May be responsible for tissue sample collection per trial requirements.</li><li>
Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.</li><li>
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.</li><li>
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.</li></ul><p><b>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:</b></p><ul><li>
Excellent organization and communications skills required.</li><li>
Strong interpersonal skills &ndash; ability to effectively interact with all levels of staff and externals contacts.</li><li>
Must be detail oriented and have the ability to follow-through.</li><li>
Ability to effectively manage time and prioritize workload.
</li><li>Must practice discretion and adhere to hospital confidentiality guidelines at all times.</li><li>
Must have computer skills including the use of Microsoft Office.</li></ul><p><b>
MINIMUM JOB QUALIFICATIONS:
</b></p><ul><li>Bachelor&rsquo;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.
</li></ul><p><b>SUPERVISORY RESPONSIBILITIES: None</b></p><p><b>
PATIENT CONTACT:
</b></p><p><b>All positions: </b>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</p><p>
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 .</p><p>
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.
</p><h3 class="jobSectionHeader"><b>EEO Poster</b></h3>
.<p>
Pay Transparency Statement</p><p>
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&rsquo;s relevant experience, skills and qualifications.</p><p>
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).</p>
$48,100.00 - $54,400.00</div></div></div><p></p>

Clinical Research Coordinator - Breast Oncology

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