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clinical research manager

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>
Summary<br>
Responsible for managing a clinical study involving multiple sites around the world. Leading the efforts on selecting the sites, testing the sites capabilities to ensure long-term compliance, engaging in contractual agreements with the sites, working together with the department to manage the execution of the site agreements, training the staff at each site with respect to the study protocol and data upload to the web-based data collection system. Responsible for the generation of standard operating procedures; works directly with investigators, clinicians, software developers and other lab personnel.
<br>
<br>
Does this position require Patient Care?<br>
No<br>
<br>
Essential Functions<br>
<ul><li>Engages potential sites and tests their capabilities for long-term compliance.
</li><li>Trains the site coordinators at each clinical site.
</li><li>Monitors the site coordinators at each clinical site.
</li><li>Trains newly hired technical staff to work on this project.
</li><li>Responsible for the generation and maintenance of standard operating procedures.
</li><li>Responsible for communicating project progress with the sponsor.
</li><li>Responsible for troubleshooting problems related to access the web based registry.
</li><li>Prepares reports and presents progress at research staff meetings.</li></ul><p></p><div><div><div><div><div><div><div><p><b><br>
Qualifications</b></p></div></div></div></div></div></div></div><div>
Education<br>
Bachelor's Degree Related Field of Study required<br>
<br>
Can this role accept experience in lieu of a degree?<br>
No<br>
<br>
Licenses and Credentials<br>
<br>
Experience<br>
Research Related Experience 3-5 years required<br>
<br>
Knowledge, Skills and Abilities<br>
<ul><li>Excellent critical thinking skills and ability to work independently are essential.</li><li>Must be self-motivated and able to work independently.</li><li>Good verbal and written communication skills.</li><li>Proficiency in Word, Power point, Excel.</li><li>Ability to make independent effective decisions.</li><li>Strong organizational skills.</li><li>Demonstrated analytical skills to problem solve effectively.</li></ul></div><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></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>
$78,936.00 - $126,401.60/Annual<p></p><p><b><br>
Grade</b></p>
8<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>

Clinical Research Program Manager

Tufts Medical Center

<div><div><div><p><b>Job Profile</b><b> Summary</b></p></div><div><p>
This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. A senior level role that requires advanced knowledge of job area typically obtained through advanced education and work experience. Typically responsible for: managing projects / processes, working independently with limited supervision, coaching and reviewing the work of lower level professionals, resolving difficult and sometimes complex problems.</p></div><p></p><p><b>
Job Overview</b></p></div><div><p><b>
The Center for Clinical Trials at Tufts CTSI and Tufts Medical Center is </b><b>an academic data coordinating center supporting investigator-initiated multisite clinical </b><b>trials. The Clinical Research Data Manager I will be an integral member of the data </b><b>management team, working closely with principal investigators, senior data manager, </b><b>project managers, and biostatisticians to support the operationalization of clinical trial </b><b>protocols into high-quality electronic data systems. </b><b>This role requires hands-on proficiency with REDCap and core clinical trial data </b><b>management workflows. The Data Manager will work within established data </b><b>coordinating center processes to support protocol-driven database design, REDCap </b><b>EDC build and testing (including branching logic, calculated fields, and automated </b><b>notifications), and ongoing data quality control activities. The position emphasizes </b><b>rigorous execution, attention to detail, and accountability for assigned day-to-day data </b><b>management tasks, including supporting query resolution, data cleaning, and assisting </b><b>with the preparation of analysis-ready datasets in compliance with GCP and institutional </b><b>standards.</b></p></div><p></p><div><p><b><br>
Minimum Qualifications</b><b>:</b></p></div><div><p>
1. Bachelor&rsquo;s degree in health science, public health, epidemiology, or another related field including coursework in biostatistics or computerized analytic techniques.</p></div><div><p>
2. Three (3) years of experience as a clinical data manager including developing relational databases for clinical studies using REDCap and/or commercially available EDC systems.</p></div><p></p><div><p><b><br>
Preferred Qualifications</b><b>:</b></p></div><div><p>
1. Experience assisting in the build and management of REDCap databases
</p><p>2. Experience translating protocols into schedules of events, CRFs, and database specifications<br>
3. Experience supporting data quality control, query generation and resolution, and database cleaning and lock, under supervision
</p><p>4. Experience assisting with the preparation of analysis-ready datasets and collaborating closely with biostatisticians</p></div><p></p><div><p><b><br>
Duties and Responsibilities</b><b>:</b> The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.</p></div><p></p><div><p><br>
1. Develops Electronic Case Report Forms, eCRF completion guidelines and edit checks, and trial Data Management Plans.</p></div><div><p>
2. Communicates with trial site staff regarding data submission and the resolution of data queries, and performing descriptive statistical analyses.</p></div><div><p>
3. Leads daily data activities for assigned studies.</p></div><div><p>
4. Designs, develops, tests, validates, and manages Web-based EDC systems to support study outcomes.</p></div><div><p>
5. Writes and implements data management plans, data entry guidelines, and data completion guidelines in compliance with Standard Operating Procedures, Good Clinical Practice (GCP) guidelines, and FDA requirements, if applicable.</p></div><div><p>
6. Supports clinical research reporting for data review, quality-control edit checks, and interim and final analyses.</p></div><div><p>
7. Completes database cleaning and database locks, and assisting research biostatisticians with analysis file creation and statistical analyses.</p></div><div><p>
8. Provides educational support and training to investigators and study site coordinators for the development and implementation of research studies.</p></div><div><p>
9. Mentors data management/entry staff and providing project management support.</p></div><div><p>
10. Serves as credible expert/leader for data management best practices.</p></div><div><p>
11. Establishes priorities and strategies for resource development and core goal setting.</p></div><div><p>
12. Provides positive and effective customer service and contributing to teamwork within and between departments, divisions, programs and other organizations.</p></div><div><p>
13. Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.</p></div><p></p><div><p><b><br>
Physical Requirements</b><b>:</b></p></div><div><p>
1. This is largely a sedentary role, which involves sitting most of the time, but may involve movements such as walking, standing, reaching, ascending/descending stairs, and operating office equipment.</p></div><div><p>
2. Frequently required to speak, hear, communicate, and exchange information.</p></div><div><p>
3. Ability to see and read computer displays, read fine print, and/or normal type size print and distinguish letters, numbers and symbols.</p></div><div><p>
4. Requires manual dexterity using fine hand manipulation to operate computer keyboard.</p></div><p></p><div><p><b><br>
Skills &amp; Abilities:</b></p></div><div><p>
1. Analytical skills.</p></div><div><p>
2. Knowledge of, and high proficiency in, Electronic Data Capture (EDC) and industry data standards (e.g., CDISC).</p></div><div><p>
3. Proven capability of attention to detail and accuracy.</p></div><div><p>
4. Knowledge of GCP guidelines and FDA regulations.</p></div><div><p>
5. Ability to maintain positive and service-oriented culture under stress and deadlines.</p></div><div><p>
6. Flexible and able to adjust to shifting priorities in a fast-paced and dynamic work environment.</p></div><div><p>
7. Superior organizational skills: can prioritize and complete multiple simultaneous efforts with ease.</p></div><div><p>
8. Ability to work independently and as a part of a collaborative team.</p></div><div><p>
9. Knowledge of clinical and translational research.</p></div><div><p>
10. Proficiency in other data management and statistical software (e.g, SAS, SQL, web based EDC) is desirable.</p></div><p></p><p><br>
At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day.</p><p></p><p>
The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals.</p><p></p><p>
Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth&mdash;one of the many ways we invest in you so you can thrive both at work and outside of it.</p><p></p><p><b><br>
Pay Range</b><b>:</b></p><br>
<p></p>
$55,883.46 - $69,859.61</div>

Clinical Research Data Manager I

Beth Israel Lahey Health

Boston, MA &bull; Beth Israel Deaconess Medical Center &bull; Full-time &bull; Day
<br><div><p><b>When you join the growing BILH team, you're not just taking a job, you&rsquo;re making a difference in people&rsquo;s lives.</b></p>
<p></p>
<p>Responsible for screening research subjects for participation in clinical research projects, enrolling research subjects onto these studies, monitoring protocol implementation, completing required forms and reporting results. Works closely with other clinical research staff.</p>
<p></p>
<p><b>Job Description:</b></p>
<p><b>
Primary Responsibilities:</b></p>
<p>
1. Independently or in conjunction with other clinical research staff and/or research nurse, recruits and enrolls research subjects onto clinical research projects according to study protocols. May assess research subjects' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. (essential)</p>
<p>
2. Checks all eligibility and ineligibility criteria with the research subjects' medical record. Verifies information with clinical research nurse and/or principal investigator. (essential)</p>
<p>
3. Discusses informed consent with research subjects. Interacts with research subjects prior to entering the study and throughout the entire treatment. Assists with scheduling appointments and follow up tests. (essential)</p>
<p>
4. Learns protocol and monitors strict adherence to protocols by physicians, nurses and research subjects. Reviews protocol requirements with physicians, nurses and fellows. Identifies any problems with protocol compliance and notifies principal investigator and/or research nurse. Begins to learn how to independently resolve problems with protocol. (essential)</p>
<p>
5. Extracts data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols. Enters data into computerized system. (essential)</p>
<p>
6. Assists clinic staff in obtaining insurance approval for subject protocol participation and scheduling tests and arranging admissions or outpatient visits for subjects. (essential)</p>
<p>
7. Assists investigator with correspondence with IRB. (essential)</p>
<p></p>
<p><b>Required Qualifications:</b></p>
<ul>
<li><p>Bachelor's degree required.</p>
</li>
<li><p>0-1 year of related work experience required.</p>
</li>
<li><p>Medical terminology.</p>
</li>
<li><p>Working knowledge of computer systems required, including web-based applications and some Microsoft Office applications, which may include Outlook, Word, Excel, PowerPoint or Access.</p>
</li>
</ul><p><b>Competencies:</b></p>
<p><b>
Decision Making:</b> Ability to make decisions that are based on specific instructions, standard practices and established procedures which generally require little or no supervision.</p>
<p><b>
Problem Solving:</b> Ability to address problems that are routine, somewhat repetitive and generally solved by following clear directions and procedures and by identifying opportunities for process improvements.</p>
<p><b>
Independence of Action:</b> Ability to follow general instructions and procedures as provided. Work is monitored by supervisor/manager.</p>
<p><b>
Written Communications:</b> Ability to communicate clearly and effectively in written English with internal and external customers.</p>
<p><b>
Oral Communications:</b> Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.</p>
<p><b>
Knowledge:</b> Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.</p>
<p><b>
Teamwork: </b>Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.</p>
<p><b>
Customer Service:</b> Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.</p>
<p></p>
<p><b>Physical Requirements:</b><br>
Light work: Exerting up to 20 pounds of force frequently to move objects. Some elements of the job are sedentary, but the employee will be required to stand for periods of time or move throughout the hospital campus.</p><br>
<p></p>
<p></p>
<p><b>Pay Range:
</b></p><p>$19.23 &ndash; $28.37</p>
<p>
The pay range listed for this position is the base hourly wage range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law.</p>
<p></p>
<h2 class="jobSectionHeader"><b>As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition of employment.</b></h2>
<p></p>
<h2 class="jobSectionHeader"><b>More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.</b></h2>
<p></p>
<h2 class="jobSectionHeader"><b>Equal Opportunity Employer/Veterans/Disabled</b></h2></div><p></p>
<br><div><h3 class="jobSectionHeader"><b>Job details</b></h3>
<ul><li><div><b>Employment:</b> Full-time</div></li>
<li><div><b>Hours/Week:</b> 40</div></li>
<li><div><b>Shift:</b> Day</div></li>
<li><div><b>Category:</b> Medical/Clinical Research</div></li>
<li><div><b>Pay Range:</b> $19.23 - $28.37</div></li>
<li><div><b>FLSA:</b> Non-Exempt</div></li>
<li><div><b>Req ID:</b> JR92310</div></li></ul></div>

Clinical Research Coordinator – Stephenson Clinical Research

<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><br>
<p></p>
The Translational Clinical Research Associate/Clinical Research Coordinator works under general supervision to consent and enroll eligible patients to clinical translational research protocols and manage all aspects of data collection and requests. In particular, the CRA/CRC I will work on specimen collection studies. The Translational CRC/CRA will work closely with multiple providers to support their translational research projects. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact. This is an on-site/hybrid position. Duties will be performed primarily on-site in ambulatory/clinical office setting. Components of the data/regulatory role may allow for remote work.<br>
<br>
All duties will be performed under general supervision by the Clinical Research Manager.
<br>
<br>
The following clinical duties will be performed:
<br>
<br>
<ul><li>Interfacing in a professional manner with a diverse team of physicians, clinical research assistants, research nurses, pathologists and patients
</li><li>Coordinating the collection and processing of tissue samples and blood samples from patients
</li><li>Consent patients to translational research studies (minimal risk specimen collection studies)</li><li>Explain study protocol to patients and obtain informed consent</li><li>Screen and follow patients relevant to specific projects/studies
</li><li>Assist clinical team in screening potential patients for study participation</li><li>Schedule all protocol required tests and procedures
</li><li>Consent patients to specimen collection protocols</li><li>Coordinate patient appointments with physicians, nurses, and all test areas</li><li>Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers</li><li>Prepare pre-visit communication for providers to ensure required assessments are completed and documented</li><li>Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation</li><li>Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition</li><li>Coordinate, obtain, process, and ship protocol required blood and tissue samples
</li><li>Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL)</li></ul><br>
<br>
<br>
The following data management responsibilities will be performed:<br>
<br>
<ul><li>Collecting detailed clinical and treatment information on patients who are undergoing genetic testing, receiving treatments for cancer, or are enrolled in a research study</li><li>Maintaining an updated and organized database of patients
</li><li>Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
</li><li>Enroll patients as required by the study sponsor and internal enrollment monitor team
</li><li>Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
</li><li>Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
</li><li>Maintain research charts and/or electronic files for all enrolled patients</li><li>Ensure adequate source documentation is in place for all data reported
</li><li>Resolve data queries issued by the sponsor</li><li>Obtain protocol clarifications from the study sponsor and communicate information to the research team
</li><li>Facilitate the request and shipment of samples
</li><li>Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies</li><li>Assist in abstracts, presentations, and manuscripts</li></ul><br>
The following regulatory duties may be performed:
<br>
<br>
<ul><li>Assist with new study submission</li><li>Assist with updates and/or changes to current studies</li><li>Maintain and organize study specific regulatory binders</li><li>Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB</li><li>Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study</li><li>Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required</li><li>Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process</li><li>Collect, complete, and submit essential regulatory documents to various regulatory entities</li><li>Ensure appropriate documentation of delegation and training for all study staff members</li><li>Maintain screening and enrollment documentation</li><li>Prepare monthly enrollment and data summary for study team</li></ul><p></p><p><b><br>
Job Summary</b></p>
Summary<br>
Works independently under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. Will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting.<br>
<br>
Does this position require Patient Care?<br>
No<br>
<br>
Essential Functions<br>
<ul><li>Coordinate patient appointments with physicians, nurses, and all test areas.
</li></ul><br>
<ul><li>Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition.
</li></ul><br>
<ul><li>Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all criteria.
</li></ul><br>
<ul><li>Enroll patients as required by the study sponsor and internal enrollment monitor team.
</li></ul><br>
<ul><li>Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance.
</li></ul><br>
<ul><li>Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
</li></ul><br>
<ul><li>Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations.
</li></ul><br>
<ul><li>Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study.
</li></ul><br>
<ul><li>Collect, complete, and submit essential regulatory documents to various regulatory entities.</li></ul><p><br>
</p><div><div><div><div><div><div><div><p><b>Qualifications</b></p></div></div></div></div></div></div></div><div>
Education<br>
Bachelor's Degree Related Field of Study required<br>
<br>
Can this role accept experience in lieu of a degree?<br>
No<br>
<br>
Licenses and Credentials<br>
<br>
Experience<br>
Clinical Research or compliance experience 1-2 years preferred<br>
<br>
Knowledge, Skills and Abilities<br>
<ul><li>Ability to work independently and as a team member.</li><li>Analytical skills and ability to resolve problems.</li><li>Ability to interpret acceptability of data results.</li><li>Careful attention to detail.</li><li>Good organizational and communication skills.</li><li>Working knowledge of clinical research protocols.</li></ul></div><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>
Physical Requirements</b></p><ul><li>
Standing Frequently (34-66%)</li><li>
Walking Frequently (34-66%)</li><li>
Sitting Occasionally (3-33%)</li><li>
Lifting Frequently (34-66%) 35lbs+ (w/assisted device)</li><li>
Carrying Frequently (34-66%) 20lbs - 35lbs</li><li>
Pushing Occasionally (3-33%)</li><li>
Pulling Occasionally (3-33%)</li><li>
Climbing Rarely (Less than 2%)</li><li>
Balancing Frequently (34-66%)</li><li>
Stooping Occasionally (3-33%)</li><li>
Kneeling Occasionally (3-33%)</li><li>
Crouching Occasionally (3-33%)</li><li>
Crawling Rarely (Less than 2%)</li><li>
Reaching Frequently (34-66%)</li><li>
Gross Manipulation (Handling) Frequently (34-66%)</li><li>
Fine Manipulation (Fingering) Frequently (34-66%)</li><li>
Feeling Constantly (67-100%)</li><li>
Foot Use Rarely (Less than 2%)</li><li>
Vision - Far Constantly (67-100%)</li><li>
Vision - Near Constantly (67-100%)</li><li>
Talking Constantly (67-100%)</li><li>
Hearing Constantly (67-100%)</li></ul><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>

Clinical Research Associate/Clinical Research Coordinator I

Edwards Lifesciences

<div><p>Imagine how your ideas and expertise can change a patient&rsquo;s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients&rsquo; lives. As part of our Clinical Affairs team, you&rsquo;ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
</p><p></p><p>Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards&rsquo; groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It&rsquo;s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
</p><p></p><p><b>How you will make an impact:
</b></p><ul><li>Field monitoring of studies and data collection for clinical trials, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
</li><li>Providing oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts), and recommending and developing process improvements.
</li><li>Verifying trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
</li><li>Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
</li><li>Developing and delivering training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities.
</li><li>Contributing to the development of clinical protocols, informed consent forms, and case report forms.
</li><li>Editing/amending informed consent documents.
</li></ul><p></p><p><b>What you&rsquo;ll need (Required):
</b></p><ul><li>Bachelor's Degree or equivalent in related field with 3 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria.
</li>Ability to travel up to 75% domestically.<br>
<li>
<br>
</li></ul><p><b>What else we look for (Preferred):
</b></p><ul><li>Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification)
</li><li>Strong written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills
</li><li>Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
</li><li>Demonstrated problem-solving and critical thinking skills
</li><li>Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
</li><li>Substantial understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
</li><li>Technical writing skills (protocols, CRF development, study tools)
</li><li>Ability to communicate and relate well with key opinion leaders and clinical personnel
</li></ul><p></p><p>Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
<br>
<br>
For Massachusetts (MA), the base pay range for this position is $87,000 to $123,000 (highly experienced).
<br>
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The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
</p><p></p><p>E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
</p><p></p><p><b>COVID Vaccination Requirement
</b></p><p>Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.</p></div>

Clinical Research Monitoring Specialist

Boston Children's Hospital

<p></p><div><div><div><div>The department of Neurosurgery is looking for a new Clinical Research Assistant to join our team. Our research focuses on a myriad of neurosurgical research topics and we have active projects in all types of research. If you are selected for this competitive role, you can expect to be involved in case reports, retrospective chart reviews, device/drug trials, national and international level data and bio-specimen repositories, as well as investigator and sponsor initiated clinical trials. During your time here, you will be expected to participate in all aspects of the department research, and will not be tied to a specific project or PI. We do our best to align your individual interests within our department, but the department research needs will dictate the work that you are assigned to. You would work collaboratively alongside your research manager and other RAs to complete research tasks (from screening through project close out) across the department.<br>
<br>
<b>Key Responsibilities</b><ul><li>
Consents and recruits patients for research studies through personal interviews and written communications with patients/families. Provides detailed background information regarding studies to families, communicates all policies and procedures, and responds to all inquiries. Evaluates suitability of prospective study candidates and makes selections based upon clinical knowledge of each study.</li><li>
Serves as liaison to the families/patients in the research studies, conducted at both on site and off site locations, guiding and advising them throughout each phase of the study. Coordinates follow up visits as necessary. Acts as a resource to study participants, addressing any concerns they may have. Troubleshoots resolution of any issues that may arise throughout the study.</li><li>
Coordinates and prepares the necessary documentation for Institutional Review Board IRB and Committee on Clinical Investigations CCI submissions, together with the Private Investigator or Regulatory Manager of the study.</li><li>
Creates and prepares data collection statistical reports and analytical summaries for distribution to study research team for review and analysis. Writes articles and summary papers of studies for submission to medical journals, as may be necessary/requested.</li><li>
Participates in the training of newly hired research study assistants, as required.</li><li>
Coordinates activities between the hospital and research laboratories to ensure correct testing/processing and send out instructions specific to the study. Communicates project policies and procedures to personnel. Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study.</li><li>
Performs other miscellaneous administrative duties as assigned or required.</li></ul><b>
Minimum Qualifications</b><br>
<b>Education:</b><ul><li>
Bachelor's Degree in STEM or Psychology</li></ul><b>
Experience:</b><ul><li>
Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.</li><li>
Well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions.</li><li>
Advanced writing skills.</li></ul></div>
</div><div><p><b>Status</b></p>
<div>Full-Time</div>
</div><div><p><b>Regular, Temporary, Per Diem</b></p>
<div>Regular
</div></div><div><p><b>Standard Hours per Week</b></p>
<div>40
</div></div><div><p><b>Pay Range</b></p>
<div>$41246.40-$61339.20 Annual</div>
</div><div><p><b>Office/Site Location</b></p>
<div>Boston</div>
</div><div><p><b>Job Posting Category</b></p>
<div>Research</div>
</div><div><p><b>Remote Eligibility
</b></p><div>Part Remote/Hybrid</div></div></div></div><div></div>

Clinical Research Assistant- Neurosurgery Research

Adams Clinical

<div>
 <strong>
  Join Us in Shaping the Future of Clinical Research
  <br/>
  <br/>
 </strong>
 Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromising data quality, safety, and diverse enrollment to advance healthcare. Our vision is to set the gold standard for clinical trial excellence. We believe our people make the difference. Guided by our core values&mdash;Scientific Rigor, Operational Excellence, Commitment to Sponsors and Participants, and Authentic Collaboration&mdash;we create an environment where meaningful work drives meaningful change.
 <br/>
 <br/>
 At Adams Clinical, you&rsquo;ll find:
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 <ul>
  <li>
   A culture of respect, transparency, and continuous improvement
  </li>
  <li>
   Opportunities for professional growth and learning
  </li>
  <li>
   A team dedicated to improving lives through innovation and integrity
   <br/>
   <br/>
  </li>
 </ul>
 If you&rsquo;re passionate about making an impact in clinical research and want to be part of a collaborative, mission-driven organization, we&rsquo;d love to have you on our team.
 <br/>
 <br/>
 <strong>
  Overview
  <br/>
  <br/>
 </strong>
 Adams Clinical is a rapidly growing research site network specializing focused on late phase industry-sponsored trials of novel treatments for a variety of psychiatric and neurological conditions, supporting both inpatient and outpatient studies. Adams Clinical Site Network has locations in Watertown, MA; Boston, MA; Harlem, NY; Bronx, NY; Philadelphia, PA; and Dallas, TX.
 <br/>
 <br/>
 We are seeking entry-level applicants for the Clinical Research Assistant role at our Boston location (Zipcode: 02116). This role is ideal for entry-level candidates interested in learning clinical research operations, contributing to study execution, and developing foundational skills in patient interaction, data management, and regulatory compliance.
 <br/>
 <br/>
 The Clinical Research Assistant (RA) provides foundational support in the conduct of clinical trials at the site level. Working under the direct supervision of a CRC II, CRC III, or Site Manager, the RA assists with operational, administrative, and participant-facing tasks to ensure studies run smoothly and in accordance with ICH-GCP, regulatory requirements, and protocol guidelines. This role is an ideal entry point for individuals seeking to gain hands-on experience in clinical research.
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 <strong>
  Key Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Support study start-up activities, including supply inventory, document preparation, and site initiation readiness.
  </li>
  <li>
   Assist with participant screening workflows as delegated, including scheduling screening visits and collecting basic information such as demographics, medical history, and other study-relevant details to support eligibility assessment.
  </li>
  <li>
   Schedule and prepare for participant visits, including source prep, lab kits, and CRFs.
  </li>
  <li>
   Serve as a participant liaison&mdash;confirm appointments, coordinate transportation, and maintain ongoing communication.
  </li>
  <li>
   Escort and assist participants during on-site visits; perform vital signs, ECGs, and specimen collection/processing as trained.
  </li>
  <li>
   Complete accurate, ALCOA+-compliant source documentation for delegated procedures.
  </li>
  <li>
   Perform data entry into EDC systems and assist with query resolution.
  </li>
  <li>
   Maintain study binders, charts, and logs; support supply management.
  </li>
  <li>
   Ensure accurate capture and upload of paper source documents into eSource systems in accordance with site processes and regulatory requirements, supporting long-term retention and audit readiness.
  </li>
  <li>
   Obtain, track, and manage medical releases, as well as medical and pharmacy records from external providers as needed, in accordance with site SOPs and protocol requirements.
  </li>
  <li>
   Support CRCs during monitoring visits and assist with preparing documentation and materials to ensure audit and inspection readiness.
  </li>
  <li>
   Assist with investigational product (IP) accountability tasks as needed and where applicable, gaining exposure to IP handling, tracking, and documentation under the direct supervision of CRC staff, while ensuring adherence to protocol and site SOPs.
  </li>
  <li>
   Develop proficiency in site SOPs, institutional policies, and GCP requirements to build foundational knowledge in compliant research practices.
  </li>
  <li>
   Assist in collecting and entering study data into trackers, logs, and EDC systems, focusing on accurate and timely data collection.
  </li>
  <li>
   Support CRCs in maintaining accurate records and updating study metrics.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Minimum requirement of a high school diploma or GED equivalent; Bachelor&rsquo;s degree preferred.
  </li>
  <li>
   No prior clinical research experience is necessary; training will be provided. Basic understanding of clinical research principles is a plus.
  </li>
  <li>
   Strong attention to detail, organization, and communication skills.
  </li>
  <li>
   Proficiency in Microsoft Office.
  </li>
  <li>
   Willingness to perform phlebotomy and clinical procedures as trained.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Pay
 </strong>
 : $24.00 - $26.00 per hour
 <br/>
 <br/>
 <strong>
  Benefits
 </strong>
 :
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 <ul>
  <li>
   401(k) matching
  </li>
  <li>
   Medical, Dental &amp;Vision insurance
  </li>
  <li>
   Employee assistance program
  </li>
  <li>
   Flexible spending account
  </li>
  <li>
   Health insurance
  </li>
  <li>
   Health savings account
  </li>
  <li>
   Life insurance
  </li>
  <li>
   Paid time off
  </li>
  <li>
   Parental leave
  </li>
  <li>
   Professional development assistance
   <br/>
   <br/>
  </li>
 </ul>
 Adams Clinical is committed to being an equal opportunity and affirmative action employer. We focus on hiring and nurturing top talent. All employment decisions, including recruitment, hiring, promotion, compensation, transfer, training, discipline, and termination, are made based on the candidate's or employee's qualifications relevant to the position. These decisions are made without regard to age, sex, sexual orientation, gender identity or expression, genetic information, race, color, creed, religion, ethnicity, national origin, citizenship, disability, marital status, military status, pregnancy, or any other legally protected status.
 <br/>
 <br/>
 In compliance with federal law, all individuals hired must, as a condition of employment, provide documentation verifying their identity and authorization to work in the United States and complete Form I-9 within the required timeframe. Adams Clinical participates in E-Verify to confirm employment eligibility.
</div>


Clinical Research Assistant

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