clinical research 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

Nebraska Medicine

<div><div><div><div><div><div><div><div><div>Serious Medicine is what we do. Being extraordinary is who we are. Every colleague plays a key role in upholding this promise to our patients and their families.</div></div></div></div></div></div></div></div><div></div><div>
Shift:</div>
First Shift (United States of America)<div></div><div>
Manager Clinical Research</div><div></div><div>
This is one of those roles that truly sits at the intersection of research, finance, compliance, and leadership.</div><div>
The Manager of Clinical Research oversees our CRC start-up team &mdash; ensuring budgets, coverage analysis, and regulatory processes are executed with precision &mdash; while also serving as the business analyst for our Clinical Trials Management System.</div><div>
Because this is a promotion backfill, we know this role offers visibility and growth. We&rsquo;re looking for someone who thrives in complexity, enjoys building structure, and can lead a team while navigating grants, governmental regulations, and competing priorities.</div><div></div><div>
Details: Manager Clinical Research</div><ul><li>
Candidate must live in Nebraska or Iowa</li><li>
This is a hybrid position, must be able to work on campus</li><li>
Preferred consideration will be given to applicants with a master's degree in scientific, healthcare, or business-related field</li><li>
Resume REQUIRED for consideration</li></ul><div></div><div>
Why Work at Nebraska Medicine?</div><ul><li>
Together. Extraordinary. Join a team that values your skills, delivering exceptional care through collaboration.</li><li>
Leading Health Network Work with the region&rsquo;s top academic health network, partnering with UNMC to transform lives through education, research, and patient care.</li><li>
Dignity and Respect: We value all backgrounds and experiences, reflecting the communities we serve.</li><li>
Educational Support Enjoy up to $5,000/year in tuition assistance, a 35% discount at Clarkson College, and career advancement opportunities with covered educational costs.</li></ul><div>
Be part of something extraordinary at Nebraska Medicine!</div><div></div><div>
The Manager of Clinical Research is responsible for the CRC start-up team (coverage analysis, regulatory, budgets) and provide oversight of research studies using CRC resources. Assist in developing and implementing policies. Serve as the business analyst for the Clinical Trials Management System. Responsible for hiring and performance management of direct reports.<br>
<br>
Required Qualifications: Manager Clinical Research<br>
<br>
<ul><li>Three years' experience with budget model methodology in a healthcare setting required.</li><li>Working knowledge of research and medical terminology, grants, and governmental rules and regulations required.</li><li>Two years leadership experience required.</li><li>Bachelor's degree in scientific, healthcare or business-related field required.</li><li>Project management skills and ability to manage priorities and utilize time effectively required.</li><li>Competence in communication skills with demonstrated ability to communicate both written and verbal required.</li><li>Ability to market services to customer groups within and outside of UNMC required.</li></ul><br>
Preferred Qualifications: Manager Clinical Research<br>
<br>
<ul><li>Master's degree in scientific, healthcare, or business-related field preferred.</li></ul></div><div></div><div><div><div><div><div><div><div><div><br>
Nebraska Medicine is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, marital status, sex, age, national origin, disability, genetic information, sexual orientation, gender identity and protected veterans&rsquo; status.</div></div></div></div></div></div></div></div></div>

Manager Clinical Research

Cancer Specialists of North Florida

<div><p><b><i>Cancer Specialists of North Florida</i></b> is recruiting for an experienced <b><i>Research Business Program Manager</i></b> for our busy <b><i>Research Department.</i></b> The Research Business Program Manager will be responsible for executing key deliverables by utilizing innovative tactics, processes, tools, systems, and strategies to ensure research program efficiency, quality, and compliance is maintained. The Research Business Program Manager will work closely with the Clinical Research Director and Clinical Research Manager on process improvement and quality assurance, training of department staff, and adherence to clinical trial protocols. The Research Program Manager will also assist with research billing activities to ensure adherence to clinical trial budgets and contracts. Essential duties and responsibilities include the following:</p><p><b>
Operational Management &amp; Execution</b></p><ul><li>
Work closely with the Director of Clinical Research to standardize and optimize research operations across all trials, ensuring consistent execution, reduced variability, and scalable workflows as the portfolio grows.</li><li>
Proactively identify operational inefficiencies, performance gaps, and compliance risks; design, implement, and sustain process improvements that measurably improve startup timelines, enrollment throughput, and data quality.</li><li>
Develop, maintain, and continuously refine enterprise-level tracking systems that provide real-time visibility into:<ul><li>
Trial enrollment and accrual performance</li><li>
Physician participation and engagement trends</li><li>
Research staff workload, capacity, and utilization</li></ul></li><li>
Establish and enforce quality benchmarks and operational standards that align with GCP, sponsor expectations, and organizational performance goals.</li></ul><p><b>
Quality Assurance, Compliance &amp; Audit Readiness</b></p><ul><li>
Own the development and maintenance of QA-focused Standard Operating Procedures (SOPs), ensuring they are current, practical, and embedded into daily operations.</li><li>
Ensure all research activities are always inspection-ready, with clear documentation, traceability, and staff accountability.</li><li>
Serve as the operational lead for addressing audit and monitoring findings, maintaining continuous communication with leadership, staff, and external stakeholders until closure.</li></ul><p><b>
Financial &amp; Billing Alignment</b></p><ul><li>
Partner with the billing and finance teams to ensure accurate, timely, and compliant research billing, minimizing financial risk and revenue leakage.</li><li>
Oversee research operational processes related to administrative and patient milestone tracking</li><li>
Identify and escalate billing or cost-related risks early, ensuring alignment between study budgets, services rendered, and revenue capture.</li><li>
Support leadership with transparent, auditable documentation related to research billing and cost accountability.</li></ul><p><b>
Team Leadership &amp; Staff Enablement</b></p><ul><li>
Serve as the primary operational authority for research staff regarding trial documentation standards, data integrity expectations, and system use.</li><li>
Ensure timely and accurate data entry, query resolution, and monitoring readiness across all studies.</li><li>
Establish clear expectations, tools, and accountability structures that enable staff to meet performance and quality benchmarks.</li><li>
Support onboarding, training, and ongoing competency development for data and QA-focused team members, ensuring consistent execution regardless of study complexity.</li><li>
Act as a stabilizing operational presence, reducing rework, confusion, and staff burnout through clarity and structure.</li></ul><p><b>
Study Start-Up, Systems &amp; Documentation</b></p><ul><li>
Own the development and maintenance of EMR-integrated research workflows, ensuring study-specific order sets, care plans, and documentation are accurate, standardized, and provider-friendly.</li><li>
Ensure consistency and integrity of source documentation standards across trials, providers, and staff.</li><li>
Support study start-up activities by validating operational readiness, documentation completeness, and system integration prior to activation.</li><li>
Partner in clinical trial budget review to identify operational or documentation risks that could impact billing, compliance, or execution.</li></ul><p>
Full-time Position, Monday &ndash; Friday</p><p><b>
Location:</b> 7751 Belfort Parkway, Jacksonville, FL 32256</p><p><b>
Education and Experience:</b></p><ul><li>
Bachelor&rsquo;s degree and 4+ years of experience in working with complex clinical trials from a site, sponsor, or CRO perspective with a preferred focus on oncology and/or hematology</li><li>
2+ years project and/or vendor management experience</li><li>
Data Quality Assurance (QA)/auditing experience is a plus</li></ul><p><b>
Certificates, Licenses, Registrations:</b></p><ul><li>
CCRP, preferred</li></ul><p><b>
Compensation and Benefits:</b></p><ul><li>
Salary is commensurate with experience and qualifications</li></ul><p>
Cancer Specialists of North Florida is an &quot;EEO Employer&rdquo; and &ldquo;Drug Free Workplace&rdquo;</p></div><p></p>

Research Business Program Manager

Iterative Health

<div><div><p>Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.</p></div><div><p><b>
About Iterative Health</b></p><br>
<p>
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.</p><p><br>
<b>
About the Role</b></p>
<p>
As the Senior Clinical Research Specialist II, you will work to integrate Iterative Health (IH) services and technology solutions at GI based, clinical research sites throughout the US. This external-facing role will require strong communication, customer engagement and deep expertise in clinical research, in addition to a strong strategic skill set. You&rsquo;ll work directly with a portfolio of sites to ensure they achieve their research goals.</p>
<p><b>
Responsibilities:</b></p>
<ul>
<li>Act as an SME on the clinical research services team in implementing best practices for specific areas of clinical research through training and mentorship</li>
<li>Demonstrate advanced knowledge of clinical research processes and tools, such as CTMS, pre-screening, and/or feasibility, and enhance these processes and outputs to effectively support our sites or internal teams</li>
<li>Serve as a subject matter expert on clinical research workflows, in line with specific requirements of each protocol</li>
<li>Manage customer relationships with a high degree of professionalism and expertise ensuring timely responses, escalations of site issues, and building trust needed to help sites achieve their research goals. Manage relationships with site managers, staff, and PIs at priority sites with high volume and high complexity</li>
<li>Leverage IH services and solutions to help build best practice research sites and accelerate clinical trials</li>
<li>Deliver customized training for different clinical research user groups and devise process maps/workflows, tools, and techniques to help sites incorporate IH services</li>
<li>Devise process maps/workflows, tools, and techniques to help sites incorporate IH services and AI solutions</li>
<li>Travel to customer sites to support study site activation, drive patient screening, and standby support for randomization activities</li>
<li>Collect, analyze, and communicate the voice of IH customer successes, concerns, and product adoption issues/competency gaps and collaborate with IH cross-functional teams to design and deliver solutions</li>
<li>Identify improvements needed to reach team goals and KPIs. Lead relevant projects/approaches with manager alignment</li>
</ul>
<p><b>What We&rsquo;re Looking For</b></p>
<p>
Required Qualifications</p>
<ul>
<li>Minimum 5 years of clinical research coordinator</li>
<li>Experience with phase 2-4 pharma-sponsored clinical trials, including study start-up, CDA, feasibility, regulatory/standard operating procedures, study protocols, and regulations governing clinical research</li>
</ul><ul><li>Experience coordinating, evaluating, and following patients&rsquo; participation through clinical trials</li>
<li>Fluent in the use of Microsoft Office/Google Apps products</li>
<li>Ability to navigate ambiguity and willingness to be flexible/adapt to changing work environments</li>
<li>Desire to work with new tools and technology</li>
<li>Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately</li>
<li>Willingness to travel to customer sites (~30%)</li>
<li>BS/BA or higher degree</li>
</ul>
<p>Preferred Qualifications</p>
<ul>
<li>5+ years as a Clinical Research Coordinator (CRC) working with GI (IBD) and/or Hep (MASH) trials</li>
<li>8+ years of experience with phase 2-4 pharma-sponsored clinical trials</li>
<li>General understanding of the evaluation and diagnosis of Inflammatory Bowel Disease (IBD) and/or Metabolic dysfunction-associated steatohepatitis (MASH)</li>
<li>Experience with CTMS systems - preferably RealTime or CRIO</li></ul><br>
<p></p>
<p><b>
What We Offer</b></p>
<ul>
<li>Medical, dental, and vision insurance</li>
<li>Life and disability insurance</li>
<li>Parental leave</li>
<li>Stock options</li>
<li>Flexible work hours</li>
<li>Unlimited paid time off</li><br>
</ul>
<p><b>Our Commitment to Diversity</b><br>
At Iterative Health, we&rsquo;re building a team that reflects the diversity of the patients we serve. We are committed to fostering an inclusive and equitable workplace, including our hiring process. If you require accommodations during the application or interview process, please reach out to: CandidateAccommodations@iterative.health.</p></div><div><div><p>
New York pay range</p><p>
$100,000 - $110,000 USD</p></div></div><div><p>
At Iterative Health, we&rsquo;re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.</p></div></div>

Sr. Clinical Research Specialist II

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><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

ICON plc

<div>Centralized Clinical Trial Manager<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Centralized Clinical Trial Manager to join our diverse and dynamic team. As a Centralized Clinical Trial Manager at ICON, you will play a crucial role in overseeing the centralized monitoring activities of clinical trials, ensuring the smooth coordination of data-driven insights to enhance trial quality and patient safety. You will contribute to the advancement of innovative treatments and therapies by managing centralized trial activities and collaborating with cross-functional teams to ensure study compliance and efficiency.</div><div></div><div>
Location: Bangalore or Chennai ( Home Based or Office Based)</div><div></div><div>
What You Will Be Doing:</div><div></div><ul><li>
Leading the centralized monitoring activities for clinical trials, including data review and risk-based monitoring.</li><li>
Collaborating with Clinical Operations, Clinical Trial Management and Project Management teams to identify potential monitoring risks and ensuring proactive escalation of monitoring issues.</li><li>
Ensuring study compliance with regulatory requirements and protocols by overseeing real-time data reviews and monitoring activities.</li><li>
Providing oversight on site performance, patient safety, and data quality through focused monitoring data insights and analytics.</li><li>
Coordinating with cross-functional teams to ensure efficient execution of clinical trials and contribute to continuous improvement in trial processes.</li></ul><div></div><div>
Your Profile:</div><ul><li>
Bachelor&rsquo;s degree in life sciences, healthcare, or a related field (advanced degree preferred).</li><li>
Minimum 8-10 years of Clinical Research experience with at-least 5 years of on-site monitoring experience.</li><li>
Experience in On-Site Monitoring and Clinical Trial Management, with a solid understanding of on-site monitoring approaches.</li><li>
Strong analytical skills with proficiency in clinical trial data review and interpretation.</li><li>
Excellent organizational and project management skills, with the ability to manage multiple studies and meet deadlines.</li><li>
Effective communication and interpersonal skills, with the ability to collaborate across diverse teams and functions.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Centralized Clinical Trial Manager

Fortrea

<div><p><i>Come join Fortrea in a newly created HR Manager role embedded within our Dallas, TX or Madison, WI Clinical Research Units. This is a critical opportunity to partner closely with the teams delivering life‑changing research and to strengthen how we support, develop, and retain our people. Sitting directly with the business, this role brings a deep understanding of trial delivery realities, workload pressures, and regulatory demands&mdash;enabling closer alignment, faster support, and more impactful people solutions.</i></p><p></p><p><b>
Job Overview:</b></p><p>
The Manager, HR &ndash; Clinical Research Units (CRUs) is a multisite HR partnership role responsible for engagement strategies, employee relations, and talent strategy across CPS Clinical Research Units. Reporting to Executive Director, Global HR Business Partnering, this role partners closely with the site leadership including Clinic Senior Directors, Global HR COEs, and Clinic Senior Directors to align clinic workforce strategies with CPS business objectives. This is a highly operational, clinic-embedded role requiring strong presence, sound judgment, and the ability to lead through complexity in regulated clinical environments.</p><p></p><p><b>
Key Responsibilities:</b></p><ul><li><p>
Lead employee engagement and talent strategies for CPS Clinical Research Units in alignment with CPS global strategy.</p></li><li><p>
Serve as the primary HR leader for clinic-based employees, partnering closely with Clinic Senior Directors and site leadership.</p></li><li><p>
Manage employee relations matters including investigations, corrective actions, terminations, and reductions in force.</p></li><li><p>
Partner with HR Centers of Excellence on incentive programs, compensation, workforce planning, and staffing strategies.</p></li><li><p>
Support harmonization of HR practices and employee experience across all CPS clinics globally.</p></li><li><p>
Provide CPS HR oversight for the UK clinic in partnership with the UK Regional HR Partner.</p></li><li><p>
Act as primary HR partner to clinic physicians and pharmacy leadership.</p></li><li><p>
Operate effectively within a matrixed HR structure with a dotted line to the Regional Head of HR, Americas.</p></li><li><p><b>
Maintain an onsite presence at the Dallas, TX or Madison, WI CRU and travel quarterly to other clinics.</b></p></li><li><p>
Ensure safe and responsible use of vehicles for business purposes and report driving-related incidents as required.</p></li><li><p>
Perform all other duties as needed or assigned.</p></li></ul><p></p><p><b>
Qualifications (Minimum Required)</b></p><ul><li><p>
Bachelor&rsquo;s degree required. Fortrea may consider equivalent experience in lieu of degree requirements.</p></li><li><p>
Strong expertise in employee relations and HR partnering within regulated or operational environments.</p></li><li><p>
Excellent communication, conflict resolution, and stakeholder management skills.</p></li><li><p>
Ability to operate effectively in a matrixed, global organization.</p></li><li><p>
Valid driver&rsquo;s license with a clean driving record.</p></li></ul><p></p><p><b>
Experience (Minimum Required)</b></p><ul><li><p>
5+ years of progressive HR experience, including ER.</p></li><li><p>
Experience supporting multisite or operationally complex organizations.</p></li><li><p>
Demonstrated experience managing employee relations matters.</p></li><li><p>
Highly prefer clinical environment experience</p></li></ul><p></p><p>
Pay Range: $100,000-$120,000 (The range does not include benefits, and if applicable, bonus, commission, or equity)</p><p><br>
Benefits: All job offers will be based on a candidate&rsquo;s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable. For more detailed information, please click here.</p><p></p><p><b>
Physical Demands / Work Environment</b></p><p>
Work is performed in a clinical and office environment with regular onsite presence at clinic locations. Role requires frequent travel, extended periods of standing or sitting, and the ability to use standard office and clinical equipment.</p><p></p><p>
#LI-LL1</p><p></p><p>
Learn more about our EEO &amp; Accommodations request here.</p></div>

HR Manager, Clinical Research Unit - Dallas, TX or Madison, WI (On-Site)

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