clinical trial manager

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Discovery &amp; Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development &amp; Research &ndash; Non-MD
Job Category:
People Leader
All Job Posting Locations:
Irvine, California, United States of America
Job Description:
.
Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that&rsquo;s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for a Clinical Research Manager to support our Electrophysiology business. This role will work a Flex/Hybrid schedule with 2-3 days per week onsite in our Irvine, CA office. Remote candidates may also be considered.
Responsibilities:
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson &amp; Johnson, procedures and guidelines, this position:<ul><li>
Serves as a Clinical Research Manager within the Clinical R&amp;D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones</li><li>
Has oversight of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
</li><li>Manages and oversees ordering, tracking, and accountability of investigational products and trial materials;</li><li>
Ensures applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;</li><li>
Is responsible for team&rsquo;s interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel;
</li><li>Is responsible for clinical data review to prepare data for statistical analyses and publications;</li><li>
May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;</li><li>
In EMEA, responsible for Regulatory Affairs related tasks associated with clinical trials and evidence generation. (See ANNEX I &ndash; Regulatory Affairs Duties and Responsibilities);
</li><li>Contribute to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management, with collaborative relationships with all relevant Clinical R&amp;D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&amp;D, etc), ensuring cross-functional alignment;</li><li>
Ensures input and strong alignment from key regional Clinical R&amp;D leads and other strategically important countries/ regions in the development of the EGS/ EDS;</li><li>
Leads in study design to develop appropriate clinical trials to meet the clinical evidence needs;</li><li>
May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;</li><li>
Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.;</li><li>
Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);</li><li>
Plans, tracks and manages assigned project budgets to ensure adherence to business plans;
</li><li>Contributes in clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;</li><li>
Serves as the clinical representative on a New Product Development team;</li><li>
Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;</li><li>
Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;</li><li>
Is responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition;</li><li>
Manages and mentors resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency;</li><li>
Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;</li><li>
Is responsible for communicating business related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;</li><li>
Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;</li><li>
Should develop a strong understanding of the pipeline, product portfolio and business needs;</li><li>
Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed.</li><li>
May perform other duties assigned as needed;</li></ul>
Education<ul><li>
Minimum of a Bachelor&rsquo;s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.</li></ul>
Experience<ul><li>
A minimum of 8 years related scientific/ technical experience, including leadership/ management role within Clinical Research.</li><li>
Significant previous experience in clinical project leadership across multiple studies/ programs is required.</li><li>
Experience working well with cross-functional teams is required.</li><li>
Experience with budget planning, tracking and control is required.</li><li>
Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, &hellip;).</li><li>
Clinical/medical background is a plus.</li><li>
A minimum of 1-2 year people management related experience is a plus.</li><li>
Medical device experience is highly preferred.</li></ul>
Functional and Technical Competencies:<ul><li>
Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;</li><li>
Ability to provide scientifically strategic and scientific clinical research input across New Product Development and Life-Cycle Management projects, including complex and/ or transformational projects; Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;</li><li>
Strong presentation and technical writing skills;</li><li>
Strong written and oral English communication skills;</li><li>
Comprehensive understanding of clinical trial regulations across multiple regions;</li><li>
Demonstrates competencies in the following area are required:<ul><li>
Ability to lead teams to deliver critical milestones, including complex projects</li><li>
Strong project management skills with ability to handle multiple projects</li><li>
Strong people management skills</li><li>
Change agent in team development and progression</li></ul></li></ul>
Leadership Competencies:
Strong leadership required in alignment with J&amp;J Leadership Imperatives:<ul><li>
Connect &ndash; Develop strong collaborative relationships with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/ EDS. Create strong and productive partnership with resource providers and vendors.</li><li>
Shape - Make recommendations for and actively participate and lead in departmental process improvement activities. Through efficient use of resources, shape the way clinical trial management is conducted and resources are utilized.</li><li>
Lead - Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues.</li><li>
Deliver - Ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned.</li></ul>
Primary location for this position is Irvine, CA. At management discretion, the position may be performed remotely.
Ability to travel approximately 20-25% depending on the phase of the program.
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Clinical Data Management, Clinical Evaluations, Consulting, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Team Management
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 
 
Vacation &ndash;120 hours per calendar year 
 
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado &ndash;48 hours per calendar year; for employees who reside in the State of Washington &ndash;56 hours per calendar year 
 
Holiday pay, including Floating Holidays &ndash;13 days per calendar year 
 
Work, Personal and Family Time - up to 40 hours per calendar year 
 
Parental Leave &ndash; 480 hours within one year of the birth/adoption/foster care of a child 
 
Bereavement Leave &ndash; 240 hours for an immediate family member: 40 hours for an extended family member per calendar year 
 
Caregiver Leave &ndash; 80 hours in a 52-week rolling period10 days 
 
Volunteer Leave &ndash; 32 hours per calendar year 
 
Military Spouse Time-Off &ndash; 80 hours per calendar year 
 
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid</div>

Clinical Research Manager

Dana-Farber Cancer Institute

<div><div><div><div>Job Ref:</div><div>
JR-3898</div></div> 
<div><div>Location:</div><div>
450 Brookline Ave, BOSTON, MA 02215</div> 
</div>
<div><div>Category:</div><div>
Clinical Research</div></div> 
<div><div>Employment Type:</div><div>
Full time</div></div> 
<div><div>Work Location:</div><div>
Remote: 100% off site</div></div> 
<div></div><div><div>Salary/Pay Rate:</div><div>
$70,000.00 - $85,300.00 per year</div>
</div></div>Overview
<div><div>This Assistant Clinical Research Manager (ACRM) position will work within the Breast Oncology clinical research program and assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. These positions, in collaboration with the program&rsquo;s Clinical research Managers physicians and research nursing staff, are responsible for assisting with the design, implementation and evaluation of their program&rsquo;s clinical research activities, related regulatory oversight, and will provide day to day supervision of their program&rsquo;s clinical research staff as needed.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. 
Clinical Trials Operations
<ul><li>Assistant Clinical Research Managers (ACRM) will be responsible for assisting the Clinical Research Manager with the oversight of their disease group&rsquo;s clinical trial portfolio and all related regulatory and compliance requirements.</li><li>
The ACRM will assist the CRM will all aspects of study start up, active and close out activities for the group&rsquo;s portfolio. They will be responsible for the required tracking of all protocol development, submission, review and approval milestones.</li><li>
The ACRM will assist with the oversight of subject enrollment, protocol treatment and follow-up care processes for protocol patients.</li><li>
Assist with the oversight of registration of protocol patients, study group registrar and pharmaceutical company as outlined in protocol.</li></ul>
Regulatory &amp; Compliance
<ul><li>Assists in the responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.</li><li>
Assists in the responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. May implement systems to monitor portfolio compliance.</li><li>
Assists the study team to be maintain an &ldquo;audit ready&rdquo; research environment
</li></ul>Data Management &amp; Clinical Trial Monitoring
<ul><li>Assists CRM with responsibility for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.</li><li>
Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Helps to implement corrective action to maintain data compliance when necessary.</li><li>
Submits required &ldquo;progress / tracking &ldquo;reports to key stakeholders, when applicable.</li></ul>
Staff Training &amp; Development<ul><li>
Will assist the CRM with the recruitment and oversight of coordinator staff as well as ensures that staff have completed mandatory training in a timely manner.</li><li>
Will help implement program specific on-boarding and orientation process and may participate in annual performance evaluations and competency assessments of research staff as needed.</li></ul>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
<ul><li>Must be able to perform day-to-day responsibilities independently with minimal supervision from managers.</li><li>
Has the ability to identify regulatory scenarios that require consultation.</li><li>
Has a good understanding of clinical trials start-up, active and close out phases.</li><li>
Has a good understanding of clinical research, local policy and federal regulation.</li><li>
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.</li><li>
In addition, has experience in protocol development, data compilation and analysis.</li><li>
The ACRM will have a good understanding of the various tracking systems used to ensure timely data management by the clinical research staff.</li><li>
They will also understand Federal and State regulations as they relate to research. Strong interpersonal, organizational and communication skills are required.</li><li>
Must have computer skills including the use of Microsoft Office.</li></ul>
MINIMUM JOB QUALIFICATIONS:
<ul><li>Bachelor&rsquo;s Degree required.</li><li>
Minimum of 3 plus years of related experience preferred.</li><li>
Must have the ability to function independently, think critically and with good professional judgment.</li></ul>
License/Certification/Registration: N/A
SUPERVISORY RESPONSIBILITIES: No direct report<ul><li>
Will provide day to day supervision for study management staff, including clinical research coordinators, students, volunteers, and other research assistants as needed.</li></ul>
PATIENT CONTACT: May have contact with patients of all ages and populations.
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to .
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
<h3 class="jobSectionHeader">EEO Poster</h3>
.
Pay Transparency Statement
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate&rsquo;s relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).
$70,000.00 - $85,300.00</div></div></div>

Assistant Clinical Research Manager - Breast Oncology Clinical Trials

Columbia University

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule: M-F; 9AM-5PM</li>
<li>Building:</li>
<li>Salary Range: $100,000.00 - $135,000.00</li>
</ul><div>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div> 
<div></div>

Position Summary

This position will support the development and growth of a department‑wide Dermatology Clinical Trials Unit under the direction of the Vice Chair for Clinical Research.

The Clinical Research Program Manager will oversee operational infrastructure for clinical and translational research across multiple faculty investigators. The individual will help build a scalable clinical research program that integrates clinical trials, translational research, and collaborative initiatives across Columbia University Irving Medical Center.

This role combines strategic program management with operational leadership and hands‑on clinical research expertise. The successful candidate will help develop workflows, supervise research staff, coordinate regulatory and operational activities, and ensure efficient study activation and execution. This position also requires the ability to step into Clinical Research Coordinator responsibilities, when necessary, particularly during early program growth, study startup, or smaller investigator‑initiated studies.

Position Goals
<ul>
<li>Build and support department-wide Dermatology Clinical Trials Unit</li>
<li>Expand clinical and translational research across department</li>
<li>Support multiple investigators</li>
<li>Improve study activation timelines</li>
<li>Increase patient access to clinical trials</li>
<li>Strengthen collaboration across Columbia research network</li>
</ul>
Reporting Structure

The Clinical Research Program Manager will report to the Vice Chair for Clinical Research within the Department of Dermatology and work closely with Department Chair, faculty investigators, and institutional research leadership.

Responsibilities

Clinical Research Program Development

The Clinical Research Program Manager will work closely with the Vice Chair for Clinical Research to build a department‑wide research infrastructure that supports multiple investigators and study types. This includes developing standardized workflows, supporting new trial development, coordinating operational infrastructure, and helping expand clinical and translational research across dermatology. The individual will help create processes for study prioritization, resource allocation, and staff deployment across investigators, ensuring efficient and scalable program growth. 
The Clinical Research Program Manager will conduct clinical trial operations, including but not limited to:
<ul>
<li>Oversee study startup, activation, and execution across multiple investigators</li>
<li>Coordinate feasibility assessments for new studies</li>
<li> Ensure regulatory and operational compliance</li>
<li> Monitor study timelines and enrollment targets</li>
<li> Support study closure and reporting</li>
<li> Direct clinical research activities (as needed)</li>
<li> Perform CRC duties when necessary</li>
<li> Assist with patient screening and enrollment</li>
<li> Support consenting and study visits</li>
<li> Assist with data collection and documentation</li>
<li> Support early-phase and underfunded studies</li>
</ul>
Translational Research and Biobanking

The role will include coordination of translational research activities including biospecimen collection, tissue‑based research, biomarker studies, and biobanking. The Program Manager will work with investigators and laboratory collaborators to ensure proper specimen handling, regulatory compliance, and integration of translational research components into clinical trials. This individual will help develop infrastructure supporting translational studies and ensure alignment between clinical and laboratory‑based research.
<ul>
<li>Coordinate translational research components of clinical trials</li>
<li>Oversee biospecimen collection and biobanking activities</li>
<li>Support biomarker-driven and tissue-based studies</li>
<li>Coordinate with laboratory and translational research collaborators</li>
<li>Ensure regulatory compliance for biospecimen collection and storage</li>
</ul>
Institutional Collaboration

The Clinical Research Program Manager will work closely with institutional partners including the Clinical Trials Office (CTO), Sponsored Projects Administration (SPA), Institutional Review Board (IRB), various cancer center programs, and other stakeholders. The individual will facilitate communication and coordination between dermatology investigators and institutional resources to improve study activation timelines and support program growth.

Team Leadership and Staff Management

The Program Manager will supervise clinical research coordinators and support staff, assist with hiring and onboarding, and provide training and mentorship. The individual will help develop scalable and overlapping staffing models, and coordinate research personnel across multiple investigators and studies. Specifically:
<ul>
<li>Supervise clinical research coordinators and research staff</li>
<li>Assist in hiring and onboarding research staff</li>
<li>Train and mentor clinical research coordinators</li>
<li>Develop scalable staffing structure</li>
<li>Coordinate staff across multiple investigators</li>
<li>Provide operational support to multiple faculty investigators</li>
<li>Support investigator-initiated trials</li>
<li>Assist with early-phase and translational studies</li>
<li>Facilitate collaboration across investigators</li>
<li>Support development of new clinical trials</li>
</ul>
Financial and Operational Oversight
<ul>
<li>Assist with clinical trial budgeting</li>
<li>Track financial performance of research portfolio</li>
<li>Monitor study revenue and operational costs</li>
<li>Support financial sustainability of program</li>
</ul>
Quality and Compliance
<ul>
<li>Develop and maintain SOPs</li>
<li>Ensure regulatory compliance</li>
<li>Prepare for audits and monitoring visits</li>
<li>Implement quality improvement initiatives</li>
</ul>
Minimum Qualifications
<ul>
<li>Bachelor&rsquo;s degree in life sciences, health sciences, or related field</li>
<li>Minimum 5 years clinical research experience</li>
<li>Experience managing multiple clinical trials</li>
<li>Experience with regulatory submissions and IRB processes</li>
<li>Knowledge of Good Clinical Practice (GCP)</li>
</ul>
Preferred Qualifications
<ul>
<li>Master&rsquo;s degree preferred</li>
<li>Experience in academic medical center</li>
<li>Experience supervising research staff</li>
<li>Experience with translational research and biospecimen collection</li>
<li>Experience with investigator-initiated trials</li>
<li>Experience with industry-sponsored trials</li>
</ul>
Other Requirements

The ideal candidate will be highly organized, collaborative, and capable of working in a complex academic medical center environment. The individual must be comfortable managing multiple priorities, working with diverse investigators, and building operational infrastructure from the ground up. Strong communication skills, leadership ability, and experience navigating institutional processes are essential. The candidate should demonstrate initiative, flexibility, and the ability to transition between strategic planning and hands‑on operational work. The role requires a proactive individual who can anticipate challenges, develop solutions, and support the growth of a department‑wide clinical research program.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.</div>

Summit Therapeutics, Inc.

<div>
 
 About Summit
 
 
 
 Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit&rsquo;s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
 
 
 Summit&rsquo;s Team Is Inspired To Touch And Help Change Lives Through Summit&rsquo;s Clinical Studies In The Field Of Oncology. Summit Has Multiple Global Phase 3 Clinical Studies, Including
 
 
 
 Non-small Cell Lung Cancer (NSCLC)
 
 
 
 <ul>
 <li>
 HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
 </li>
 <li>
 HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
 </li>
 <li>
 HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
 
 
 </li>
 </ul>
 
 Colorectal Cancer (CRC)
 
 
 
 <ul>
 <li>
 HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
 
 
 </li>
 </ul>
 
 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China&rsquo;s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
 
 
 
 
 Overview Of Role
 
 
 
 The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial.
 
 
 
 Role And Responsibilities
 
 
 
 <ul>
 <li>
 Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
 </li>
 <li>
 Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
 </li>
 <li>
 Initiates and builds solid professional relationships with clinical site staff
 </li>
 <li>
 Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data
 </li>
 <li>
 Creation and development of study trackers
 </li>
 <li>
 Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
 </li>
 <li>
 Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc.
 </li>
 <li>
 Responsible for reviewing assigned study related plans, processes, agreements, and guidelines
 </li>
 <li>
 Following and implementing assigned study related plans, processes, agreements, and guidelines
 </li>
 <li>
 Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met
 </li>
 <li>
 Reviews and approves essential document packages to enable timely site activations.
 </li>
 <li>
 Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
 </li>
 <li>
 Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed
 </li>
 <li>
 Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
 </li>
 <li>
 Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF
 </li>
 <li>
 Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
 </li>
 <li>
 Ensures the study is &ldquo;inspection ready&rdquo; contemporaneously
 </li>
 <li>
 Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate
 </li>
 <li>
 All other duties as assigned
 
 
 </li>
 </ul>
 
 Experience, Education And Specialized Knowledge And Skills
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
 </li>
 <li>
 A minimum of 3+ years of clinical research experience in conducting clinical trials
 </li>
 <li>
 Prior phase II or III experience required
 </li>
 <li>
 A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
 </li>
 <li>
 Experience with clinical studies oncology and / or rare diseases a plus
 </li>
 <li>
 Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams
 </li>
 <li>
 Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
 </li>
 <li>
 Tenacity to work in a fast-paced team environment
 </li>
 <li>
 Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships
 </li>
 <li>
 Ability to successfully engage and work collaboratively with global team members/colleagues
 </li>
 <li>
 Ability to support building and delivery of patient enrolment strategies
 </li>
 <li>
 Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives.
 </li>
 <li>
 Ability to review and assess clinical data
 </li>
 <li>
 Possesses excellent planning, time management &amp; coordination skills.
 </li>
 <li>
 Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
 </li>
 <li>
 Experience in working in a small organization a plus
 </li>
 <li>
 Excellent written and oral communication skills
 
 
 </li>
 </ul>
 This is the pay for this position
 
 
 Pay Transparency
 
 
 $115,000 - $125,000 USD
 
 
 Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
 
 
 Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit&rsquo;s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
 
 
 Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
</div>

Clinical Research Associate

Solace Clinical Research

Job Summary We are seeking a dynamic and highly organized Clinical Research Site Manager to lead and oversee the daily operations of our clinical trial site. In this pivotal role, you will coordinate all aspects of clinical trials, ensuring compliance with regulatory standards, maintaining high-quality documentation, and fostering a patient-centered environment. Your leadership will drive the successful execution of research studies, facilitate effective communication among team members, and uphold the integrity of data collection and management. This position offers an exciting opportunity to contribute to groundbreaking medical research while supporting the advancement of healthcare solutions.Responsibilities<ul><li>Supervise and coordinate the activities of clinical research staff, including nurses, coordinators, and laboratory personnel, ensuring seamless trial operations</li><li>Manage patient recruitment, screening, enrollment, and ongoing monitoring to ensure adherence to study protocols and regulatory requirements</li><li>Oversee data collection processes, review source documents for accuracy, and ensure proper documentation in accordance with ICH GCP standards and FDA regulations</li><li>Maintain compliance with HIPAA regulations and ensure confidentiality of patient information throughout all trial activities</li><li>Review clinical documentation such as case report forms (CRFs), laboratory results, vital signs, and adverse event reports for completeness and accuracy</li><li>Monitor clinical laboratory procedures including blood sampling, phlebotomy, and specimen handling to ensure quality standards are met</li><li>Utilize electronic medical record (EMR) systems and statistical software for data management, analysis, and reporting purposes</li><li>Ensure adherence to CDISC standards for data formatting and reporting in clinical trials</li><li>Conduct regular site audits to verify compliance with protocol requirements and regulatory guidelines</li><li>Facilitate training sessions on Good Clinical Practice (GCP), FDA regulations, and study-specific procedures for staff members</li></ul>Qualifications<ul><li>Proven supervising experience in a clinical research environment or healthcare setting</li><li>Strong knowledge of clinical trials management, including patient monitoring and data collection techniques</li><li>Familiarity with medical terminology, clinical laboratory procedures, and blood sampling techniques</li><li>Experience with EMR systems, statistical software, and data management tools used in clinical research</li><li>In-depth understanding of FDA regulations, ICH GCP guidelines, HIPAA compliance, and CDISC standards</li><li>Certification in Good Clinical Practice (GCP) from a recognized issuer for CA or equivalent is required; additional certifications such as an ICH GCP certificate are preferred</li><li>Background in nursing or clinical laboratory work is advantageous</li><li>Excellent analysis skills with attention to detail for reviewing documentation and ensuring protocol adherence</li><li>Ability to lead teams effectively while maintaining a positive work environment</li></ul>Join us in advancing innovative healthcare solutions by managing impactful clinical research studies. Your expertise will help shape the future of medicine while supporting a collaborative team dedicated to excellence in clinical development.Pay: $20.00 - $38.00 per hourBenefits:<ul><li>401(k)</li><li>Health insurance</li><li>Paid time off</li></ul>Work Location: In person

Clinical Research Site Manager

Medpace

<div>
 
 Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team!
 
 
 
 This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace. Through our
 
 PACE&reg;
 
 Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.
 
 
 
 WE OFFER THE FOLLOWING
 
 
 
 <ul>
 <li>
 Competitive travel bonus;
 </li>
 <li>
 Equity/Stock Option program;
 </li>
 <li>
 Training completion and retention bonus
 </li>
 <li>
 Annual merit increases;
 </li>
 <li>
 401K matching;
 </li>
 <li>
 The opportunity to work from home;
 </li>
 <li>
 Flexible work hours across days within a week;
 </li>
 <li>
 Retain airline reward miles and hotel reward points;
 </li>
 <li>
 Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
 </li>
 <li>
 In-house travel agents, reimbursement for airline club, and TSA pre-check;
 </li>
 <li>
 Opportunity for leadership positions &ndash; Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
 </li>
 <li>
 CRA training program (PACE&reg;);
 </li>
 <li>
 Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
 </li>
 <li>
 In-house administrative support for all levels of CRAs; and
 </li>
 <li>
 Opportunities to work with international team of CRAs.
 
 
 </li>
 </ul>
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
 </li>
 <li>
 Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
 </li>
 <li>
 Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
 </li>
 <li>
 Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
 </li>
 <li>
 On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
 </li>
 <li>
 Verification that the investigator is enrolling only eligible subjects;
 </li>
 <li>
 Regulatory document review;
 </li>
 <li>
 Medical device and/or investigational product/drug accountability and inventory;
 </li>
 <li>
 Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
 </li>
 <li>
 Assess the clinical research site&rsquo;s patient recruitment and retention success and offering suggestions for improvement; and
 </li>
 <li>
 Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Must have a minimum of a Bachelor&rsquo;s degree in a health or science related field;
 </li>
 <li>
 Experience as a Clinical Research Coordinator (minimum 1 year);
 </li>
 <li>
 Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely
 </li>
 <li>
 Must maintain a valid driver&rsquo;s license and the ability to drive to monitoring sites;
 </li>
 <li>
 Proficient knowledge of Microsoft&reg; Office;
 </li>
 <li>
 Strong communication and presentation skills; and
 </li>
 <li>
 Must be detail-oriented and efficient in time management.
 
 
 </li>
 </ul>
 
 
 
 
 
 Medpace Overview
 
 
 
 Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
 
 
 
 Why Medpace?
 
 
 
 People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
 
 
 The work we&rsquo;ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
 
 
 
 Medpace Perks
 
 
 
 <ul>
 <li>
 Flexible work environment
 </li>
 <li>
 Competitive PTO packages &ndash; starting at 20+ days
 </li>
 <li>
 Company-sponsored employee appreciation events
 </li>
 <li>
 Employee health and wellness initiatives
 </li>
 <li>
 Competitive compensation and benefits package
 </li>
 <li>
 Structured career paths with opportunities for professional growth
 </li>
 <li>
 Discounts for local businesses
 
 
 </li>
 </ul>
 
 Awards
 
 
 
 <ul>
 <li>
 Named a Top Workplace in 2024 by The Cincinnati Enquirer
 </li>
 <li>
 Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
 </li>
 <li>
 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
 
 
 </li>
 </ul>
 
 What To Expect Next
 
 
 
 A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
 
 
</div>

Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

KPS Life

<div><div>Opportunity Details
</div><div><div><div><div>On Assignment</div>
Clinical Oversight Manager (COM) - USA West Coast
 </div><div></div><div>Remote NE USA</div><div> 
</div></div></div><div>The primary responsibility of the (Clinical) Oversight Manager (C)OM) is to ensure adequate Sponsor oversight of 
the conduct, monitoring and management of one or more clinical studies and assigned monitors at clinical study 
sites, within the assigned country or region. 
The (C)OM):<ul><li>
contributes to development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan.</li><li>
contributes to the definition of appropriate standards and quality indicators for site management and monitoring.</li><li>
ensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards.
</li><li>addresses issues identified with study conduct, monitoring and site management with Sponsor&rsquo;s management, are appropriately communicated/escalated and follows up through resolution.</li><li>
May conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed.</li><li>
reviews the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region.</li><li>
may assist with translations or verification of translations.</li><li>
implements approved communication plans with external strategic partners or CROs.</li><li>
supports the collection of key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality.</li><li>
reviews monitoring visit reports for finalization/consistency/issues according to study monitoring plan.</li><li>
utilizes available tools/systems to assess vendor and site performance.</li><li>
ensures inspection readiness at the study sites and follow up corrective/preventive actions.</li><li>
maintains good communication and working relationships with investigators, internal stake-holders and external services providers (CROs).</li><li>
provide input into study feasibility for assigned sites/countries/region and supports the on-time delivery of a clinical study data, globally (if applicable</li></ul> 
The (C)OM) will have:<ul><li>
computer literacy in appropriate software(s).</li><li>
the ability to work well within a matrix environment with excellent interpersonal (written and verbal) and decision-making skills.</li><li>
demonstrated innovation skills, drive, energy and enthusiasm to deliver the study program objectives.</li><li>
demonstrated management of all clinical study aspects (developing a protocol to clinical study report).</li><li>
the ability to identify, solve and escalate issues that arise at study sites and within site management</li><li>
comprehensive/extensive knowledge of ICH guidelines/GCP and remains current on medical/scientific aspects.</li><li>
demonstrated project management skills i.e. (simultaneous management of multiple vendors, sites and studies. Possesses excellent planning, time management and coordination skills.</li><li>
demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.</li></ul>
The (C)OM) will have:<ul><li>
a degree (BSc/MSc or equivalent preferred) in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area.<ul><li>
other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).<ul><li>
a minimum of 8+ years&rsquo; relevant clinical research (or related) experience.</li><li>
6+ years&rsquo; experience in monitoring and site management of industry sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent).</li><li>
a thorough understanding of the drug development and clinical trial process.</li><li>
the ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary.</li><li>
the ability to participate in preparation, conduct and follow up of audits and site inspections.</li><li>
active management experience of countries and sites in a region.</li><li>
thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.</li></ul></li></ul></li></ul></div></div>

Clinical Oversight Manager (COM)

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Clinical Oversight Manager (COM)