clinical research scientist

bioMerieux

<div>The Clinical Research Scientist (CRS) leads the execution of the clinical studies that make up the company&rsquo;s clinical evidence generation program. In this role, you will execute clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
The Clinical Research Scientist collaborates closely with cross-functional teams, including associate Clinical Research Scientists, Disease State Scientists, Biostatistics &amp; Data Management, Logistics, Medical Writers, Regional Medical Affairs teams and other stakeholders to generate impactful clinical evidence that supports the company&rsquo;s strategy. This role is crucial in maintaining our commitment to scientific excellence and patient-centric approaches within the competitive global healthcare landscape. 
This position can be located in either St. Louis, MO OR Salt Lake City, UT.
Primary Duties
Team and Cross Functional Leadership: 
a. Leads the study team in the execution of clinical studies to meet the Evidence Generation Plan from study synopsis to data lock and final study report 
b. Partner with internal stakeholders to lead the development, review, and finalization of clinical protocols to meet regulatory and scientific objectives 
c. Contribute to the development of the study synopsis 
d. Partner with key stakeholders to create and manage the study execution team 
e. Collaborate closely with cross-functional teams including Regulatory Affairs, Quality Assurance, Biostatistics, Program Management, external vendors, and contract research organizations (CROs) to ensure high-quality study conduct 
f. Mentor Associate Clinical Research Scientist(s) and provide guidance on clinical operations processes, study management and other study execution tasks
Study Planning, Strategy and Reporting: 
a. Develop and manage study budgets, timelines, enrollment strategies, and resourcing requirements to ensure study milestones are met 
b. Develop and manage all required plans including clinical study project plans, study execution plans, risk and risk mitigation plans, monitoring plan, and communication plans 
c. Contributes to or leads the development of abstracts/posters of study results in collaboration with study team 
d. Develop clinical study reports and/or contribute to the development of scientific publications
Study Management and Site Management: 
a. Manage all aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out for bioM&eacute;rieux initiated research studies and collaborative studies 
b. Track study progress and provide regular status reports to stakeholders 
c. Assure study metrics and budget are input to corporate systems 
d. Oversee site selection, feasibility, study startup, site activation, enrollment, and ongoing execution 
e. Oversee clinical monitoring and data integrity 
f. Update trial management systems, including timelines and budgets 
g. Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits as required 
h. Oversee clinical site activities, reference laboratories, CROs, and other external partners to ensure adherence and compliance with protocol timelines, budgets, study milestones and quality standards 
i. Manage and coordinate IRB/EC document creations and communications 
j. Manage clinical trial agreements for sites 
k. Manage study documentation and filing with electronic trial master file (eTMF) platforms
Regulatory Compliance: 
a. Follow Corporate (e.g., SOP&rsquo;s) and local/regional regulatory requirements 
b. Participate in the review and revision of Clinical Operations Standard Operating Procedures (SOPs) to assist Medical Affairs leadership with continuous process improvement initiatives
Quality and Compliance: 
a. Identify and mitigate risks throughout the clinical trial lifecycle 
b. Assure a quality plan is in place
Data Management: 
a. Oversee and manage electronic data capture (EDC) systems 
b. Oversee data collection activities, compliance, and inspection readiness 
c. Oversee electronic trial master file (eTMF) platforms to ensure data integrity and regulatory compliance
Communication: 
a. Lead internal and external study meetings with relevant stakeholders 
d. Organize and drive study meetings and other study activities as assigned 
e. Participate in core team meetings to provide clinical insights and contribute to strategic decision-making 
f. Outline and communicate safety issues and planned mitigations in collaboration with internal stakeholders
Vendor management: 
a. Negotiate contracts and budgets in partnership with the legal team 
b. Manage clinical trial agreements with external vendors 
c. Manage vendor performance according to contract
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.
Experience<ul><li>
Bachelor's Degree required in a scientific, medical, or healthcare discipline</li><li>
2+ years of professional related experience in clinical trial management, preferably in diagnostics or medical device required.</li><li>
Certifications including ACRP-CP or ACRP-PM a plus.
</li><li>Excellent knowledge of clinical trial processes, systems, and tools (e.g., CTMS, EDC, eTMF), with the ability to oversee quality, data integrity, and inspection readiness.
</li><li>Proven leadership and stakeholder-management capabilities, with the ability to influence without authority and build strong relationships across functions and with external partners.
</li><li>Experience negotiating clinical research contracts and budgets
</li><li>Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
</li><li>Experience managing all major aspects of strategic planning, organization, implementation, and delivery of clinical studies.
</li><li>Understanding the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO)
</li><li>Proven track record writing clinical study plans and study protocols
</li><li>Experience with the study budget oversight, risk mitigation, management of timelines, deliverables, and milestones
</li><li>Experience negotiating clinical research contracts and budgets with Investigators and sites
</li><li>Experience with electronic clinical trial systems and clinical data review
</li></ul>Knowledge, Skills, &amp; Abilities<ul><li>
Consistently upholds and reflects the core ethical principles and values that bioM&eacute;rieux promotes.</li><li>
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives</li><li>
Effective Presentation Skills - including the ability to present technical data</li><li>
Solution oriented in the face of conflict</li><li>
Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently</li><li>
Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs.</li><li>
Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
</li><li><ul><li>Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently</li></ul></li><li>
Functionally Required Knowledge, Skills, and Abilities
</li><li><ul><li>Ability to manage budget, timelines and multiple projects simultaneously</li><li>
Ability to learn new products and adjust to changing research directions</li></ul></li></ul><div>
The estimated salary range for this role is between $80,000 and $116,700. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux&rsquo;s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate&rsquo;s experience and will be presented in writing at the time of the offer.</div><div>
In addition, bioM&eacute;rieux offers a competitive Total Rewards package that may include:</div><ul><li>A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options</li><li>Company-Provided Life and Accidental Death Insurance</li><li>Short and Long-Term Disability Insurance</li><li>Retirement Plan including a generous non-discretionary employer contribution and employer match.</li><li>Adoption Assistance</li><li>Wellness Programs</li><li>Employee Assistance Program</li><li>Commuter Benefits</li><li>Various voluntary benefit offerings</li><li>Discount programs</li><li>Parental leaves</li></ul><div>
</div><div>
#LI-US</div></div>

Clinical Research Scientist

Abbott

<div>Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Senior Clinical Research Scientist
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You&rsquo;ll also have access to:<ul><li>
Career development with an international company where you can grow the career you dream of.</li><li>
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.</li><li>
An excellent retirement savings plan with high employer contribution</li><li>
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor&rsquo;s degree.</li><li>
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.</li><li>
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.</li></ul>
The Opportunity
This position works out of our St. Paul, MN or Plymouth, MN location in the Electrophysiology division. In Abbott&rsquo;s Electrophysiology (EP) business, we&rsquo;re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
As the Senior Clinical Research Scientist you will lead scientific activities associated with the design, conduct, and reporting of clinical trials for this therapeutic area. This position will participate in the development of clinical evidence to establish feasibility, achieve regulatory approvals, meet ongoing regulatory requirements, gain reimbursement, and support full commercial adoption of medical devices. You will support the analysis and interpretation of scientific data and write clinical study protocols, reports, and scientific publications. You will aid in the production of additional study-level documents including informed consent forms, case report forms, and investigator brochures. In this role, you will interact with physician Key Opinion Leaders and various cross-functional teams, including Marketing, R&amp;D, Field Operations, Risk Management, Reimbursement, Medical Affairs, Quality, and Regulatory Affairs. You will also interact with global regulatory agencies to obtain market approval of new products, and with study sites to respond to questions throughout the study.
What You&rsquo;ll Work On<ul><li>
Participate in clinical trial design, protocol development, and publication planning.</li><li>
Generate and execute study-level publication projects.</li><li>
Prepare clinical study reports or report sections.</li><li>
Support regulatory submissions.</li><li>
Facilitate communication between Sales and Marketing, R&amp;D, Program Management, Reimbursement, Medical Affairs, Risk Management, Quality and Regulatory Affairs, and investigational sites.</li><li>
Oversee study Steering Committees and Publication Committees, consisting of physician Key Opinion Leaders globally.</li><li>
Present clinical study results to senior leaders and at investigator meetings.</li><li>
Participate in and support audits.</li></ul>
Required Qualifications<ul><li>
Advanced degree in the sciences, medicine, or similar discipline.</li><li>
4+ years of clinical research work experience post-degree.</li><li>
Demonstrated scientific writing ability.</li><li>
Ability to plan and organize project assignments of substantial variety and complexity.</li><li>
Ability to be innovative, resourceful, and work with minimal direction.</li><li>
Excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams.</li><li>
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.</li><li>
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.</li><li>
Strong organizational and follow-up skills, as well as attention to detail</li></ul>
Preferred Qualifications<ul><li>
Experience in the medical device industry.</li><li>
Experience with international medical device regulations and submissions.</li><li>
Familiarity with relevant international regulatory requirements for medical devices including Quality Systems standards and clinical investigations.</li><li>
Experience working in a quality system environment preferred.</li></ul>
Apply Now 
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. 
The base pay for this position is $78,000.00 &ndash; $156,000.00. In specific locations, the pay range may vary from the range posted.</div>

Senior Clinical Research Scientist

Mount Sinai Health System

<div>Description
The Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai is dedicated to delivering superior, comprehensive dermatologic care that exceeds patient expectations, and to advancing the science of dermatology through research and education. 


From preparing the next generation of leaders, to providing cutting-edge and cost-effective treatment, the Department of Dermatology thrives on a passion to improve the lives of patients through science. 


The Research Scientist II is a senior-level laboratory or clinical research individual who conducts research involving the understanding of human diseases and the improvement of human health. S/he engages in clinical investigation or other research, production, technical writing, and related activities. The Research Scientist II make take the lead in the creation or participation of specific research projects. 
Responsibilities<ul><li>
Conducts research to develop methodologies, instrumentation and procedures for medical application, analyzing data and presenting findings.</li><li>
Assists in the design and conduct of complex clinical research studies requiring the determination and evaluation of alternative methods, computational modeling, diagnosis and treatment.</li><li>
Participates in studies to investigate human or animal disease, preventive methods, and treatments for disease.</li><li>
Follows strict safety procedures when handling materials to avoid contamination.</li><li>
May mentor students and less experienced research technicians.</li><li>
May confer with health departments, industry personnel, physicians, and others to develop health safety standards and public health improvement programs.</li><li>
Develops treatments and designs research tools and techniques.</li><li>
Explores subject area and defines scope and selection of problems for investigation through conceptually related studies.</li><li>
Develops hypotheses with senior colleagues to be tested and methodology for evaluating results.</li><li>
Examines the results of clinical trials and adjusts the dosage levels to reduce negative side effects or to induce better results.</li><li>
Develops new proposals for research and obtain support for new and/ or continuing research activities.</li><li>
Participates or leads the process in decision-making with potential impact on extensive scientific research activities.</li><li>
May present at relevant professional conferences.</li><li>
Other duties as assigned.</li></ul> 

Qualifications<ul><li>
Master&rsquo;s or Ph.D in Biological Science or related field is strongly preferred.</li><li>
3+ years minimum research experience (may include academic studies) with Masters; 5 years with a Bachelor&rsquo;s. Prior Faculty background preferred. Supervisory experience of lower-ranked research personnel is preferred.</li></ul> 

Employer Description
Strength through Unity and Inclusion

The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai&rsquo;s unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.

At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.

About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time &mdash; discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients&rsquo; medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News &amp; World Report's Best Hospitals, receiving high &quot;Honor Roll&quot; status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News &amp; World Report&rsquo;s &ldquo;Best Children&rsquo;s Hospitals&rdquo; ranks Mount Sinai Kravis Children's Hospital among the country&rsquo;s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek&rsquo;s &ldquo;The World&rsquo;s Best Smart Hospitals&rdquo; ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

Equal Opportunity Employer

The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization. 
Compensation
The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $87692 - $131538 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.</div>

Research Scientist II - Dermatology

New York University Abu Dhabi

<div>
 The Center for Brain and Health (CBH) (https://brainandhealth.org/) at New York University Abu Dhabi (NYUAD) is seeking a Research Scientist to explore scientific questions related to an in-progress normative brain database. The Research Scientist will be a key member of a multidisciplinary team responsible for collection, c, MEG, EEG, and eye tracking. The tentpole of the CBH is a normative brain database - the first of its kind in the region - that includes structural, functional, and diffusion MRI, behavioral and health measures, genetic information, and lifestyle questionnaires
 
 
 Candidates must hold a Ph.D. in Neuroscience, Psychology, MR Physics, Data Science, Computer Science, or a related field. Postdoctoral experience or equivalent is preferred. This position requires extensive experience with multimodal MRI, including functional and structural MRI and tractography. Experience with big data analysis techniques is essential. Experience working with other large brain databases is preferred. The ideal candidate will possess strong computational skills and a strong publication record. Terms of employment include competitive salary and benefits.
 
 
 Applications will be accepted immediately. To be considered, applicants need to submit a cover letter, curriculum vitae with full publication list, transcript, statement of research interests, three representative publications, and three letters of reference, all in PDF format. For instructions and information on how to apply, please visit our website at http://nyuad.nyu.edu/en/about/careers/faculty-positions.html. If you have any questions, please email rokers@nyu.edu or kartik.sreenivasan@nyu.edu
 
 
 The anticipated appointment starting date is May 1, 2026, with funding guaranteed for a term of 18 months and opportunity for renewal of the position for additional years following performance evaluation. The terms of employment include highly competitive salary, housing allowance, and other benefits.
 
 
 
 About NYU Abu Dhabi
 
 
 
 https://nyuad.nyu.edu/en/
 
 
 NYU Abu Dhabi is the first comprehensive liberal arts and research campus in the Middle East to be operated abroad by a major American research university. Times Higher Education ranks NYU among the top 30 universities in the world, making NYU Abu Dhabi the highest-ranked university in the UAE and MENA region. NYU Abu Dhabi has integrated a highly selective undergraduate curriculum across the disciplines with a world center for advanced research and scholarship. The university enables its students in the sciences, engineering, social sciences, humanities, and arts to succeed in an increasingly interdependent world and advance cooperation and progress on humanity&rsquo;s shared challenges. NYU Abu Dhabi&rsquo;s high-achieving students have come from over 120 countries and speak over 100 languages. Together, NYU's campuses in New York, Abu Dhabi, and Shanghai form the backbone of a unique global university, giving faculty and students opportunities to experience varied learning environments and immersion in other cultures at one or more of the numerous study-abroad sites NYU maintains on six continents.
 
 
 NYUAD is committed to upholding a culture of non-discrimination, anti-harassment, dignity, and mutual respect; providing equal access and opportunity; and fostering academic excellence in learning, research, and teaching.
 
 
 UAE Nationals are encouraged to apply.
 
 
 
 Equal Employment Opportunity Statement
 
 
 
 
 For people in the EU, click here for information on your privacy rights under GDPR: www.nyu.edu/it/gdpr
 
 
 
 NYU is an Equal Opportunity Employer and is committed to a policy of equal treatment and opportunity in every aspect of its recruitment and hiring process without regard to age, alienage, caregiver status, childbirth, citizenship status, color, creed, disability, domestic violence victim status, ethnicity, familial status, gender and/or gender identity or expression, marital status, military status, national origin, parental status, partnership status, predisposing genetic characteristics, pregnancy, race, religion, reproductive health decision making, sex, sexual orientation, unemployment status, veteran status, or any other legally protected basis. All interested persons are encouraged to apply for vacant positions at all levels.
 
 
 
 Sustainability Statement
 
 
 
 NYU aims to be among the greenest urban campuses in the country and carbon neutral by 2040. Learn more at nyu.edu/sustainability
</div>

Research Scientist in the Center for Brain and Health – Dr. Bas Rokers and Dr. Kartik Sreenivasan

Baylor Miraca Genetics Laboratories LLC

<div>We are seeking a highly motivated Scientist III to join our Assay R&amp;D team developing next‑generation clinical assays for rare disease diagnostics. In this role, you will design and optimize cutting‑edge DNA and RNA sequencing&ndash;based assays using a variety of input materials, including blood, saliva, and buccal swabs.

This position is ideal for an accomplished scientist with expertise in molecular biology, sequencing technologies, and clinical assay development who thrives in a fast‑paced, innovation‑driven environment.

Key Responsibilities
<ul>
<li>Lead the design, development, and optimization of sequencing-based clinical assays for rare disease detection.</li>
<li>Develop end-to-end workflows utilizing multiple sample types, including blood, saliva, and buccal swabs.</li>
<li>Design and execute experiments, analyze data, and interpret results to guide assay performance improvements.</li>
<li>Define assay performance metrics and collaborate with validation teams on verification and validation studies.</li>
<li>Work cross-functionally with bioinformatics, automation, validation, and clinical teams for successful assay transfer.</li>
<li>Maintain accurate experimental documentation in compliance with quality and regulatory standards.</li>
<li>Present scientific findings and contribute to reports and/or publications.</li>
<li>Stay current with emerging technologies and scientific trends to support innovation.</li>
</ul>
Required Qualifications
<ul>
<li>Ph.D. in molecular biology, biochemistry, genetics, or related field.</li>
<li>3+ years of hands-on experience in sequencing workflows and assay development, ideally in a clinical or diagnostic lab.</li>
<li>Expertise working with diverse sample types including blood, saliva, and buccal swabs.</li>
<li>Strong proficiency in molecular biology techniques (PCR, qPCR, NGS, nucleic acid extraction).</li>
<li>Experience with NGS data analysis tools and pipelines.</li>
<li>Excellent problem‑solving skills, attention to detail, and communication abilities.</li>
</ul>
Preferred Qualifications
<ul>
<li>Experience transferring R&amp;D assays into clinical or production operations.</li>
<li>Familiarity with regulated environments such as CLIA or CAP.</li>
<li>Experience with automated liquid handling systems.</li>
</ul>
Ability to rapidly learn and apply new technologies.

EEO Statement:

 Baylor Genetics is proud to be an equal opportunity employer dedicated to building an inclusive and diverse workforce. We do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, gender identity, veteran status, disability, genetic information, pregnancy, childbirth, or related medical conditions, or any other status protected under applicable federal, state, or local law.

Note to Recruiters:

We value building direct relationships with our candidates and prefer to manage our hiring process internally. While we occasionally partner with select recruitment agencies for specialized roles, we do not accept unsolicited resumes from recruiters or agencies without a written agreement executed by the authorized signatory for Baylor Genetics (&quot;Agreement&quot;). Any resumes submitted to Baylor Genetics in the absence of an Agreement executed by Baylor Genetics' authorized signatory, will be considered the property of Baylor Genetics, and Baylor Genetics will not be obligated to pay any associated recruitment fees.</div>

Research & Development Scientist III - Clinical Assay Development (Rare Disease Diagnostics)

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
This is a fully remote role supporting one of our key customers. We welcome applicants from all locations within the US.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission &ndash; to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
The Research Scientist acts as the sponsor representative/study monitor for one or more studies and supports the bioanalytical study phases of clinical trials.
Key responsibilities:<ul><li>
Reviews trial related documentation with a link to the GxP vendor (i.e., CTP, SAP, TLF&rsquo;s, CSR, Lab manual)</li><li>
Ensures the bioanalytical vendor receives copies of trial related documentation and relevant amendments (e.g., clinical trial protocol)</li><li>
Reviews and approves study plans of bioanalytical phases of clinical trials</li><li>
Reviews and approves (if applicable) bioanalytical reports</li><li>
Oversees planned and unplanned changes to study plan and vendor procedures are documented according to vendor procedures (e.g., in amendments and deviations) and are shared with the sponsor as stipulated in the quality agreement or communication plan</li><li>
Ensures that the Clinical Trial Team is adequately informed of the project status and that relevant information (e.g., end-of-study timelines and data delivery requirements) from the Clinical Trial Team is conveyed to the project manager and bioanalytical vendor</li><li>
Escalates issues related to timelines, budget or communication to the appropriate stakeholders</li><li>
Manages oversight documentation in eTMF</li><li>
Contributes to interactions with regulatory agencies (if applicable)</li></ul>
Education and Experience:<ul><li><ul><li>PhD in Immunology or Molecular Biology and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 4+ years</li></ul></li><li>
OR</li><li>
Master&rsquo;s Degree and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 6+ years</li><li>
OR</li><li>
Bachelor's Degree and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 8+ years</li></ul>
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:<ul><li>
Experience in managing outsourced activities at external vendors required</li><li>
Strong knowledge of bioanalytical techniques specifically in biologics and antibodies assays required &middot; Experience performing PK and ADA assays required</li><li>
Experience in analyzing human samples in support of clinical trials required</li><li>
Strong understanding of GCP/GCLP guidelines and other current global regulations required</li><li>
Experience with submission documentation and regulatory interactions</li><li>
Experience with clinical immunogenicity data interpretation, writing and reviewing the Integrated Summary of Immunogenicity (ISI) and clinical study report</li><li>
Experience drafting and reviewing bioanalytical modules (2.7.1, 2.7.2) and immunogenicity sections in regulatory documents either independently or collaboration with a medical writer</li></ul>
Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:<ul><li>
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.</li><li>
Able to work upright and stationary for typical working hours.</li><li>
Ability to use and learn standard office equipment and technology with proficiency.</li><li>
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</li></ul></div>

Research Scientist PI - Bioanalytical

James Grey International

A growing clinical research center in Dallas is seeking a physician interested in serving as a Principal Investigator for Phase II&ndash;IV clinical trials.This role offers a strong operational infrastructure, active study pipeline, and dedicated regulatory and recruitment support &mdash; allowing you to focus on medical oversight, patient safety, and protocol execution.Responsibilities<ul><li>Provide medical oversight for assigned clinical trials</li><li>Ensure participant safety and compliance with ICH/GCP guidelines</li><li>Evaluate patient eligibility and perform clinical assessments</li><li>Review enrollment metrics, safety data, and study progress</li><li>Collaborate with experienced coordinators and regulatory staff</li></ul>Qualifications<ul><li>MD or DO</li><li>Active Texas medical license</li><li>Strong general medical diagnostic proficiency</li><li>Prior clinical research experience preferred but not required</li></ul>Clinical experience within cardiometabolic, endocrine, or neurological therapeutic areas is a plus.What We Offer<ul><li>Competitive compensation</li><li>Flexible scheduling options</li><li>Established research infrastructure</li><li>Opportunity to grow within a nationally expanding research platform</li></ul>Pay: $120.00 - $150.00 per hourBenefits:<ul><li>401(k) matching</li><li>Flexible schedule</li><li>Health insurance</li><li>Malpractice insurance</li><li>Paid time off</li><li>Relocation assistance</li></ul>Education:<ul><li>Doctorate (Required)</li></ul>Experience:<ul><li>Clinical trials: 1 year (Required)</li></ul>License/Certification:<ul><li>Medical License (Texas) (Required)</li></ul>Ability to Commute:<ul><li>Irving, TX 75061 (Required)</li></ul>Work Location: In person

Physician - Clinical Research - Dallas, TX

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