4,634 Study Start Up Specialist jobs in the United States
Clinical Study Specialist
27722 Durham, North Carolina
Parexel
Posted today
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Job Description
**PXL has an exciting opportunity for a Clinical Study Specialist!**
The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
**CSS Duties**
+ Organizes and delivers analyzable reports and metrics to the clinical study lead
+ Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
+ Collates data for assessments such as feasibility and site selection and reviews site usability database
+ Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
+ Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
+ Collates materials for training and investigator meetings
+ Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
+ Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
+ Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
+ Supports receipt of scheduled reports (i.e. 1572 reportable changes, financial disclosure form)
+ Manages and maintains team SharePoint and/or shared drive sites, as needed
+ Communication with sites as directed and maintains site contact information
+ Contributes to line listings review for Blind Data Review Meeting (BDRM)
+ May manage or contribute to oversight of Third Party Vendors (TPV)
+ Tracks and monitors close out activities - study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
+ Proactively recommends process improvement initiatives for the department
+ May require 25% travel
**CSS** **requirements**
+ Bachelor's degree (or equivalent) and a minimum of 2+ years' industry related work experience or an advanced degree in a related field with a minimum of one (1) to two (2) years of relevant work preferred.
+ Attention to details for the ability to track information and deliver on assigned study activities
+ Good communication and interpersonal skills; ability to build relationships internally and externally
+ Ability to be resourceful and to demonstrate problem solving skills
+ Demonstrate the ability to proactively assess information and investigate impact on clinical trials
+ Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
+ Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
+ Basic familiarity with medical terms and clinical drug development
#LI-KW1
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
**CSS Duties**
+ Organizes and delivers analyzable reports and metrics to the clinical study lead
+ Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
+ Collates data for assessments such as feasibility and site selection and reviews site usability database
+ Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
+ Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
+ Collates materials for training and investigator meetings
+ Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
+ Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
+ Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
+ Supports receipt of scheduled reports (i.e. 1572 reportable changes, financial disclosure form)
+ Manages and maintains team SharePoint and/or shared drive sites, as needed
+ Communication with sites as directed and maintains site contact information
+ Contributes to line listings review for Blind Data Review Meeting (BDRM)
+ May manage or contribute to oversight of Third Party Vendors (TPV)
+ Tracks and monitors close out activities - study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
+ Proactively recommends process improvement initiatives for the department
+ May require 25% travel
**CSS** **requirements**
+ Bachelor's degree (or equivalent) and a minimum of 2+ years' industry related work experience or an advanced degree in a related field with a minimum of one (1) to two (2) years of relevant work preferred.
+ Attention to details for the ability to track information and deliver on assigned study activities
+ Good communication and interpersonal skills; ability to build relationships internally and externally
+ Ability to be resourceful and to demonstrate problem solving skills
+ Demonstrate the ability to proactively assess information and investigate impact on clinical trials
+ Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
+ Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
+ Basic familiarity with medical terms and clinical drug development
#LI-KW1
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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0
Home Study Specialist 25-49 - FT - Kona
Hawaii, Hawaii
Catholic Charities Hawai'i
Posted today
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Job Description
For description, see PDF:
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1
Pharmaceutical Research Scientist
20500 Washington, District Of Columbia
$110000 Annually
WhatJobs
Posted 6 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical innovator, is seeking a highly skilled Pharmaceutical Research Scientist to join their cutting-edge R&D team in Washington, D.C., US . This position involves extensive laboratory work focused on the discovery and development of novel therapeutic compounds. The ideal candidate will possess a strong background in medicinal chemistry, pharmacology, or a related discipline, coupled with hands-on experience in experimental design, execution, and data analysis. You will be responsible for advancing drug candidates through the preclinical pipeline, contributing significantly to the development of life-saving medications.
Responsibilities:
Qualifications:
Responsibilities:
- Design and conduct in vitro and in vivo experiments to evaluate the efficacy and safety of drug candidates.
- Synthesize and characterize potential drug molecules using modern organic chemistry techniques.
- Analyze experimental data, interpret results, and prepare comprehensive reports.
- Collaborate with multidisciplinary teams including biologists, toxicologists, and clinical scientists.
- Contribute to the writing of research papers, patents, and regulatory submissions.
- Maintain accurate and detailed laboratory notebooks and records.
- Stay updated with the latest scientific literature and advancements in pharmaceutical research.
- Operate and maintain sophisticated laboratory equipment.
Qualifications:
- Ph.D. in Pharmaceutical Sciences, Medicinal Chemistry, Pharmacology, Biochemistry, or a related field.
- Minimum of 5 years of postdoctoral or industry research experience in drug discovery.
- Proven experience in designing and executing complex biological assays and/or small molecule synthesis.
- Strong understanding of drug development processes and regulatory requirements.
- Excellent analytical, problem-solving, and critical thinking skills.
- Proficiency in relevant scientific software and databases.
- Excellent written and verbal communication skills.
- Ability to work effectively in a team-oriented, fast-paced environment at our Washington, D.C., US facility.
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2
Pharmaceutical Research Scientist
85001 Whispering Pines, Arizona
$120000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a talented and dedicated Pharmaceutical Research Scientist to contribute to groundbreaking drug discovery and development efforts in Phoenix, Arizona, US . This role will involve conducting advanced research, designing and executing experiments, and analyzing complex data to identify and validate novel therapeutic targets. The ideal candidate will possess a strong scientific background, extensive laboratory experience, and a deep understanding of medicinal chemistry, pharmacology, or related disciplines. Responsibilities include planning and executing in vitro and in vivo studies, developing and optimizing assay methodologies, interpreting experimental results, troubleshooting technical challenges, and preparing detailed reports and presentations for scientific audiences and management. You will collaborate closely with interdisciplinary teams of chemists, biologists, and clinicians, contributing to the progression of drug candidates through the preclinical pipeline. A Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Biology, or a closely related field is required, along with a minimum of 3-5 years of postdoctoral or industry research experience in drug discovery. Proven expertise in relevant research techniques (e.g., molecular biology, cell culture, biochemistry, high-throughput screening) and a strong publication record are essential. Excellent analytical, problem-solving, and critical thinking skills are a must. The candidate should be highly organized, detail-oriented, and capable of working independently while also thriving in a collaborative team environment. This is a unique opportunity to contribute to the development of life-saving medicines and advance your career in a dynamic and innovative research setting. Competitive salary and comprehensive benefits package are offered.
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3
Pharmaceutical Research Scientist
78701 Austin, Texas
$120000 Annually
WhatJobs
Posted 8 days ago
Job Viewed
Job Description
Our client is seeking a highly innovative and experienced Pharmaceutical Research Scientist to join their world-class, fully remote R&D team. This position is central to driving the discovery and development of novel therapeutics. You will conduct cutting-edge research, design and execute experiments, analyze complex data, and contribute to the advancement of our drug pipeline. This is a remote-first role, offering an exceptional opportunity to contribute to life-changing medical advancements from anywhere within the US.
Key Responsibilities:
Key Responsibilities:
- Design and perform laboratory experiments to investigate biological pathways and disease mechanisms relevant to drug discovery.
- Develop and optimize assays for screening potential drug candidates.
- Analyze and interpret complex experimental data using statistical and bioinformatics tools.
- Contribute to the development of research strategies and project plans.
- Maintain accurate and detailed laboratory notebooks and records.
- Stay current with the latest scientific literature and advancements in pharmaceutical research.
- Collaborate effectively with a multidisciplinary team of scientists, chemists, and clinicians.
- Prepare research reports, presentations, and contribute to scientific publications and patent applications.
- Troubleshoot experimental issues and propose solutions to ensure research continuity.
- Ensure compliance with all safety regulations and laboratory best practices.
- Ph.D. in Pharmacology, Biochemistry, Molecular Biology, or a related life science discipline.
- Minimum of 4 years of post-doctoral or industry research experience in drug discovery.
- Proven expertise in (mention specific relevant fields, e.g., oncology, immunology, neuroscience, infectious diseases).
- Hands-on experience with a variety of molecular and cellular biology techniques (e.g., Western blotting, PCR, cell culture, flow cytometry).
- Strong analytical and quantitative skills with experience in data analysis software (e.g., GraphPad Prism, R).
- Excellent written and verbal communication skills, with a track record of scientific presentations.
- Ability to work independently, manage multiple projects, and troubleshoot effectively in a remote research setting.
- Demonstrated ability to work collaboratively in a team environment.
- Familiarity with in vivo models and PK/PD studies is a plus.
- Must have a dedicated home laboratory space with the necessary equipment and connectivity, or willingness to establish one.
Note: The need for specific laboratory equipment will be assessed on a case-by-case basis for remote hires.
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4
Pharmaceutical Research Scientist
98101 Seattle, Washington
$95000 Annually
WhatJobs
Posted 8 days ago
Job Viewed
Job Description
Our client, a leading biopharmaceutical company, is seeking a talented and innovative Pharmaceutical Research Scientist to join our dedicated research and development team. This role focuses on the discovery and development of novel therapeutic agents. You will be involved in all stages of the drug discovery pipeline, from target identification and validation to lead optimization and preclinical testing. Responsibilities include designing and conducting experiments, analyzing complex biological data, and interpreting results to guide research direction. You will be expected to stay abreast of the latest scientific literature and technological advancements in relevant therapeutic areas. Collaboration with cross-functional teams, including medicinal chemists, biologists, pharmacologists, and clinical scientists, will be essential for project success. The ideal candidate will possess a strong background in molecular biology, biochemistry, pharmacology, or a related life science discipline. Experience with cell-based assays, high-throughput screening, and various analytical techniques is required. A Ph.D. or Master's degree in a relevant scientific field is essential, along with a proven track record of scientific productivity demonstrated through publications and presentations. Strong critical thinking, problem-solving abilities, and excellent communication skills are necessary. This role offers a stimulating environment where you can contribute to the development of life-changing medicines. We are looking for a highly motivated individual with a passion for scientific inquiry and a commitment to advancing human health. Experience in a specific therapeutic area such as oncology, immunology, or neurology is a plus. Proficiency in data analysis software and laboratory information management systems (LIMS) is desirable.
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5
Pharmaceutical Research Scientist
92101 San Diego Country Estates, California
$90000 Annually
WhatJobs
Posted 8 days ago
Job Viewed
Job Description
Our client, a leading innovator in the pharmaceutical industry, is looking for a dedicated and highly skilled Pharmaceutical Research Scientist to join their cutting-edge, remote-based research team. This role is instrumental in driving the discovery and development of novel therapeutics. You will be responsible for designing and executing complex experiments, analyzing data, and interpreting results to advance drug discovery projects. The ideal candidate will possess a strong background in molecular biology, biochemistry, pharmacology, or a related field, with a proven ability to contribute to research initiatives. Key responsibilities include literature reviews, hypothesis generation, experimental planning, and execution of in-vitro and in-vivo studies. You will work collaboratively with a multidisciplinary team of scientists, contributing to project goals and advancing research pipelines. Excellent analytical, critical thinking, and problem-solving skills are essential, as is the ability to meticulously document research findings and present them clearly. This is a fully remote position, requiring strong self-discipline, effective virtual communication, and the ability to work independently while staying connected with the team. Experience with specific research techniques, data analysis software, and regulatory guidelines (e.g., GLP) is highly desirable. Join us in our mission to develop life-changing medicines from your remote workspace, contributing to advancements impacting global health from the vibrant scientific hub of San Diego, California, US .
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6
Pharmaceutical Research Scientist
92101 San Diego Country Estates, California
$120000 Annually
WhatJobs
Posted 8 days ago
Job Viewed
Job Description
Our client, a leader in pharmaceutical innovation, is seeking a highly skilled and dedicated Pharmaceutical Research Scientist to join their cutting-edge laboratory in **San Diego, California, US**. This position offers an exciting opportunity to contribute to the discovery and development of novel therapeutics. The successful candidate will be responsible for designing, conducting, and analyzing complex experiments in areas such as drug discovery, molecular biology, or pharmacology. You will play a critical role in advancing our research pipeline, from target identification and validation to preclinical candidate selection. Responsibilities include managing laboratory operations, ensuring compliance with safety protocols, and maintaining meticulous experimental records. The ideal candidate will have a Ph.D. or Master's degree in a relevant scientific discipline (e.g., Molecular Biology, Biochemistry, Pharmacology) and a minimum of 5 years of postdoctoral or industry research experience. Proven expertise in specific assay development, cell culture techniques, protein chemistry, or relevant animal models is required. Strong analytical skills, proficiency in data interpretation, and the ability to troubleshoot complex scientific problems are essential. Excellent written and verbal communication skills are necessary for presenting research findings at internal meetings and potentially at scientific conferences. Experience with scientific literature review and grant writing is a plus. You will work collaboratively with a team of scientists and technicians, contributing to a culture of scientific excellence and innovation. This role demands a proactive, detail-oriented individual with a passion for scientific inquiry and a commitment to advancing human health. Join our world-class research team and make a tangible difference in the lives of patients worldwide.
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7
Pharmaceutical Research Scientist
90001 Los Angeles, California
$95000 Annually
WhatJobs
Posted 8 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical innovator, is seeking a talented and driven Pharmaceutical Research Scientist to join their cutting-edge R&D facility in Los Angeles, California . This role is pivotal in discovering and developing novel therapeutic agents to address unmet medical needs. You will be involved in all stages of the drug discovery process, from target identification and validation to lead optimization and preclinical development. The ideal candidate will possess a strong scientific background in pharmacology, biochemistry, or a related field, with extensive hands-on laboratory experience. Expertise in specific therapeutic areas and advanced analytical techniques is highly desirable. You will collaborate closely with a multidisciplinary team of scientists, clinicians, and project managers, contributing to a dynamic and collaborative research environment. Responsibilities include:
Candidates should hold a Ph.D. in Pharmacology, Biochemistry, Molecular Biology, or a closely related discipline, with a minimum of 3 years of postdoctoral or industry research experience. Demonstrated experience in drug discovery, assay development, and data analysis is essential. Strong understanding of disease mechanisms and therapeutic strategies is required. Excellent analytical, problem-solving, and critical thinking skills are a must. Superior written and verbal communication skills, with the ability to present complex scientific information clearly and concisely, are necessary. Experience with common laboratory techniques, such as PCR, Western blotting, ELISA, cell culture, and animal models, is expected. Familiarity with statistical analysis software and bioinformatics tools is a plus. This is an exciting opportunity to make a significant impact in pharmaceutical innovation and patient care.
- Designing and executing complex experiments to identify and validate new drug targets.
- Developing and optimizing assays for high-throughput screening and lead compound evaluation.
- Conducting in vitro and in vivo studies to assess the efficacy and safety of potential drug candidates.
- Analyzing and interpreting experimental data, and preparing comprehensive reports.
- Contributing to the development of intellectual property and patent filings.
- Collaborating with medicinal chemists, biologists, and pharmacologists to advance drug discovery programs.
- Staying abreast of the latest scientific literature and technological advancements in pharmaceutical research.
- Presenting research findings at internal meetings and scientific conferences.
- Ensuring compliance with all laboratory safety protocols and regulatory guidelines.
Candidates should hold a Ph.D. in Pharmacology, Biochemistry, Molecular Biology, or a closely related discipline, with a minimum of 3 years of postdoctoral or industry research experience. Demonstrated experience in drug discovery, assay development, and data analysis is essential. Strong understanding of disease mechanisms and therapeutic strategies is required. Excellent analytical, problem-solving, and critical thinking skills are a must. Superior written and verbal communication skills, with the ability to present complex scientific information clearly and concisely, are necessary. Experience with common laboratory techniques, such as PCR, Western blotting, ELISA, cell culture, and animal models, is expected. Familiarity with statistical analysis software and bioinformatics tools is a plus. This is an exciting opportunity to make a significant impact in pharmaceutical innovation and patient care.
Apply Now
8
Pharmaceutical Research Scientist
53202 West Milwaukee, Wisconsin
$90000 Annually
WhatJobs
Posted 8 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly motivated and skilled Pharmaceutical Research Scientist to join their dynamic R&D team in Milwaukee, Wisconsin . This role offers a hybrid work arrangement, enabling a balance between focused laboratory work and flexible remote research activities. You will play a crucial role in the discovery and development of novel therapeutic agents. Your responsibilities will include designing and conducting experiments, analyzing complex biological data, and contributing to the interpretation of research findings. You will collaborate with a multidisciplinary team of scientists, chemists, and clinicians to advance drug candidates through the preclinical pipeline. The ideal candidate will possess a Ph.D. or Master's degree in Pharmacology, Biochemistry, Molecular Biology, or a related life science discipline, with a strong track record of research accomplishments in drug discovery. Hands-on experience with relevant laboratory techniques, such as cell-based assays, molecular biology methods, and biochemical assays, is required. Proficiency in data analysis and interpretation, including statistical analysis, is essential. Excellent written and verbal communication skills are necessary for preparing scientific reports, presenting findings, and collaborating effectively. The hybrid nature of this position allows for intensive laboratory work during on-site days, interspersed with remote periods for data analysis, literature review, and report writing. Our client is dedicated to innovation in pharmaceutical research and is developing groundbreaking treatments for unmet medical needs. This is an exceptional opportunity to contribute to meaningful scientific advancements, work with state-of-the-art technology, and grow your career within a highly reputable organization. You will be an integral part of a team focused on improving patient outcomes through innovative drug development. The ability to work independently and as part of a team, with a strong commitment to scientific rigor and ethical conduct, is paramount. Our client offers a competitive salary, comprehensive benefits, and opportunities for continuous learning and professional development.
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