5,060 Study Start Up Specialist jobs in the United States

Job Title: Healthcare Clinical Study Specialist
Job Description
A Clinical Study Specialist coordinates and oversees clinical operations of research projects, ensuring compliance with established organizational policies, Good Clinical Practices, and clinical research protocols. The role involves assessing and evaluating subject safety under the general supervision of the Principal Investigator or Clinical Research Manager.
Responsibilities
+ Obtain and review records for potential research subjects and maintain study records including documentation of procedures and progress.
+ Review recruited clinical study subjects for eligibility, schedule appointments, and evaluate potential subjects.
+ Instruct potential research subjects, responsible family members, nursing staff, and ancillary staff on study procedures, treatments, and side effects.
+ Educate subjects on protocol and informed consent procedures, including obtaining written consent.
+ Evaluate and assist in developing subject education materials and instruct subjects and/or family members on test article administration and other study information.
+ Perform nursing assessments and monitor subjects' progress during clinical studies, notifying PI/CRM of any adverse events.
+ Conduct initial interviews during each subject visit and plan appropriate procedures according to the protocol.
+ Set-up and verify instruments required for studies and conduct studies with these instruments, assembling data for analysis.
+ Troubleshoot simple equipment or instrumentation issues as necessary.
+ Coordinate research activities and procedures for study subjects.
+ Complete case report forms for each study participant and document study data in subject study files.
+ Assess and document compliance of research subjects.
+ Provide orientation, information, training, and assistance for new and existing personnel and research assistants.
+ Participate in staff meetings and in-service education.
+ Maintain an adequate inventory of research supplies necessary for research activities.
+ Maintain exam rooms and equipment.
Essential Skills
+ Licensed health care professional such as RN, LPN, or Radiological Technologist.
+ One year of experience in a Clinical Research setting preferred.
+ Excellent oral and written communication skills.
+ High degree of empathy for subjects.
+ Ability to work independently.
+ Strong problem-solving abilities.
+ Understanding of OSHA guidelines for handling hazardous biological and chemical materials.
Additional Skills & Qualifications
+ Experience with clinical trials and studies.
+ Ability to provide orientation and training to research staff.
Work Environment
The position is located onsite with a set pay rate of $40.00 per hour. Hours vary based on business needs, and there is no guarantee of a set number of hours each week. Availability is required for at least three days a week, with a preference for availability all five days, Monday through Friday. Typical office hours are between 7 am and 4 pm.
Job Type & Location
Neenah, Wisconsin
Pay and Benefits
The pay range for this position is $0.00 - 40.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Neenah,WI.
Application Deadline
This position is anticipated to close on Aug 29, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.

For description, see PDF:

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Key responsibilities include:

• Designing, optimizing, and conducting in vitro and in vivo experiments to evaluate drug candidates.
• Analyzing experimental data using statistical and bioinformatics tools.
• Developing and validating new assays and experimental methodologies.
• Contributing to the interpretation of results and preparation of research reports.
• Collaborating effectively with cross-functional teams, including medicinal chemists and pharmacologists.
• Maintaining detailed laboratory notebooks and documentation of research activities.
• Presenting research findings at internal meetings and scientific conferences.
• Ensuring compliance with laboratory safety protocols and good laboratory practices (GLP).
• Staying current with scientific literature and emerging technologies in the field.
• Troubleshooting experimental issues and proposing solutions.

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• Design, execute, and interpret complex experiments to support drug discovery and development.
• Develop and validate new assays and methodologies.
• Analyze experimental data using appropriate statistical methods and software.
• Contribute to the preparation of scientific reports, manuscripts, and patent applications.
• Collaborate with cross-functional teams, including chemists, biologists, and clinicians.
• Maintain detailed and accurate laboratory records according to GLP standards.
• Stay current with scientific literature and emerging technologies in the pharmaceutical field.
• Troubleshoot experimental procedures and resolve technical challenges.
• Present research findings at internal and external scientific meetings.

Qualifications:

• Ph.D. or Master's degree in Pharmacology, Medicinal Chemistry, Molecular Biology, Biochemistry, or a related life science discipline.
• Minimum 3-5 years of post-doctoral or industry experience in pharmaceutical research and development.
• Proven track record in drug discovery, with experience in assay development, in vitro/in vivo studies.
• Expertise in specific therapeutic areas is highly desirable.
• Proficiency in relevant laboratory techniques and instrumentation.
• Strong analytical skills and experience with statistical software (e.g., GraphPad Prism, R).
• Excellent written and verbal communication skills, with a strong publication record.
• Ability to work independently and collaboratively in a research-intensive environment.
• Knowledge of regulatory requirements (e.g., FDA, EMA) and GLP is essential.

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• Design, execute, and analyze experiments related to drug discovery and development.
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• Stay current with the latest scientific literature and technological advancements in the field.
• Contribute to the preparation of regulatory documents and patent applications.
• Ensure adherence to all laboratory safety protocols and good laboratory practices (GLP).

Qualifications:

• Ph.D. or Master's degree in Pharmacology, Medicinal Chemistry, Biochemistry, Molecular Biology, or a closely related field.
• Minimum of 3-5 years of post-doctoral or industry research experience in drug discovery.
• Proven experience in a specific area of pharmaceutical research (e.g., oncology, immunology, neuroscience).
• Strong hands-on laboratory skills and expertise in relevant experimental techniques.
• Proficiency in data analysis software and scientific literature databases.
• Excellent written and verbal communication skills, with a track record of scientific publications.
• Ability to work independently and as part of a collaborative research team.
• Strong problem-solving skills and a creative approach to scientific challenges.
• Experience with high-throughput screening (HTS) is a plus.
• Familiarity with early-stage drug development processes.

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