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Clinical Study Specialist Jobs

Study Start Up Specialist
By DOCS At All, MO, United States
Strong collaborative and time management skills
Knowledge of CFR and ICH/GCP requirements is
A first solid SSU experience
Preferred previous experience of working in a CRO or pharma environment
Perform a variety of routine essential document collection, review, negotiate to ensure successful site activation
Perform recruitment of study sites, ensuring activities, documents and all other clinical data are accurately tracked and documented for project lifecycle
Clinical Specialist Jobs
By Planet Pharma At United States
Drive program adoption through ongoing clinician education, optimizing workflow, and delivering tangible results
2-5 years’ experience in the acute care healthcare setting
1-3 years’ medical device experience
Service, supply chain, or clinical experience perferred
MUST BE LOCATED IN CALIFORNIA, DENVER, CHICAGO, NYC, OR BOSTON
Engage hospital staff in customer business reviews, leveraging sustainability reports, savings metrics, and tracking to goals defined by the account
Clinical Study Manager Jobs
By Lexitas Pharma Services At United States
Must have excellent management and communication skills (written and verbal), strong problem-solving skills, and be detail oriented
Manages vendors, including the implementation and coordination of vendor’s Scope of Work (SOW).
Manages study budget and timelines. Identifies, resolves, or escalates issues involving study timelines and deliverables
Relevant experience as a CRA preferred
Study planning and set-up, maintenance, and close-out experience.
Must have a solid understanding of clinical research operations including GCP and regulatory requirements and operational procedures
Part-Time Contract Clinical Study Coordinator
By NeuroPace At San Francisco Bay Area, United States
General understanding of clinical documentation management and document control
Manage the eTMF (Trial Master File) system
Minimum of 2 years relevant work experience
Medidata and eTMF experience preferred
Previous experience in a clinical or regulatory department highly preferred.
Proficient in MS Word, Excel and Adobe PDF. Experience with clinical trial software systems, including eTMF, preferable
Clinical Study Manager Ii
By Tech Observer At New Jersey, United States
Assist the team with filing and data entry as appropriate
Demonstrates ability to manage all points of the clinical study project
Supports and effectively multi-tasks different and complex assignments and responsibilities.
Strong oral and written communication skills.
Investigates and determines solutions to difficult, problematic situations; escalates issues as necessary.
A Bachelor's degree in Life Sciences is acceptable.
Study Start- Up Specialist
By DOCS At All, MO, United States
Act as a back-up contact for the RA-CTA management
Participate in kick-off meetings and trial TCs with the EU Submission Hub and cluster Start-up Trial Managers
Provide input to submission timelines to EU Submission Hub and cluster Start-up Trial Manager
Prepare and handover to EU Submission Hub the annual trial report based on an input provided by cluster Trial Manager
Cooperate and communicate to EU Submission Hub and cluster Start-up Trial Manager progress and critical issues that may impair trial progress
Minimum 1 year of experience in start-up from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO)
Clinical Study Coordinator (Remote)
By Guardant Health At Palo Alto, CA, United States
Facilitate the coordination and management of clinical studies
Knowledge of ICH/GCP guidelines, including basic understanding of regulatory requirements in other countries, preferred
A minimum of 1 year experience in a CLIA, CAP-accredited laboratory preferred
A minimum of 1 year of experience as a clinical research coordinator preferred, ideally in a lab or device setting
Working knowledge of local, state, and federal laboratory regulations
Effective interpersonal skills and ability to effectively communicate (verbal and written) across all levels of the company
Clinical Specialist Jobs
By MedImpact Healthcare Systems At , Tempe, 85284, Az
Provide in-service education to PACs regarding topics such as PA guidelines, diagnoses commonly seen as part of the PA review process
Two (2) to five (5+) years related experience
Remote – Tempe, AZ or San Diego, CA
This job has no supervisory responsibilities.
To perform this job successfully, an individual should have knowledge of Microsoft Office Suite Word Processing software.
Responsible for providing clinical review support services to client plan(s) contracting for clinical services
Study Start-Up Specialist Jobs
By DOCS At All, MO, United States
Prepare and submit regulatory and IRB/IEC documentation as required per country requirements 
Strong written and verbal English communication skills
Demonstrated organization skills and attention to detail
Ability to work independently and manage multiple tasks and priorities
Preparation, tracking, and distribution of site start up documentation including Investigator Site File
Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met
Clinical Specialist Jobs
By Outset Medical, Inc. At Greater Tampa Bay Area, United States
Outset also offers the following benefits:
Effectively work cross-functionally with Outset Team members to deliver an exceptional customer experience.
Manage administrative tasks; reporting of dialysis treatments, training information and treatment growth outcomes in assigned region.
2 years of clinical experience, ideally in Dialysis
2 years medical device, biotech or pharmaceutical experience preferred
Excellent interpersonal skills with the ability to persuade decision makers
Clinical Specialist Jobs
By Mainstay Medical At , Orlando, Fl $95,000 - $110,000 a year
Collaborates with Therapy Manager on territory to help drive strategy and growth.
1-3 years work experience in healthcare and life sciences.
Bachelors degree or equivalent qualifications preferred.
Provides training and resources for hospital staff to enable them to conduct training (“train the trainer”).
Serves as effective Mainstay representative to physicians and support staff regarding Mainstay products, service, and support.
Advises physicians involved in setting up or evaluating Mainstay operations in their hospitals or clinics.
Project Coordinator I (Clinical Study Associate)
By Labcorp At , Wilmington, 19805, De $25.75 - $35.00 an hour
Targeted skill development and/or growth of knowledge base.
Knowledge in global/regional regulatory and compliance requirements for clinical research.
Demonstrated excellence in task management and cross-functional collaboration.
Collaborate with Clinical Operations Manager, study teams, and Clinical Research Organizations
Perform developmental tasks as appropriate with oversight of CTA Manager.
Supporting additional ad-hoc activities as needed, as agreed with CTA Manager.
Clinical Study Coordinator - Plymouth, Ma
By Lightship At Plymouth, MA, United States
Required knowledge, skills, and abilities
Supporting supply and inventory management, including:
Updating the inventory management system
Bachelor's Degree in Life Science or healthcare-related field, or requisite combination of education, training, and experience
Understanding and complying with all regulations, policies, and guidelines applicable to clinical research, including GCP, FDA, and IRB requirements
Collecting study data and completing data entry / case report forms in various electronic systems and on paper
Clinical Specialist Jobs
By Outset Medical, Inc. At San Antonio, Texas Metropolitan Area, United States
Outset also offers the following benefits:
Effectively work cross-functionally with Outset Team members to deliver an exceptional customer experience.
Manage administrative tasks; reporting of dialysis treatments, training information and treatment growth outcomes in assigned region.
2 years of clinical experience, ideally in Dialysis
2 years medical device, biotech or pharmaceutical experience preferred
Excellent interpersonal skills with the ability to persuade decision makers
Clinical Research Study Assistant I - Radiology
By Washington University in St Louis At , St. Louis, 63110, Mo $16.66 - $24.17 an hour
Solid organizational and interpersonal skills.
For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/
Attends routine meetings and other meetings related to the clinical research; stays abreast of information and any changes to study protocol.
Up to 22 days of vacation, 10 recognized holidays, and sick time.
Competitive health insurance packages with priority appointments and lower copays/coinsurance.
Clinical Specialist Jobs
By Treace Medical Concepts, Inc. At Atlanta, GA, United States
Bachelor’s degree. Equivalent combination of education, training, experience, and certifications may be considered in lieu of degree
Plans, coordinates and executes product training for surgeons (didactic and cadaveric). Ensures proper selection and qualification of all trainees
Advancing medical learning is at our core.
Create true value – not through paper or gimmicks.
Have a sense of urgency to win every day.
Only surround yourself with high performers.
Clinical Study Manager Jobs
By ICON At , Remote
Supporting management of interactions with relevant line functions including data management, drug supply management, clinical development
Experience in proactive operational planning with effective contingency and risk mitigation plans
Development of specific sections of the protocol and related documents Development of study tools, guidelines and training materials
Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries)
Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards.
Clinical Specialist Jobs
By Outset Medical, Inc. At Dallas-Fort Worth Metroplex, United States
Outset also offers the following benefits:
Effectively work cross-functionally with Outset Team members to deliver an exceptional customer experience.
Manage administrative tasks; reporting of dialysis treatments, training information and treatment growth outcomes in assigned region.
2 years of clinical experience, ideally in Dialysis
2 years medical device, biotech or pharmaceutical experience preferred
Excellent interpersonal skills with the ability to persuade decision makers
Clinical Specialist Jobs
By Cone Health At Greensboro, NC, United States

This position is responsible for providing quality Respiratory Care for patients, including neonates, pediatrics, adolescents, adults and geriatrics. Employees may be required to cover shifts at any ...

Clinical Study Coordinator Jobs
By Redbock - an NES Fircroft company At Dallas-Fort Worth Metroplex, United States
* Excellent written, verbal and interpersonal communication skills
* Strong organizational skills and attention to detail
* Proficiency in Spanish, phase II and/or phase III trial experience is a plus, but not required
* Communications and collaboration with patients, CROs, sponsors, PI(s) and internal teams, including participating in related meetings
* Support patient recruitment, ICF and CSR completion, protocol compliance, etc.
* Supply and equipment oversight

Are you looking for an exciting opportunity to join a dynamic team of clinical research professionals? We are seeking a Clinical Study Specialist to join our team and help us advance our mission of improving patient care through clinical research. As a Clinical Study Specialist, you will be responsible for managing clinical studies, ensuring compliance with regulatory requirements, and providing support to clinical investigators. If you are passionate about clinical research and have the skills and experience necessary to succeed in this role, we want to hear from you!

Overview A Clinical Study Specialist is a healthcare professional who is responsible for the planning, implementation, and management of clinical studies. They work closely with clinical research teams to ensure that all aspects of the study are conducted in accordance with applicable regulations and protocols. Clinical Study Specialists are responsible for the coordination of all activities related to the study, including the recruitment of participants, data collection, and analysis. Detailed Job Description Clinical Study Specialists are responsible for the planning, implementation, and management of clinical studies. They work closely with clinical research teams to ensure that all aspects of the study are conducted in accordance with applicable regulations and protocols. Clinical Study Specialists are responsible for the coordination of all activities related to the study, including the recruitment of participants, data collection, and analysis. They are also responsible for the preparation of study documents, such as protocols, informed consent forms, and study reports. In addition, Clinical Study Specialists are responsible for the training of research staff, the monitoring of study progress, and the management of study budgets. Job Skills Required
• Knowledge of clinical research regulations and protocols
• Excellent organizational and communication skills
• Ability to work independently and as part of a team
• Ability to manage multiple tasks and prioritize effectively
• Proficiency in Microsoft Office Suite
• Knowledge of medical terminology
Job Qualifications
• Bachelor’s degree in a related field
• At least two years of experience in clinical research
• Certification in clinical research (e.g. CCRA, CCRP)
Job Knowledge
• Knowledge of clinical research regulations and protocols
• Knowledge of medical terminology
• Knowledge of data collection and analysis methods
• Knowledge of study design and implementation
Job Experience
• At least two years of experience in clinical research
• Experience in the preparation of study documents
• Experience in the training of research staff
• Experience in the monitoring of study progress
• Experience in the management of study budgets
Job Responsibilities
• Plan, implement, and manage clinical studies
• Ensure that all aspects of the study are conducted in accordance with applicable regulations and protocols
• Coordinate all activities related to the study, including the recruitment of participants, data collection, and analysis
• Prepare study documents, such as protocols, informed consent forms, and study reports
• Train research staff
• Monitor study progress
• Manage study budgets