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Clinical Study Associate I Jobs

Clinical Study Manager - Ivd/Medtech - Remote
By NAMSA At United States
Act with integrity in everything we do.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Come and work for an organization with the:
Clinical Study Assistant Jobs
By Kelly Science, Engineering, Technology & Telecom At Irvine, CA, United States
Run reports including training matrix reports, metrics for management reviews
Support management of IRB/IEC renewal compliance.
Work with management group to help achieve department goals.
Requires experience and knowledge working with computer systems (Microsoft office –
Assist in payments/tracking for patient reimbursements. Performs data entry in systems
Is responsible for ensuring appropriate level of communication with managers, project leaders, and team members.
Clinical Study Manager, Clinical Operations
By Daiichi Sankyo, Inc. At United States
Note that vendor management is not limited to the CRO, but includes ancillary vendors (e.g. translations, trial insurance, and central laboratory).
Ensure DS internal tracking systems are updated (e.g. Global Project Management System, GPMS).
Education Qualifications (from An Accredited College Or University)
Associate degree or with a nursing diploma with substantial experience preferred.
4 or More Years relevant experience is required with a BS preferred.
Bachelor's Degree in the Sciences preferred.
Clinical Study Nurse Coordinator
By University of Nebraska Medical Center At , Omaha $66,000 - $99,000 a year
Required Additional Knowledge, Skills and Abilities:
Preferred Additional Knowledge, Skills and Abilities:
If any experience is required, please specify what kind of experience:
If yes, what is the required licensure/certification?
Nursing experience in oncology and/or clinical research.
If yes, what is the preferred licensure/certification?:
Clinical Office Associate I
By University of Alabama at Birmingham At , Birmingham
4. Organizes and manages general office tasks.
Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite
2. Handles confidential information such as employee personnel records and other literature or correspondence.
3. Initiates, prepares and processes administrative documents.
6. Perform other duties as assigned.
(Hourly Rate: $15.00 - $22.75)
Clinical Study Support - Icf
By ICON At , Remote
Bachelor’s Degree in business administration, finance, science or related field or equivalent experience.
Central Services Specialist - ICF Management
Co-manages maintenance of the centralized Informed Consent Form mailbox.
Minimum of three years of relevant experience in the biopharmaceutical/CRO industry.
Experience in negotiating vendor contracts/budgets.
Proven ability to effectively manage change.
Global Study Management Associate
By BeiGene At , Remote $61,500 - $86,500 a year
Establishes good collaboration with Global Clinical Study Manager, Regional Clinical Trial Management Associates and other key stakeholders globally and regionally
Builds solid knowledge of global clinical trials operations under guidance of the Global Clinical Study Manager
Prepares metrics and updates to key deliverables for management as per information available in relevant systems
Supports management of global study budget incl PO set-up
Project Management - Communicates changes and progress; Completes projects on time and within budget.
Supports the alignment of study goals with clinical operations goals and objectives under direction of the Global Clinical Study Manager
Clinical Study Support- Icf
By ICON Strategic Solutions At United States
Co-manages maintenance of the centralized Informed Consent Form mailbox.
Minimum of three years of relevant experience in the biopharmaceutical/CRO industry.
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
MUST CURRENTLY WORK AT A CRO/PHARMA
Reviews and validates quality and accuracy of Informed Consent Form templates.
Supports development of Informed Consent Form templates.
Associate Director Clinical Study Management
By BeiGene At United States
Management experience of CROs, Vendors and Consultants preferred
Ensures the competencies and skills required for the Clinical team is consistent with the company defined requirements
Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans
8+ years progressive experience in clinical operations preferably within the biotech, pharmaceutical, and/or CRO environment
Possess understanding of treatment landscape, standard of care, upcoming approvals, and good knowledge of KOLs and investigators
Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required
Clinical Study Coordinator - Chatham, Ny
By Lightship At Chatham, NY, 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
Study Support Coordinator I
By Clinical ink At United States
Support the organization with daily tasks including user management, site management, equipment requests, data entry and report generation
Provide support for front-end client activities across multiple clinical research studies
Work closely with clients to ensure all data required for study start-up is collected and maintained
Provide details and information to clients in response to inquiries regarding study support and set-up
Update project-related internal databases and electronic files to ensure accuracy
Assist with special department projects
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.
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
Associate Director - Study Abroad
By University of Central Florida At Greater Orlando, United States
Strong written and oral communication skills are key to this position.
Experience with Terra Dotta, Workday, and PeopleSoft is desirable.
Benefit packages, including Medical, Dental, Vision, Life Insurance, Flexible Spending, and Employee Assistance Program
And more…For more benefits information, to go to the UCF Employee Benefits page click here.
Are Benefits Important to You?
Supervises personnel, as assigned. Supervises grant-funded Peace Corps Strategic Recruiter.
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 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 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.

Are you looking for an exciting opportunity to join a dynamic team of Clinical Study Associates? We are looking for a Clinical Study Associate I to join our team and help us make a difference in the lives of patients. You will be responsible for coordinating and managing clinical studies, ensuring compliance with applicable regulations, and providing support to the clinical team. If you are a detail-oriented individual with excellent organizational and communication skills, this could be the perfect job for you!

Overview Clinical Study Associate I is a professional who is responsible for providing administrative and operational support to clinical research studies. They are responsible for ensuring that all study activities are conducted in accordance with applicable regulations and guidelines. They are also responsible for coordinating the collection and review of study data, and for providing support to the clinical research team. Detailed Job Description Clinical Study Associate I is responsible for providing administrative and operational support to clinical research studies. This includes coordinating the collection and review of study data, ensuring that all study activities are conducted in accordance with applicable regulations and guidelines, and providing support to the clinical research team. They are also responsible for maintaining accurate records of study data and for preparing reports and presentations for review by the clinical research team. Job Skills Required
• Excellent organizational and communication skills
• Knowledge of clinical research regulations and guidelines
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office applications
• Ability to manage multiple tasks and prioritize workload
• Attention to detail and accuracy
Job Qualifications
• Bachelor’s degree in a related field
• Previous experience in clinical research or related field
• Knowledge of Good Clinical Practice (GCP)
• Knowledge of applicable regulations and guidelines
• Ability to work in a fast-paced environment
Job Knowledge
• Knowledge of clinical research regulations and guidelines
• Knowledge of Good Clinical Practice (GCP)
• Knowledge of applicable regulations and guidelines
• Knowledge of clinical research processes and procedures
• Knowledge of data collection and analysis
Job Experience
• Previous experience in clinical research or related field
• Experience in data collection and analysis
• Experience in preparing reports and presentations
• Experience in coordinating clinical research activities
Job Responsibilities
• Coordinate the collection and review of study data
• Ensure that all study activities are conducted in accordance with applicable regulations and guidelines
• Maintain accurate records of study data
• Prepare reports and presentations for review by the clinical research team
• Provide administrative and operational support to clinical research studies
• Provide support to the clinical research team
• Monitor study progress and provide updates to the clinical research team