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 Coordinator Ii Jobs
By DLH Corporation At Durham, NC, United States
Assist with data collection, electronic data entry and audit checks.
Ability to multi-task and manage time effectively
Ability to pivot to meet changing requirements as needed
Experience drafting regulatory submissions for IRB
Experience with protocol development and consent writing
Experience working at a clinical research site and/or conducting federal clinical research
Study Coordinator Jobs
By DLH Corporation At Bethesda, MD, United States
Experience with adverse event reporting per clinical standards and FDA requirements strongly preferred
Work with Data Managers and Data Team members for forms preparation, and completion of adjudication procedures
Experience working in an academic or NIH research environment preferred
Knowledge of medical terminology preferred
Bachelor's degree req'd with 2 years experience in public health, clinical research or related field.
Implement study activities in accordance with NIH and FDA regulations
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
Research Study Coordinator, Infectious Diseases
By Northwestern University At Chicago, IL, United States
Skill/ability in laboratory management including database management, repository management, inventory/ordering, budgetary management, and working with external companies.
Preferred Competencies: (Skills, knowledge, and abilities)
Educational certification beyond a bachelor’s degree.
Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols.
May act as a mentor in regard to education of junior coordinators.
Two years’ clinical lab experience, preferably in an infectious disease or clinical microbiology laboratory setting.
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
Study Coordinator Jobs
By McKesson At Nashville, TN, United States
You will present in weekly protocol meeting to investigators, research staff, and management
You will maintain case report forms tracking management database
You will reports patient visit and data entry information in financial tracking system.
Knowledge of FDA guidelines and GCP is required.
Interpersonal skills, detailed-oriented and meticulous.
Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel
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.
Research Study Coordinator -Psychometry (Contract / Part-Time)
By BrainCheck At Austin, TX, United States
Education/Experience: - Education, coursework, or degree in a related discipline, or equivalent combination of education and experience
Assist in general research study etiquette ensuring adherence to protocol, GCP, HIPAA, and regulatory requirements
Experience conducting human subjects research, data collection, and working with individuals in a professional setting
Detail-oriented multitasker with exceptional organization and the ability to effectively manage yourself
Lead and coordinate recruitment and scheduling of participants
Conduct study procedures with participants including administering neuropsychologist tests, collecting informed consent, and completing questionnaires
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
Research Study Coordinator (Fixed Duration/Temporary)
By University of Washington At , Seattle, 98195, Wa $3,260 - $4,239 a month
Assist in preparation of manuscripts for publication using current American Psychological Association style requirements.
Manage inventory, order supplies, print advertising and study materials, and maintain up-to-date budget documentation with oversight.
one year duration full time research study coordinator
Work as a part of an active and collegial investigative team, demonstrating clear, collegial, and professional communication.
Assist in modifying data collection materials forms using Qualtrics or other online collection platforms.
Assist key personnel to complete reports to various regulatory agencies.
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.
Coordinator, State Awards Program ( Federal Work Study Coordinator)
By Georgia State University At Atlanta Metropolitan Area, United States
A flexible work environment - this position is eligible for two remote days per week.
Generous benefits, including health, dental, vision, tuition assistance, retirement, etc.
A knowledge-sharing organization that works collaboratively with diverse staff.
Professional development opportunity and mentorship
A rapidly growing center within an academic setting
Commitment to diversity, equity, and inclusion
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
Freelance Clinical Study Manager (Usa) - Remote - Pharma
By MSI Pharma At United States
Global studies to manage in Oncology (you will be responsible for 1-2 studies across Phase II&III)
(Remote in USA) - Pharma sponsor, Oncology
Responsible for managing the clinical monitoring process and the administration of clinical trials.
Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration.
Oversees adherence to SOPs, Good Clinical Practice and regulations
(you will be responsible for 1-2 studies across Phase II&III)

Are you looking for an exciting opportunity to be part of a dynamic clinical research team? We are seeking a Clinical Study Coordinator to join our team and help us make a difference in the lives of patients. As a Clinical Study Coordinator, you will be responsible for managing clinical studies from start to finish, ensuring that all study protocols are followed and that data is collected and reported accurately. If you are a detail-oriented individual with excellent organizational skills, this could be the perfect job for you!

Overview Clinical Study Coordinators are responsible for managing the day-to-day operations of clinical research studies. They are responsible for ensuring that all study protocols are followed, that data is collected accurately, and that the study is conducted in compliance with all applicable regulations. Detailed Job Description Clinical Study Coordinators are responsible for the overall management of clinical research studies. This includes developing and implementing study protocols, recruiting and enrolling study participants, collecting and managing study data, and ensuring that all study activities are conducted in compliance with applicable regulations. Clinical Study Coordinators also provide support to the study team, including physicians, nurses, and other healthcare professionals. Job Skills Required
• Strong organizational and communication skills
• Knowledge of clinical research protocols and regulations
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office and other computer applications
• Ability to manage multiple tasks and prioritize work
• Attention to detail
Job Qualifications
• Bachelor’s degree in a related field
• Previous experience in clinical research or healthcare
• Certification in clinical research (e.g., CCRC, CCRP, etc.)
Job Knowledge
• Knowledge of clinical research protocols and regulations
• Knowledge of Good Clinical Practice (GCP)
• Knowledge of medical terminology
• Knowledge of data management systems
Job Experience
• Previous experience in clinical research or healthcare
• Experience in data collection and management
• Experience in recruiting and enrolling study participants
Job Responsibilities
• Develop and implement study protocols
• Recruit and enroll study participants
• Collect and manage study data
• Ensure compliance with applicable regulations
• Provide support to the study team
• Monitor study progress and report any issues
• Prepare study reports and presentations