ทักษะ:

Microsoft Office, English

ประเภทงาน:

งานประจำ

• Standard (Mon-Fri).
• Environmental Conditions.
• Office.
• The CRA Level I performs and coordinates different aspects of the clinical monitoring and site management process. The role conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
• The CRA manages procedures and guidelines across different sponsors and/or monitoring environments, including FSO, FSP, and Government environments. The CRA acts as a site processes specialist, ensuring clinical trials are conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, with the objective of protecting subjects' rights and well-being and ensuring data reliability and audit readiness. The role also develops collaborative relationships with investigational sites.
• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving to identify process failures and implement corrective/preventive actions.
• Ensure data accuracy through SDR, SDV, and CRF review, as applicable, through on-site and remote monitoring.
• Assess investigational product through physical inventory and records review.
• Document monitoring observations in reports and letters and promptly escalate deficiencies or issues to clinical management, following them through resolution.
• Maintain contact with investigational sites between monitoring visits to confirm protocol adherence, resolution of previously identified issues, and timely data recording.
• Conduct monitoring activities according to the approved monitoring plan.
• Participate in investigator payment processes and collaborate with project team members on issue/finding resolution.
• Participate in investigator meetings and potentially assist with identifying qualified investigators/sites.
• Initiate clinical trial sites according to applicable procedures and ensure compliance with protocol, regulatory, and ICH-GCP obligations.
• Perform trial close-out activities and retrieval of trial materials.
• Ensure required essential documents are complete and available according to ICH-GCP and applicable regulations, including conducting on-site file reviews.
• Provide trial status tracking and progress reports.
• Ensure study systems, including Clinical Trial Management Systems (CTMS), are complete, accurate, and up to date.
• Facilitate effective communication among investigative sites, clients, and internal project teams.
• Respond to company, client, and applicable regulatory requirements, audits, and inspections.
• Complete administrative tasks such as expense reports and timesheets.
• Assist the project team in preparing project publications/tools and contribute ideas and suggestions.
• Participate in project work and process-improvement initiatives.
• Travel extensively; the document specifies a travel requirement higher than 75%, while the working-conditions section describes travel as generally 60-80%, potentially more for some individuals.
• Education & Experience.
• Education.
• Bachelor's degree in a life sciences-related field.
• Experience.
• Minimal clinical monitoring experience sufficient to perform the role, described as comparable to approximately 2 years.
• Relevant experience may come from clinical trials, medical terminology, medical research, clinical research, healthcare, or a health sciences field with formal training in medical terminology and anatomy.
• Valid driver's license where applicable.
• An appropriate combination of education, training, and directly related experience may be accepted as an equivalent qualification.
• Knowledge, Skills & Abilities.
• Basic medical/therapeutic-area knowledge and understanding of medical terminology.
• Ability to attain and maintain working knowledge of ICH-GCP, applicable regulations, and procedural documents.
• Good oral and written communication skills, including communication with medical personnel.
• Good interpersonal skills.
• Customer focus, listening skills, attention to detail, and ability to identify underlying customer issues.
• Good organizational and time-management skills.
• Flexibility and adaptability across different situations.
• Well-developed critical thinking, investigation, root cause analysis, and problem-solving skills.
• Ability to manage Risk-Based Monitoring (RBM) concepts and processes.
• Ability to work independently or as part of a team.
• Good computer skills, including solid Microsoft Office knowledge and ability to learn relevant software.
• Good English language and grammar skills.

ทักษะ:

Problem Solving, Recruitment, English

ประเภทงาน:

งานประจำ

• Completes study and site management activities as defined in task matrix, andas applicable and directed for study assigned.
• Completes and documents study-specific training.
• Orients and trains on any study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
• Supports to customize Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
• Verifies document collection and RCR submission status; updates site EDL and verifies site information.
• Reviews patient facing materials and review translations, as directed.
• Supports site staff with the vendor related qualification process, where applicable.
• Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
• Provides support to follow-up on site staff training, as applicable.
• Coordinates and supports logistics for IM attendance, as directed.
• Supports maintenance of vendor trackers, as directed.
• Coordinates study/site supply management during pre-activation and subsequentcourse of the study.
• Supports Essential Document collection, review and updating in systems, as applicable.
• Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
• Supports ongoing remote review of centralized monitoring tools, as directed.
• Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period.
• Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
• Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed.
• May perform other assigned site management tasks, as directed by CRA and as per Task Matrix.
• May perform a specific role profile for FSP opportunities according to Client requests.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Education and Experience.
• Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents.
• Effective oral and written communication skills.
• Excellent interpersonal and customer service skills.
• Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Proven flexibility and adaptability.
• Ability to work in a team or independently, as required.
• Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable.
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards.
• Excellent English language and grammar skills.
• Work is performed most of the time in an office or home office environment.; occasional travel toclinics/hospitals may be required.
• Exposure to electrical office equipment.
• The Assistant CRA role does not involve regular travel, however, any direct, promotional opportunities in the CRA career track will require frequent travel (60-80%).

ประสบการณ์:

6 ปีขึ้นไป

ทักษะ:

Business Development, Project Management, Microsoft Office, Market Analysis, Salesforce, English

ประเภทงาน:

งานประจำ

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in business development or commercial experience in scientific/technical industries.
• Preferred Fields of Study: Engineering, Chemistry, Life Sciences, Business Administration or related field.
• Professional certifications in project management or relevant technical fields advantageous.
• Demonstrated success in developing and executing strategic business plans and meeting revenue targets.
• Effective team leadership experience with cross-functional teams and channel partners.
• Strong relationship management skills across all organizational levels.
• Experience in complex negotiations and completing high-value agreements.
• Deep understanding of customer workflows and industry trends in relevant market segments.
• Strong analytical and financial acumen for market analysis and opportunity assessment.
• Excellence in presentation, communication, and interpersonal skills.
• Proficiency with CRM systems (e.g., Salesforce) and Microsoft Office suite.
• Ability to travel up to 25-30% as needed.
• Fluency in English required; additional language skills valuable.
• Experience with regulatory compliance and quality standards in relevant industries.
• Strong project management capabilities and attention to detail.
• Ability to work independently while collaborating effectively in a matrix organization.

ประสบการณ์:

2 ปีขึ้นไป

ทักษะ:

Microsoft Office, Electronics, GMP, English

ประเภทงาน:

งานประจำ

• Advanced Degree, no prior experience required, or Bachelor's Degree plus 2 years of hands-on technical experience installing, troubleshooting and repairing complex analytical instruments.
• Preferred Fields of Study: Electronics, Engineering, Physics, Chemistry, or related technical field.
• Additional relevant certifications are advantageous.
• Strong electronics and mechanical troubleshooting skills with ability to diagnose issues down to component level.
• Experience with ultra-high vacuum systems and high voltage equipment preferred.
• Excellent customer service and communication skills, both written and verbal.
• Strong organizational and time management capabilities.
• Proficiency with Microsoft Office suite and service management software.
• Ability to read and interpret technical documentation and schematics.
• Valid driver's license and ability to travel up to 50-75% within assigned territory.
• Physical ability to lift up to 50 lbs and work in various laboratory environments.
• Proficiency in English required; additional languages beneficial.
• Strong problem-solving abilities and capacity to work independently.
• Adherence to safety protocols and quality standards.
• Ability to respond to customer needs with short notice.
• Ability to effectively train and support customers on equipment operation.
• Experience documenting service activities and preparing detailed reports.
• Demonstrated success in meeting customer satisfaction goals.