Clinical Trial Associate Job Description
Clinical trial associate
provides leadership and coaching to Regional Clinical Research Associates ensuring day-to-day monitoring activities and implementation of processes are in compliance with ICH-GCP, Canadian regulatory requirements, Novo Nordisk SOPs and Clinical Development Guidelines.
Clinical Trial Associate Duties & Responsibilities
To write an effective clinical trial associate job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical trial associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Create files
Obtain from internal and external stakeholders essential documents
Prepare inventory lists of study files in prior eTMF system
Import essential documents to current file locations
Conduct eTMF reviews to identify gaps and obtain missing documents
Complete study checklists that reflect content of study eTMFs
Archive hard copy essential documents to storage facility
Support CDA/NDA activity
Assist with vendor invoicing
Manage study and group trackers
Clinical Trial Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Trial Associate
List any licenses or certifications required by the position: CCRP, CCRC, CCRA, APICS
Education for Clinical Trial Associate
Typically a job would require a certain level of education.
Employers hiring for the clinical trial associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Health, Life Sciences, Education, Healthcare, Nursing, Life Science, Medical, Pharmacy, Associates
Skills for Clinical Trial Associate
Desired skills for clinical trial associate include:
Excel
MS Word
PowerPoint
Drug development process
ICH/GCP and regulatory guidelines/directives
Databases
PowerPoint and Outlook
Medical/scientific terminology
Regulatory requirements and guidelines governing clinical research
ICH
Desired experience for clinical trial associate includes:
Assist managers in meeting material and logistic preparation
Ensure compliance due dates are defined and timelines for registration are met
Collaborate with Study Teams to compile data for Clinical Trial Protocol/Results for new, ongoing and completed studies
Provide operational support to ensure the alignment of posted information across all registries
Ensure consistency of information throughout all trial disclosures portals
Prepare inspection-readiness checklists and support internal and external audit requirements
Clinical Trial Associate Examples
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Clinical Trial Associate Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical trial associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical trial associate
- Raise alerts where current status of data quality or performance is at risk to achieving business goals
- Serve as lead on IT projects around automation of reports or development of tools to aid/ drive process improvement as appropriate
- Support related systems as acting subject matter expert to SharePoint, Metrixx, Vantage, Compass, IMPACT, iDASH
- Oversee quality control of reports/tools functionality
- Provide support to both the Field Monitoring and Project Management Organizations
- Support ClinAdmin data entry and maintenance of country, site and patient visit level data as needed
- Identifying and ensuring strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical studies under his/her responsibilities
- Managing all activities of assigned clinical studies within the Clinical R&D Operations group
- Functioning as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- Evaluating support requests for publications and to provide consolidated comments and support to the requests
Qualifications for clinical trial associate
- Managing Resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
- Tracking assigned projects budgets to ensure adherence to business plans
- Supporting the implementation of new clinical systems/processes, and provide support for publications, as needed
- Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
- Providing quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies
- Assist with ensuring sponsored project and fellowship proposals and awards are complete, contain accurate budgets, and meet university compliance
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Clinical Trial Associate Job Description
Job Description Example
Our company is searching for experienced candidates for the position of clinical trial associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical trial associate
- Basic understanding of applicable federal regulations, sponsor requirements, and University policies such as OMB A-21, OMB A-110, Cost Accounting Standards, Food and Drug Administration and Medicare pricing and reimbursements
- Conduct a preliminary review of sponsor awards for consistency with proposal request
- Provide administrative support to the CTRPM on progress and final reports
- Work with University and School of Medicine central offices to facilitate the pre- and post-award processes
- Working knowledge of University systems such as SeRA, eProtocol, Oncore
- Assist CTRPM with data collection and data integrity in the SeRA system
- Supports Clinical Biometrics in coordination of receipt of all ancillary data safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock
- Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines
- Acting as Global Regulatory Leader for designated clinical trials in liaison with internal and external partners
- Development of global submission strategies for clinical trials
Qualifications for clinical trial associate
- Able to communicate ideas and concepts clearly in both written and oral form
- Frequently perform desk based computer tasks, seated work, use a telephone and use light/ fine grasping
- Occasionally write by hand, lift, carry, push pull objects that weigh up to 10 pounds
- Rarely stand, walk, sort, and file paperwork or parts
- Contacting external and internal individuals
- You will possess sufficient administrative experience within a busy environment where you have demonstrated excellent organisation and prioritization skills or hold a bachelor’s degree in a science related field
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Clinical Trial Associate Job Description
Job Description Example
Our innovative and growing company is looking for a clinical trial associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical trial associate
- Provide technical oversight of the compilation, review and release of applications for clinical trials in compliance with regulatory requirements internal guidelines
- Conduct reviews of key technical study documents to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents and ease of review
- Design and complete regulatory deliverables for designated projects
- Provide regulatory advice to project teams
- Manage life-cycle of designated studies post approval
- Keeping up-to-date with regulatory requirements
- Provide modeling and CTS supports to clinical trial design, drug development planning, licensing candidates evaluation, and critical post-marketing commitments to guide decision making
- Provide modeling and CTS support for regulatory filings and/or in response to regulatory requests
- Closely collaborate with project teams consisting of members of different functions
- Perform related modeling and clinical trial simulations, in addition to any required methodology research
Qualifications for clinical trial associate
- Minimum 0-2 year's experience in relevant field (eg
- Demonstrated ability to meet long and short-term deadlines with accuracy
- You will be fluent in English and the local language for the country you are applying
- Fluency in English is a must (any additional European languages are a plus)
- Minimum of a Bachelor's Degree in Life Sciences or Pharmacy, Advanced Degree Preferred
- At least fluent vocal and written English and Romanian
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Clinical Trial Associate Job Description
Job Description Example
Our company is looking for a clinical trial associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical trial associate
- Reviews study start up documents and disseminates to the appropriate functional groups
- Maintains study specific timelines, and provides information as needed to the study team
- Escalates non-standard problems or issues as may be required
- Preparing essential clinical trial documentation, distributing, tracking and filing of documents
- Identifies potential issues and suggests resolutions
- Maintains ongoing contact and communication with the clinical teams
- Prepares CTA submission to Health Canada and France
- To prepare and coordinate of regulatory deliverables for assigned projects in Canada and France, including close cooperation with regulatory authorities
- To act as local regulatory contact and regulatory lead for assigned studies (France)
- You may act as a Regulatory Project Lead on small clinical research projects
Qualifications for clinical trial associate
- PhD in quantitative sciences including statistics, biostatistics, engineering, mathematics, computational science, or a field with significant modeling-related content is preferred
- 4+ years of experiences in pharmaceutical industry and clinical trial knowledge are preferred
- A degree in Life Sciences
- Regulatory experience with Clinical Trials
- Previous experience in Regulatory Affairs and Clinical Research
- Experience in clinical study start-up
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Clinical Trial Associate Job Description
Job Description Example
Our growing company is looking for a clinical trial associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical trial associate
- Register and maintain trial information on public websites
- Customize/update any portfolio level plans or process flows to the study/ site level in collaboration with the CPLs and the CRO teams, as appropriate such TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release documentation collection plan
- Serve as a system expert for the implementation of any business technologies that are operational in a study/franchise throughout the study’s life cycle
- Generate and maintain study essential documents checklist, IP release documentation and proactively ensure study document submission to the eTMF throughout the study’s life cycle
- Coordinate study team training in the investigator portal
- Deliver CRA training at KOM on business technologies/applications that are operational in a study
- Responsible for ensuring registration of a protocol in ClinTrials.gov and monitor its update throughout a study’s life cycle for compliance with the regulations and SOP
- Participate in sponsor operational team meetings with the CRO, Data Management, Regulatory Affairs, CQA and Clinical Supplies and document escalations and actions around training, TMF, IP release Clinical Trial Registry documentation
- Participate as a SME in the implementation of various Clinical Operations initiatives in conjunction with the CoE as required
- Monitors the status of start-up timelines for new studies including IRB approval and contract execution
Qualifications for clinical trial associate
- She/he has worked already in an international environment or CRO
- Minimum of a Bachelor's Degree in Life Sciences or Pharmacy, Advanced Degree strongly preferred
- 3-5 years of experience in Regulatory Affairs and Clinical Research
- Bachelor’s degree and 5-7 years relevant industry
- Fluency in English is a must along with the local language
- Problem solving abilities, troubleshooting and resourcefulness