Clinical Trial Assistant Job Description
Clinical Trial Assistant Duties & Responsibilities
To write an effective clinical trial assistant job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical trial assistant job description templates that you can modify and use.
Sample responsibilities for this position include:
Clinical Trial Assistant Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Trial Assistant
List any licenses or certifications required by the position: CCRP
Education for Clinical Trial Assistant
Typically a job would require a certain level of education.
Employers hiring for the clinical trial assistant job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Communication, English, Medical, Life Sciences, Education, Life Science, Finance, Business, Health
Skills for Clinical Trial Assistant
Desired skills for clinical trial assistant include:
Desired experience for clinical trial assistant includes:
Clinical Trial Assistant Examples
Clinical Trial Assistant Job Description
- Preparation of document/spreadsheets for data reviews
- May include site and vendor interaction
- Provide technical support by tracking and reporting of trial budgets, invoices, and related financial documentation activities
- Create and maintain vendor contact lists other internal lists
- Coordinates and provides technical oversight for both internal/external meetings
- You will have between 12 to 15 direct reports
- Organize and maintain project working files and track critical documents
- Essential Functions required for the job
- Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Assist in creating, assembling and coordinating shipping of study materials
- Excellent demonstrable verbal and written communication skills
- Able to work within a team with a service oriented approach
- Able to perform routine assignments with general instructions and new assignments with detailed instructions
- BA, BS, AA or AS degree in life sciences, nursing or related disciplines
- Bachelors degree in an administrative discipline or equivalent experience
- Fluent English and Lithuanian
Clinical Trial Assistant Job Description
- Effectively uses available tools and systems to gather information needed to manage study activities and to provide feedback to the appropriate team members
- All administration and preparation work for trial site set-up and related tracking activities
- Help and support the Country Approval Specialists, CRAs and Contract Specialists with administrative tasks
- Preparation of submission packages
- Set-up and maintenance of project files and documentation according to Standard Operating Procedures and Working Practices
- You will need to ensure high levels of accuracy, to manage and maintain clinical study documentation
- Contact external and internal individuals
- Track and reconcile essential documents for Central Master Files according to ICH GCP and/or ISO 14155 and company procedures
- Work within established SOPs
- Prepare and compile study related materials including investigator meeting binders, training manuals, Site regulatory binder, Site study binders
- Ability to mentor and train new Project Assistants as needed
- Excellent English & Danish language skills
- Act as a central contact for the team for assigned project communications, correspondence and associated documentation
- Support the preparation, handling, distribution, filing, and archiving of clinical documentation and reports
- You will need to ensure high levels of accuracy when completing tasks, you will set up, manage and maintain clinical study documentation and coordinate the ordering, dispatch and tracking of study materials
- You will arrange and attend internal and external meetings, helping to produce presentation materials and generate meeting minutes
Clinical Trial Assistant Job Description
- Support study feasibility activities and perform database/web searches for sites as needed
- Track and assist with processing site/vendor payments
- Participate in testing of specifications and edit checks for internal
- Assist with the preparation and distribution of meeting agendas and minutes
- Support and correspond with sites to identify site specific needs
- May deliver training related to day-to-day responsibilities for new CTA and CTM hires within department
- May provide administrative support to manager/group as assigned
- Prepare and oversee expense account reporting
- Schedule and coordinate new hire candidate interviews
- Leading broad and/or cross-functional projects for the Clinical Operations team and managing project timelines and deliverables
- Responsible for reconciliation of monthly invoices/PO management
- Participate in review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports
- A BSN
- Minimum Diploma or STPM/SPM or equivalent with at least 2-3 years experience in administration
- Actively enrolled college/university student, sophomore year student preferred
- Ideal candidate would be a self-starter with the ability to work independently and meet timelines
Clinical Trial Assistant Job Description
- Performing other related activities as assigned
- Coordinate patient study visits and procedures
- Coordinate with the investigator, the scheduling, preparation and provision of education and information regarding clinical protocol s to associated health care personnel and study subjects
- Collect and maintain a file of regulatory documents, study documentation and communication for each study
- Obtain informed consent from potential study candidates
- Consistently track and update subject participation in database
- Candidate with 2-4 yrs
- Provide day-to-day departmental/project support activities, such as managing study supply inventory and orders, shipping, filing, faxing
- Maintain databases/spreadsheets and compile reports
- Sets up files related to a variety of clinical trials
- Team player with excellent customer focus
- Must be available to work a minimum of 12 week, full time
- Self-starter and fast learner, with the ability to work independently collaboratively
- Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements preferred
- Excellent communication, writing, organizational skills , attention to detail, time-management skills, strong work-ethic, self-motivated, willing to learn
- Ability to effectively interact with the study team, study sponsors, the Research Institute, and the IRB to accomplish goals in a timely manner
Clinical Trial Assistant Job Description
- Knowledge in various processes and systems to fully support the protocol teams and clinical trial processes
- Maintain, verify, process, and makes updates to PFE systems (including Registry), spreadsheets / documents as needed
- Generate reports from PFE systems (CAL, RT2) as directed to support completion of and tracking of submission deliverables
- Coordinates ordering and tracking of trial supplies
- Complete Process Data Collection Forms
- Provides general support to the Clinical Operations team on other clinical trial related duties and tasks, as required
- To handle all study related administrative tasks by utilizing technology effectively to support the clinical trial development processes with the use of Clinical Trial Management System at the Protocol, Country and Site level
- Coordinating archiving of study documents
- Answers and resolves routine questions independently
- Partners with the study team to ensure overall study management and adherence to internal SOPs, policies, local regulatory requirements and department processes
- High school Diploma or Bachelors degree in Life Science preferred
- Bachelor’s degree in life sciences, scientific or other relevant discipline and 2 – 4 years of relevant experience in the health care, biotechnology or diagnostics industry
- High school diploma or Associate’s Degree and 3 – 5 years of related experience in the health care, biotechnology or diagnostics industry
- Demonstrated competency in the utilization of Microsoft tools, specifically Word
- Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus
- People Relationships