Clinical Trial Specialist Job Description
Clinical Trial Specialist Duties & Responsibilities
To write an effective clinical trial specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical trial specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Clinical Trial Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Trial Specialist
List any licenses or certifications required by the position: RAC, SOCRA, ACRP, CIM, CIP, RA, CRA
Education for Clinical Trial Specialist
Typically a job would require a certain level of education.
Employers hiring for the clinical trial specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Health, Education, Science, Nursing, Pharmacy, Biological Science, Life Science, Healthcare, Business, Technical
Skills for Clinical Trial Specialist
Desired skills for clinical trial specialist include:
Desired experience for clinical trial specialist includes:
Clinical Trial Specialist Examples
Clinical Trial Specialist Job Description
- Complete routine departmental administrative tasks in an accurate and timely manner
- Responsible for training, education, and mentoring Clinical Trial Specialists
- Initiate improvements, tools, processes, and forms to enhance the efficiency and the quality of work of Study Operations
- Leads the execution of highly complex clinical trials for the drug development unit
- Reviews source documentation and communicates responses from sponsor regarding patient eligibility with nursing staff and physicians
- Educates Research Nurses and clinic staff on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments
- Collects, completes and enters data into study-specific case report forms or electronic data capture systems within 10 days of patient visits
- Creates study specific tools for source documentation including eligibility worksheets, screening checklists and intense sampling worksheets capturing vitals, ECGs, blood and tumor sampling
- Responsible for following patients’ response to treatment according to RECIST criteria in real time to assist in treatment decisions
- Participates in monitor visits monthly for each trial assigned
- To review and negotiate all Regulatory documents for completeness
- To negotiate with Investigators, Research Nurses and Site staff where necessary
- Work with Clinical Research Associates to ensure essential documents are collected and submissions occur
- Bachelor’s degree in life science, health science or nursing
- Knowledge of applicable FDA guidelines and regulations in a pharmaceutical, clinical research or clinical setting would be a significant advantage
- Excellent communication skills and proven team player in multidisciplinary, international settings
Clinical Trial Specialist Job Description
- Monitors and maintains accurate and complete information concerning study cohort, slot allocation, toxicity and response on trial
- Responsible for reporting on dates of cohorts opening, number of slots allocated to SCRI other sites and dates of all patients starting treatment
- Timely and accurate completion of Serious Adverse Events (approximately 2 per week)
- Intense sponsor interaction including daily phones calls and e-mails to update on patient status toxicity and response
- Present data on weekly teleconferences with sponsors to update on patients including last visit, any toxicity, and response
- Assist Drug Development Program Sites as needed with trial specific needs including protocol assessment/eligibility issues and data entry questions (if applicable)
- Key point of contact for liaison with third party vendors
- Representing regulatory perspective in cross functional process improvement initiatives and cross therapy area department initiatives
- Inputting into key face to face study kick off teams and workshops to design and deliver regulatory strategies tailored for all countries involved & mitigate any potential issues which could impact development programme timelines
- Providing core information for country application forms for affiliates, author EU Clinical Trial Application forms, review CTA documents to ensure compliance with current requirements
- Knowledge of the principles and practices of computer applications in database management
- Open minded, motivated personality with focus on details
- Fluent verbal and written English, German of advantage
- Bachelor’s degree in a life science field with 2+ years of technical or preferably scientific writing experience
- Determine the appropriate submission strategy and consistency of the Clinical Trial Application (CTAp) across projects, studies and countries
- Effectively lead CTAp Tracking Meetings for the preparation of the CTAp dossier during start-up with cross-functional team and assure timelines and dossier quality are managed according to expectations
Clinical Trial Specialist Job Description
- Triaging and collating responses to questions from Competent Authorities and dictate compliance times
- Acting as primary interface to and from personnel in affiliates who interface with local agencies for clinical trials
- Participating in continuous improvement initiatives within CTRG and cross functionally
- Supporting internal and external inspections and cross functional process improvement initiatives
- Under supervision, regularly informing regulatory management of important timely issues and the impact on the global program
- Translate Clinical Development requirements into an actionable supply plan
- Assess issues with regards to study design, supply availability and timelines
- Determine distribution strategies
- Oversee identification, appropriate provision and presentation of comparator, concomitant medication and rescue mediation to meet study requirements
- Draft clinical label text for review and approval
- Liaise with local and central teams and CRO, as required, to ensure that study start up activities are in compliance with study timelines and local regulations
- Optimally compile and distribute the final CTAp dossier and subsequent Substantial amendments to country applicants, for submission to Ethics Committees and Competent Authorities
- Bachelor degree in Life Sciences, Allied Health, Pharmacy, Nursing
- Thorough understanding of GCPs, ICH Guidelines and local country guidelines or regulations as they apply to protocol/site management
- Knowledge of general clinical research including project management issues, important milestones and strategies to ensure timelines are met
- Knowledge of the pharmaceutical industry and of pre-clinical, clinical, regulatory and commercial components
Clinical Trial Specialist Job Description
- Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met
- Develop, send, collect, review, and process clinical trial related documents in compliance with requirements set forth by regulatory agencies (e.g., FDA, TPD, EMEA, ICH-GCP, SOPs and working practice guidelines)
- Set-up, maintain, oversee, reconciles and QC the trial master files
- Assist with the preparation of study amendments, model informed consent forms, laboratory manuals, and other clinical trial related documents as assigned
- Provide study status updates at regular intervals to operational study management team members
- Collaborates on the Clinical Operations team on the development of certain study specific plans and/or processes
- Train third parties on procedures and assist with system support
- Participate in cross functional internal study team meetings and take minutes as requested
- The Lead Clinical Trial Specialist reports to the Sr
- Perform quality control (QC) of Sponsor and/or Clinical Research Organization (CRO)-issued data queries to ensure the accuracy of site responses in EDC
- Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
- Capability to define process flows and procedures, to modify and improve them when necessary
- Proficient use of CTMS and related regulatory tracking systems
- Experience in Clinical Trial Application preparation and coordination, regulatory or equivalent in the pharmaceutical industry
- Demonstrated success in using oral and written communication and presentation skills to influence, inform or guide others
- Experience in effective implementation of clinical plans/documents and document preparation
Clinical Trial Specialist Job Description
- Support Clinical Operations and Clinical Data Management study team members relative to ongoing data review including running various data cleaning reports
- Coordinate the conduct of multicenter clinical trial protocols, including study site selection and activation, patient enrollment, electronic case report form design, specimen shipping, data monitoring, safety review, and other protocol-related tasks
- Track each site through local regulatory review and contract execution process, evaluate for recurrent problems, development and implement systems to decrease delay in site activation process
- Collect and review regulatory documents from participating sites prior to study activation, conduct study start-up meetings, maintain communication with sites to ensure high quality of data, timely submission of data, and adherence to guidelines
- Review subject eligibility and registration request
- Conduct on-site training and monitoring visits as needed
- For IND studies, maintain accurate and up-to-date documents and submissions
- Facilitate the full cycle of the protocol approval process – development, submission, contract negotiation, budget development, interaction with Cancer Center Cores
- Assist PI with abstracts and manuscripts preparation
- When needed, recruit and train research data management and regulatory personnel within the Program
- Clinical experience with [therapeutic area or disease] is preferred
- Ability to work in multiple parallel projects and share learnings
- Previous experience working in an international team environment within a matrix organisation
- Experience in planning and coordination of study initiation
- Bachelor's degree in in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required
- Relevant advanced degree in life sciences is preferred