Clinical Research Associate Goals and Objectives Examples
Ensure compliance with all applicable regulations and guidelines.
Maintain appropriate documentation of clinical study activities.
Monitor clinical trial progress to ensure that objectives are being met.
Ensure that study protocols are being followed.
Perform site qualification visits.
Identify and report adverse events.
Manage clinical trial budgets.
Develop and maintain relationships with investigators and site staff.
Conduct initiation, monitoring, and closeout visits.
Prepare and review study-related documents, such as study plans, CRFs, and informed consent forms.
Verify the accuracy of clinical data.
Ensure that data is collected in a timely manner.
Implement quality control measures to ensure data accuracy.
Develop and maintain study timelines.
Coordinate with internal and external teams to ensure the successful completion of study milestones.
Effectively communicate with sponsors, investigators, and site staff.
Provide guidance to investigators on study requirements.
Train site staff on study procedures and requirements.
Collect and maintain essential regulatory documents.
Attend investigator meetings.
Conduct feasibility assessments for new studies.
Participate in the development of SOPs and work instructions.
Assist with audit preparations.
Participate in internal quality control activities.
Contribute to the development of clinical development plans.
Assist with the preparation of IND applications and clinical trial submissions.
Stay up-to-date with regulatory and industry developments.
Contribute to the development of safety management plans.
Manage investigational product accountability at sites.
Provide support for clinical trial monitoring activities.
Review electronic health records for eligibility criteria assessment.
Maintain current knowledge of trial design principles, practices, and standards.
Assist with site selection and recruitment strategies for trials.
Assist in risk mitigation strategies through root cause analysis or other quality management tools.
Participate in the development of trial templates (e.g., CRFs).
Study start-up support including but not limited to protocol review, Investigator meeting agenda creation/facilitation, material creation & distribution, CTMS access set-up/management, etc.
Prepare interim and final clinical reports for submission to regulatory authorities.
Act as a liaison between sponsor, investigator, and CRO.
Prepare case report forms (CRFs) for data collection purposes.
Prepare study metrics reports.
Communicate safety concerns to sponsor via EDC system or sponsor designated safety reporting tools, escalating where necessary.
Oversee Trial Master File management ensuring completeness throughout the life-cycle of the trial.
Attend investigator meetings and provide study overview presentations when required.
Serve as a resource for team members with less experience.
Co-monitor heavily enrolling sites where needed.
Maintain awareness of ICH GCP guidelines and updates to guidelines.
Coordinate development and maintenance of project plans including information relating to timelines, deliverables, resources and budgets.
Communicate regularly with Clinical Trial Manager regarding status of assigned tasks and progress towards deliverables.
Prepare training materials and provide training on best clinical practice.
Undertake independent problem solving around operational issues.
Assist in developing project-specific procedures, templates, tools and systems.
Liaise directly with sponsors or third parties as appropriate.
Conduct/Participate in exploratory calls with potential investigative sites.
Provide regular recruitment updates to Sponsor/Clinical Trial Manager/Clinical Research Manager.
Service escalation point for site based operational questions.
Review health record data for eligibility & safety criteria; providing feedback to investigative site personnel.
Participate in site qualification visits.
Interact with hospitals, clinics or other facilities involved in recruitment activities.
Prepare reports summarizing recruitment activity& measurements against targets.
Ensure trial databases are up-to-date and accurate including any CTMS systems.
Draft Informed Consents/Legal Authorizations.
Facilitate resolution of queries generated from central Data Management team thereby maintaining data quality while aiding data flow processes.
Pre-populate EDC data checks/checklists.
Provide training on site level setup activities including Environment Health and Safety Topics.
Analyze site performance metrics.
Participation in creation of projected/enrollment rates.
Regularly update CTMS systems.
Provide ongoing Site Communication around updates/changes to protocols etc. involving additional training if needed.
Approve invoices associated with payments for investigative sites.
Manage screening logs & trackers for individual sites including data quality checks.
Build relationships with investigative site personnel proactively addressing issues.
Reconcile final Adverse Event counts.
Provide input into monitoring visit reports including methodology used for communication between monitor and investigative site personnel during a monitoring visit.
Serve as backup Clinical Trial Manager if needed.
Identify potential risks during day-to-day activities escalating them as necessary.