Lead Clinical Research Associate
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Lead Clinical Research Associate managing CRA and CTA teams in clinical studies. Ensuring best practices in clinical monitoring activities in the pharmaceutical and medical device industries.
Responsibilities:
- Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study
- Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements
- Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies
- Create annotated visit report templates and other documents and strategies related to site management and monitoring
- Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented
- Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements
- Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control
- Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team
- Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed
Requirements:
- RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training
- Previous CRA experience preferred
- Proven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy
- Solutions-oriented approach to problem solving
- Familiarity with medical and pharmaceutical industry, and related terminology and practices
- Extensive knowledge of Food and Drug Administration regulations and their practical implementation
- Willingness to travel and perform remote and on-site monitoring, if needed
- Proficiency in Microsoft Word, Excel, and PowerPoint
Similar Jobs
Desk Research Specialist
Senior Desk Research Specialist for Ek Kutumb conducting rigorous research into values and beliefs shaping communities across India. Anchoring secondary research and promoting informed policy design.
Qualitative Research Associate
Qualitative Research Associate at Ek Kutumb conducting research on social values and community beliefs. Engaging with diverse communities across India to gather qualitative insights on social change.
Research Associate, Survey – Education
Research Associate managing survey administration and project logistics for Hanover Research's growing enterprise. Collaborating with project managers and external vendors to streamline survey processes.
In-House Clinical Research Associate
In-House Clinical Research Associate at ICON plc supporting the execution and management of clinical trials. Contributing to innovative treatments and therapies.
Senior Research Consultant – On Call
On-call Senior Research Consultant providing expertise on workforce development and research. Collaborating with clients to lead and support strategic consulting projects in social issue areas.
Senior Clinical Research Associate, Site Manager
Senior Clinical Research Associate overseeing clinical trials in compliance with regulations. Collaborating with study centres and ensuring quality while managing study documentation and data validation.
Research Associate, SEPP
Research Associate contributing to projects in special education and policy evaluation at WestEd. Collaborating on research proposals and coordinating project management activities.
Research Associate – Teaching and Learning
Research Associate conducting educational research and evaluation projects at WestEd. Collaborating with teams to develop evidence-based solutions for special education and learner variability.
Property Research Analyst
Property Research Analyst supporting appraisal process with in-depth property research and data collection. Analyze market trends and work closely with appraisers to ensure data accuracy and completeness.
Senior Clinical Research Associate, Clinical Research Associate II
Senior Clinical Research Associate responsible for site management and monitoring of clinical trials across the US. Ensuring compliance and safety while enhancing investigator site relationships in line with GCP standards.
Research Associate I
Research Scientist maintaining and troubleshooting scientific research equipment in Antarctica for the National Science Foundation. Support diverse research projects while ensuring effective operation of scientific instrumentation.
Market Research Analyst, Data Insights
Market Research Analyst in global healthcare intelligence company providing insights through technology. Contributing to market research project execution across all phases in support of client growth.
Clinical Research Associate – All Levels
Clinical Research Associate supporting clinical trials for patients with chronic eye conditions at SpyGlass Pharma. Conducting monitoring visits and collaborating with site staff across the United States.
Market Research Analyst
Market Research Analyst at a creative agency transforming data into actionable strategies. Focused on deep research and collaboration with brand and campaign development teams.
Education Communications Research Associate Intern, Master's Students
Education Communications Research Associate Intern supporting education research and communications initiatives for AIR. Gaining hands-on experience while collaborating with experts in the field.
Senior Clinical Research Associate, CRA
Senior Clinical Research Associate overseeing study monitoring visits and ensuring adherence to protocols. Supporting clinical trials in a remote capacity from the United States.
Clinical Research Associate
Clinical Research Associate ensuring compliance and quality in clinical trials. Conducting site monitoring visits and collaborating with teams to maintain trial standards.
Senior Clinical Research Associate - FSP
Overseeing monitoring responsibilities and ensuring proper conduct of clinical trials at Parexel. Collaborating with sites and managing operational aspects of clinical research in South Korea.
Clinical Research Associate II – Oncology Experience Preferred
Clinical Research Associate II responsible for managing and monitoring oncology studies. Collaborating with industry leaders and mentoring junior CRAs in a remote setting.
Lead Generation, Research Analyst
Research Analyst responsible for generating and validating leads for logistics sales through extensive research and data validation. Collaborating with sales support teams in a data-driven environment.