Senior Clinical Research Associate, ECD, St. Petersburg
Clinical Research Associate
Duties and Responsibilities:
Meets all requirements of the applicable preceding Clinical Research Associate level
May participate in identification/feasibility and recruitment of investigator sites, collection of investigator documentation, pre-study visits and site management responsibilities.
Creates site reference manuals and other site training materials
Generates study specific monitoring plans
May serves as the Primary contact for the sponsor/clinical sites
Organizes and delivers presentations at Sponsor and Investigator/Initiation Meetings.
Assures implementation of Project Plans related to the Clinical Monitoring responsibilities
May assist in Bid Defenses and Business Development including proposal generation and feasibility tasks.
May participate in the development of protocols and Case Report Forms
Develops contingency plans and alternate strategies
General on-site Monitoring Responsibilities:
Ensures that study staff conducting the protocol have received the proper materials, instructions and training to safely enter subjects into the study and complete the protocol requirements, as written.
Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensures the integrity of the data submitted on CRFs or other data collection tools by careful source document review.
Ensures that the Site Regulatory Documents are complete and current throughout the duration of the trial.
Ensures that the study compound inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
Ensures the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy.
Prepares accurate and timely trip reports.
Identification and follow up of SAEs at study site for which he/she is responsible
Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems.
May serves as Project Manager for small-mid sized studies
May manage/assist with complex clinical projects and lead project teams
May serves as lead CRA for a protocol or project.
Responsible for coordinating initial and on-going protocol, CRF and monitor training.
specifics, ensures consistency at study sites and leverages best practices. Responsible for overseeing CRA performance, reviewing trip reports for content and timeliness.
Tracks progress of projects and initiates appropriate actions to achieve target objectives.
Oversees the development of the conventions for CRF transcription
Co-manages fiscal responsibilities (e.g. fiscal responsibility for tracking the monitoring expenses against the project budget)
May be responsible for the coordination of vendor activities, including translation of study documents
Interacts with internal work groups to evaluate needs, resources and timelines
Education / Qualifications
University/college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
Thorough knowledge of ICH guidelines, GCP and the clinical trial process
Thorough knowledge of the drug development process
Demonstrated ability to independently manage complex clinical projects