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ICON Strategic Solutions · 1 month ago

Senior Clinical Research Associate- Oncology

Texas, United States

Full-time

Hybrid

Mid, Senior Level

4+ years exp

ICON Strategic Solutions is a company focused on clinical research, and they are seeking a Senior Clinical Research Associate specializing in oncology. The role involves managing clinical trial activities, ensuring compliance with regulations, and maintaining communication with stakeholders to facilitate successful study execution.

Pharmaceuticals

H1B Sponsor Likely

Hiring Manager

Christine Kuebler

Responsibilities

Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing

Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity

Strong planning & organizational skills, and the ability to work efficiently and effectively

Proactive, conscientious and precise in delivery of quality work even when under pressure

Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely manner

Flexible with high learning and change agility

Knowledge of local regulations, IND/ICH GCP - guidelines

Available and willing to travel as job requires

Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team

Engage and maintain good written and verbal communication with external stakeholders in order to ensure effectiveness

Accountable for local activities required in set up and for high quality execution of studies; will seek managerial or other experienced support as appropriate

Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out

Determines the feasibility of the study protocol with reference to study complexity

Confirms staff availability, suitable clinical facilities, potential for per protocol patient population

Confirms ability to comply with ICH GCP and requirements for clinical studies

Works with Study staff to carry out a local study / site level risk

Participate in global investigators and/or monitor meetings as appropriate. Facilitates investigator’s participation in global meetings and/or may assist the study staff with organizing local investigator Participates in other study meetings as required

Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are

Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP)

Work with the sites to ensure they address data queries in a timely Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time

Ensure Investigator and site staff receives safety reports and new safety information in a timely manner

Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to safety department and other relevant departments, within the required time frames

Completes monitoring visit reports within the agreed timelines

Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS)

Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately

Ensure sponsor study records are inspection ready at all times and archives records as applicable

Qualification

Clinical monitoring experienceICH regulationsClinical research experienceCoaching/mentoring CRAsFluent in EnglishPlanningCommunication skillsOrganizational skillsProblem-solving skillsFlexibilityAdaptability

Required