Parexel is recruiting a Senior Clinical Research Associate (CRA) based in the UK. The role requires experience in oncology trials and RECIST criteria, and a minimum of three years of experience in CRO or pharma trial environments.
Responsibilities
* Ensuring regulatory, ICH-GCP and protocol compliance.
* Evaluating overall performance of the site and site staff, providing recommendations and developing action plans.
* Maintaining knowledge of ICH/GCP guidelines, regulations and SOPs.
* Verifying informed consent procedures are properly performed and documented.
* Protecting subject confidentiality and assessing safety and data integrity risks.
* Conducting monitoring activities using on‑site and remote methods approved by regulations.
* Performing source document review and verifying data integrity in the CRF.
* Reporting protocol deviations and following up.
* Resolving queries locally and remotely, driving closure within timelines.
* Managing investigational product inventory, reconciliation, storage and security.
* Verifying product dispensation and administration per protocol.
* Ensuring product labeling, import, release and return follow GCP and local regulations.
* Documenting activities via letters, reports, logs, and other required project documents.
* Ensuring activities are performed by trained and delegated site personnel.
* Entering data into tracking systems to monitor observations, status and action items.
* Monitoring data entry timeliness, missing pages and outstanding queries.
* Verifying delegation of duties logs and training compliance.
* Conducting follow‑up for adverse event monitoring queries.
* Checking site and external facility supplies and equipment for adequacy and expiry.
* Ensuring site logs are complete and current.
Collaboration
* Collaborating with the primary Site Manager as the main liaison.
* Preparing for and attending investigator, sponsor and global monitoring meetings.
* Participating in project staff meetings and client representation sessions.
Skills
* Networking and relationship building skills.
* Effective communication with internal and external stakeholders.
* Adaptation to changing technologies and processes.
* Excellent verbal, written, presentation and interpersonal skills.
* Building effective relationships with investigator site staff.
* Proficiency in the local language (required).
* Fluency in English (required).
Education
Bachelor’s degree or Registered Nurse (RN) in a related field, or an equivalent combination of education, training and experience.
#J-18808-Ljbffr