Senior Clinical Research Associate (Oncology Experience Required) - UK (Remote) - FSP - REGISTER YOUR INTEREST
Parexel, Uxbridge, England, United Kingdom
REGISTER YOUR INTEREST FOR UPCOMING ONCOLOGY FOCUSED SENIOR CLINICAL RESEARCH ASSOCIATE OPPORTUNITIES. Recent oncology experience will be essential.
Responsibilities
* Oversight of monitoring responsibilities and study conduct: ensure regulatory, ICH-GCP and protocol compliance; evaluate site performance; communicate significant issues to the project team; develop action plans; maintain knowledge of ICH/GCP guidelines, regulations, and SOPs.
* Verify informed consent process for each subject is adequately performed and documented.
* Protect subject confidentiality and assess factors affecting subject safety and data integrity (e.g., protocol deviations, pharmacovigilance issues).
* Conduct monitoring activities per CMP/SMP, using on-site or remote methods as allowed by country regulations.
* Perform source data review and verify accuracy/completeness of CRFs and site source documents.
* Manage reporting of protocol deviations and follow-up; apply query resolution techniques remotely and on-site; drive closure within timelines.
* May perform Investigational Product (IP) inventory, reconciliation, storage and security checks; verify IP dispensing per protocol and issues related to blinded or randomized IP information.
* Ensure IP labeling, import/export, and release meet GCP/local requirements; manage issues and follow-up to resolution.
* Document activities via follow-up letters, monitoring reports, communication logs, and other project documents per SOPs, CMP, and SMP.
* Ensure appropriate delegation and training of site personnel; track activities in required systems; manage site-level activities, budgets, and timelines; adapt to changing priorities to meet goals.
* Review data entry timeliness, missing pages, outstanding queries, and database lock timelines.
* Review site signatures and delegation of duties logs; assess training compliance for staff with updated requirements (e.g., protocol amendments).
* Follow up on escalated adverse event monitoring (AEM) report queries.
* Check site and external facilities, equipment, and supplies are adequate for the trial and monitor expiry dates where applicable.
* Ensure site-specific logs (e.g., Site Visit Log, Screening/Enrollment Log, Signature Sheet, Delegation of Duties Log, IP Accountability Log) are complete and up to date.
* Coordinate with Site Manager as primary liaison with site personnel; participate in Investigator Meetings and sponsor meetings as applicable; contribute to global monitoring discussions and client meetings.
Qualifications & Skills
* Networking and relationship-building skills; ability to communicate effectively with internal and external stakeholders.
* Adaptability to changing technologies and processes; ability to overcome barriers in implementing new processes and systems.
* Excellent verbal and written communication, presentation, and interpersonal skills with colleagues and external partners.
* Ability to build effective relationships with investigator site staff and stakeholders.
* Proficiency in local language is required; advanced English proficiency is required.
* Education: Bachelor’s degree or Registered Nurse (RN) in a related field, or equivalent combination of education, training, and experience.
What We Offer
Join Parexel to contribute to clinical studies across therapeutic areas. We support trials for a broad client base and offer collaboration with a wide team.
EEO statement and other legally required notices remain in effect as applicable.
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