CRA II

📣 إعلان

منذ ساعة واحدة تقريباً

	نوع العقد	دوام كامل
	طبيعة الوظيفة	عن بُعد
	الموقع	الرياض

وصف الوظيفة

About the Role

Thermo Fisher Scientific is seeking a Clinical Research Associate (CRA II) to join their global team in Riyadh, Saudi Arabia. This full-time role involves performing and coordinating all aspects of clinical monitoring and site management processes. The CRA II will ensure trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and Standard Operating Procedures (SOPs) to safeguard subjects' rights, well-being, and data reliability.

Role Context and Impact

As a CRA II, you will conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. The role involves managing procedures and guidelines from various sponsors and monitoring environments. You will act as a site processes specialist, ensuring audit readiness and developing collaborative relationships with investigational sites. The company has a track record of supporting top pharmaceutical companies and biotechs across numerous clinical trials globally.

Key Responsibilities

Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions.
Ensure data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review via on-site and remote monitoring activities.
Assess investigational products through physical inventory and records review.
Document observations in reports and letters in a timely manner, adhering to approved business writing standards.
Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
Maintain regular contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording.
Conduct monitoring tasks in accordance with the approved monitoring plan.
Participate in the investigator payment process and ensure shared responsibility with other project team members for issue resolution.
Investigate and follow up on findings as applicable, and participate in investigator meetings as necessary.
Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
Initiate clinical trial sites according to relevant procedures, ensuring compliance with protocol, regulatory, and ICH-GCP obligations.
Perform trial close-out and retrieval of trial materials.
Ensure required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
Conduct on-site file reviews as per project specifications and provide trial status tracking and progress update reports to the Clinical Team Manager (CTM).
Ensure study systems are updated per agreed study conventions (*, Clinical Trial Management System).
Facilitate effective communication between investigative sites, the client company, and the PPD project team.
Respond to company, client, and applicable regulatory requirements/audits/inspections.
Complete administrative tasks such as expense reports and timesheets in a timely manner.
Contribute to the project team by assisting in the preparation of project publications/tools and sharing ideas/suggestions.
Contribute to other project work and initiatives for process improvement as required.

Experience and Qualifications

0-1 years of relevant experience.

Work Environment

Work is performed in an office, laboratory, clinical, and/or home office environment with exposure to electrical office equipment. The role requires frequent drives to site locations and frequent travel, generally 60-80%, which may include extended overnight stays. There is potential exposure to biological fluids with infectious organisms, requiring personal protective equipment such as protective eyewear, garments, and gloves. Occasional exposure to fluctuating and/or extreme temperatures may occur.