Senior Clinical Research Associate

This is a fully remote position, open to applicants in Greece.

📋 Description

• Oversees investigator sites using a risk-based monitoring strategy: employs root cause analysis (RCA), critical thinking, and problem-solving abilities to identify failures in site processes and implement corrective/preventive actions to achieve compliance and mitigate risks. Ensures data integrity through SDR, SDV, and CRF reviews as necessary, utilizing both on-site and remote monitoring methods. Evaluates investigational products via physical inventory and record assessments. Timely documents findings in reports and letters adhering to approved business writing standards. Promptly escalates noted deficiencies and issues to clinical management and follows up on all matters until resolution. Maintains regular communication with investigative sites between monitoring visits to verify adherence to the protocol, facilitate the resolution of previously identified issues, and ensure timely data recording. Executes monitoring tasks in alignment with the approved monitoring plan. Participates in the investigator payment process. Shares responsibility with other project team members for issue and finding resolutions. Investigates and follows up on findings as necessary.

• Delivers trial status tracking and progress reports to the Clinical Team Manager (CTM) as needed. Ensures that study systems are updated in accordance with agreed study conventions (e.g., Clinical Trial Management System, CTMS). Conducts quality control checks on reports generated from the CTMS as required.

• Engages in investigator meetings as necessary. Collaborates with the client company to identify potential investigators, ensuring the suitability of qualified investigative sites. Initiates clinical trial sites following relevant procedures to guarantee compliance with protocols, regulatory requirements, and ICH GCP obligations, providing recommendations when appropriate. Ensures trial closure and the retrieval of trial materials.

• Verifies that essential documents are complete and in accordance with ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.

• Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas and suggestions with team members. Takes on additional study tasks assigned by the CTM (e.g., reviewing trip reports, creating newsletters, leading CRA team calls, etc.).

• Facilitates effective communication among investigative sites, the client company, and the PPD project team through written, verbal, and/or electronic interactions.

• Addresses company, client, and applicable regulatory requirements, audits, and inspections.

• Completes administrative tasks such as expense reports and timesheets in a timely manner.

• Contributes to other project initiatives and efforts for process improvement as required.

⛳️ Requirements

• A bachelor's degree in a life sciences field or an equivalent and relevant formal academic/vocational qualification.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (comparable to 2+ years as a clinical research monitor).

• Preferred experience in Oncology/Hematology.

• A valid driver's license, where applicable.

• In some instances, a combination of appropriate education, training, and/or directly related experience will be deemed sufficient to meet the role's requirements.

• Proficient clinical monitoring skills.

• Demonstrated understanding of medical and therapeutic area knowledge, as well as medical terminology.

• Excellent grasp and demonstrated application of ICH GCPs, applicable regulations, and procedural documents.

• Well-honed critical thinking abilities, including but not limited to a critical mindset, thorough investigation for accurate root cause analysis, and effective problem-solving.

• Capable of managing Risk-Based Monitoring concepts and processes.

• Strong oral and written communication skills, with the ability to effectively engage with medical professionals.

• Ability to maintain a customer-centric approach through effective listening, attention to detail, and the capacity to identify underlying customer issues.

• Strong interpersonal skills.

• Excellent attention to detail.

• Effective organizational and time management capabilities.

• Ability to remain flexible and adaptable in a variety of situations.

• Capability to work collaboratively in a team or independently as needed.

• Proficient computer skills: adept knowledge of Microsoft Office and the ability to learn relevant software.

• Strong command of the English language and grammar.

• Good presentation skills.

🏝️ Benefits

• Work Conditions and Environment:

• Work is conducted in an office/laboratory/clinical and/or home office setting with exposure to electrical office equipment.

• Frequent travel to site locations, generally 60-80% but potentially more for some individuals.

• May also involve extended overnight travel.

• Exposure to biological fluids with potential contact with infectious organisms.

• Personal protective equipment such as eyewear, garments, and gloves is required.

• Occasional exposure to fluctuating and/or extreme temperatures.

• Must comply with specific sponsor/client/site requirements, even if not mandated by Thermo Fisher Scientific (e.g., disclosure of vaccination status or other personal information).