The World Leader In Serving Science
FSP CRA (Level II)
Location
China
Posted
1 day ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
FSP CRA (Level II)
Thermo Fisher Scientific
Role Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Summarized Purpose: - Performs and coordinates different aspects of the clinical monitoring and site management process. - Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. - Acts as a site processes specialist, ensuring compliance with approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs. - Ensures audit readiness and develops collaborative relationships with investigational sites. Key responsibilities: - Monitors investigator sites with a risk-based monitoring approach. - Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failure and corrective/preventive actions. - Ensures data accuracy through SDR, SDV, and CRF review as applicable. - Documents observations in reports and letters in a timely manner using approved business writing standards. - Escalates observed deficiencies and issues to clinical management expeditiously. - Maintains regular contact between monitoring visits with investigative sites. - Conducts supervising tasks in accordance with the approved monitoring plan. - Participates in the investigator payment process. - Ensures shared responsibility with other project team members on issues/findings resolution. - Identifies potential investigators in collaboration with the client company. - Initiates clinical trial sites according to relevant procedures. - Performs trial close out and retrieval of trial materials. - Ensures that required crucial documents are complete and in place. - Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM). - Facilitates effective communication between investigative sites, the client company, and the PPD project team. - Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. - Contributes to the project team by assisting in preparation of project publications/tools. - Contributes to other project work and initiatives for process improvement. Qualifications - Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent. - Previous experience comparable to 1 year as a clinical research monitor or completion of PPD Drug Development Fellowship. - Valid driver's license where applicable. Requirements - Proven clinical monitoring skills. - Demonstrated understanding of medical/therapeutic area knowledge and medical terminology. - Ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations, and procedural documents. - Well-developed critical thinking skills, including root cause analysis and problem solving. - Ability to manage Risk Based Monitoring concepts and processes. - Good oral and written communication skills. - Ability to maintain customer focus through good listening skills and attention to detail. - Good organizational and time management skills. - Effective interpersonal skills. - Attention to detail. - Ability to remain flexible and adaptable in a wide range of scenarios. - Ability to work in a team or independently as required. - Good digital literacy: solid knowledge of Microsoft Office. - Good English language and grammar skills. - Good presentation skills. Benefits - Competitive remuneration and annual incentive plan bonus. - Healthcare and a range of employee benefits. - Employment with an innovative, forward-thinking organization. - Outstanding career and development prospects. - Exciting company culture that stands for integrity, intensity, involvement, and innovation.
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