Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description This position is eligible for a sign-on bonus, in accordance with company policy.FSP CRA (Sponsor: Biogen)

Thrive in multi-national project teams and be focused on delivering exemplary levels of customer service on multiple, exciting projects.
Have excellent communication and social skills and are looking to work in a collegiate environment where you want to take true ownership for your work.
Perform and coordinate all aspects of the clinical monitoring process. You shall also be qualified to conduct monitoring activities independently.
Benefit from award winning training programmes that will assist your technical and professional skills and knowledge.

• 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 to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Documents observations in reports and letters according to timelines using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).

Keys to Success:

• Education
• University degree in a nursing / life-sciences field
• Experience
• Experience of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation (at least for 2 years)- “Neurology experience preferred.
• Knowledge, Skills, Abilities- Demonstrated understanding of ICH-GCP, MFDS and FDA requirements
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Exceptional communication, collaboration, organisational and time management skill
• Fluency in English languages