.Work Schedule: Standard (Mon-Fri)Environmental Conditions: OfficeJob Description:Essential Functions and Other Job Information: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.Assesses investigational product through physical inventory and records review.Documents observations in reports and letters in a timely manner using approved business writing standards.Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.Maintains 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.Conducts monitoring 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.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).Facilitates effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts.Qualifications:Education and Experience:Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.Valid driver's license where applicable.Working Conditions and Environment:Work is performed in an office/laboratory/clinical and/or home office environment with exposure to electrical office equipment