CRA I - FSP

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix Essential Functions Monitors investigator sites using a risk-based monitoring approach. Applies root cause analysis (RCA), critical thinking, and problem-solving skills to: Identify site process failures. Determine corrective and preventive actions. Bring sites into compliance. Reduce study and site-level risks. Ensures data accuracy through: Source Data Review (SDR). Source Data Verification (SDV). Case Report Form (CRF) review, as applicable. 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 promptly and follows issues through to resolution. Maintains regular contact between monitoring visits with investigative sites, as needed, to confirm: Protocol compliance. Resolution of previously identified issues. Timely recording of study data. Conducts monitoring activities in accordance with the approved monitoring plan. Participates in the investigator payment process. Shares responsibility with other project team members for issue and finding resolution. Investigates and follows up on findings, as applicable. Participates in investigator meetings as necessary. May assist in identifying potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites in accordance with relevant procedures to ensure compliance with: Study protocol. Regulatory requirements. ICH-GCP obligations. Makes recommendations regarding site compliance where warranted. Performs trial close-out activities and retrieves trial materials. Ensures required essential documents are complete and in place according to ICH-GCP and applicable regulations. Conducts on-site file reviews according to project specifications. Provides trial status tracking and progress updates to the project team as required. Ensures study systems are complete, accurate, and updated according to agreed study conventions, including the Clinical Trial Management System (CTMS). Facilitates effective communication between: Investigative sites. Client companies. Internal project teams. Communicates through written, oral, and/or electronic channels. Responds to company, client, and applicable regulatory requirements, audits, and inspections. Completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to project teams by assisting with the preparation of project publications and tools. Shares ideas and suggestions with team members. Contributes to project work and process-improvement initiatives as required. Travel requirement may exceed 75%. Job Complexity Works on problems of limited scope. Follows standard practices and procedures when analyzing situations or data. Handles situations where solutions can generally be readily obtained through established processes. Job Knowledge Develops knowledge of professional concepts relevant to the role. Applies company policies and procedures to resolve routine issues. Supervision Received Normally receives detailed instructions regarding assigned work. Business Relationships Primary contacts are with the immediate supervisor and other personnel within the department. Builds stable and effective internal working relationships. Qualifications Education and Experience Master's degree in a life sciences-related field (preferably Pharmacy) 1 to 2 years of independent Onsite Clinical Monitoring experience mandate Hands on experience in conducting site visits to conduct clinical trials across India. Experience in monitoring oncology trials is preferred. Knowledge, Skills and Abilities Basic medical and therapeutic-area knowledge. Understanding of medical terminology. Ability to attain and maintain working knowledge of: ICH-GCP requirements. Applicable regulations. Relevant procedural documents. Good oral and written communication skills. Ability to communicate effectively with medical personnel. Good interpersonal skills. Strong customer focus demonstrated through: Effective listening. Attention to detail. Ability to identify customers' underlying issues and needs. Good organizational and time-management skills. Ability to remain flexible and adaptable across a wide range of scenarios. Well-developed critical-thinking skills, including: Critical mindset. In-depth investigation. Root cause analysis. Problem solving. Ability to manage Risk-Based Monitoring concepts and processes. Ability to work independently or as part of a team, as required. Good computer skills, including: Solid knowledge of Microsoft Office. Ability to learn and use appropriate software systems. Good English-language and grammar skills.