About this role
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.