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.