CRA I - FSP

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.