CRA I - FSP

Work Schedule

Environmental Conditions

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.