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.

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