FSP - CRA (Level I)

Job Description

Monitors investigator sites with a risk-based monitoring approach: applies root

Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site

processes failure and corrective/preventive actions to bring the site into

compliance and decrease risks. Ensures data accuracy through SDR, SDV and

CRF review as applicable through on-site and remote monitoring activities.

Assess 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 expeditiously and follow all issues through to resolution.

May need to maintain regular contact between monitoring visits with

investigative sites to confirm that the protocol is being followed, that previously

identified issues are being resolved and that the data is being recorded in a

timely manner. Conducts monitoring tasks in accordance with the approved

monitoring plan. Participates in the investigator payment process. Ensures a

shared responsibility with other project team members on issues/findings

resolution. Investigates and follows-up on findings as applicable.

Participates in investigator meetings as necessary. May help to identify potential

investigators in collaboration with the client company to ensure the acceptability

of qualified investigative sites. Initiates clinical trial sites according to the

relevant procedures to ensure compliance with the protocol and regulatory and

ICH GCP obligations, making recommendations where warranted. Performs trial

close out and retrieval of trial materials.

Ensures that required essential documents are complete and in place, according

to ICH-GCP and applicable regulations. Conducts on-site file reviews as per

project specifications.

Provides trial status tracking and progress update reports to the team as

required. Ensures study systems are complete, accurate and updated per agreed

study conventions (e.g. Clinical Trial Management System).

Facilitates effective communication between investigative sites, the client

company and internal project teams through written, oral and/or electronic

contacts. Responds to company, client and applicable regulatory

requirements/audits/inspections.

Maintains and completes administrative tasks such as expense reports and

timesheets in a timely manner.

Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.