CRA (Level II)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Essential Functions and Other Job Information:

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

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. Identifies 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 trialclose 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 Clinical Team

Manager (CTM) as required. Ensures study systems are updated per agreed

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

 Facilitates effective communication between investigative sites, the client

company and the PPD project team through written, oral and/or electronic

contacts

Qualifications:

Education and Experience:

Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.

Valid driver's license where applicable.

Working Conditions and Environment:

 Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to Electrical office equipment.

 Frequent aims to site locations. Frequent travel, generally 60-80% but more for some individuals.

May also include extended overnight stays.

 Exposure to biological fluids with potential exposure to infectious organisms.

 Personal protective equipment required such as protective eyewear, garments and gloves.

 Exposure to fluctuating and/or extreme temperatures on rare occasions