FSP CRA Level I

Work Schedule

Environmental Conditions

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.

Travel requirement 50%- 75%

Qualifications:
Education and Experience:
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.

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 drives 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.
Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site.