FSP Bench Clinical Research Associate I

ThermoFisher Scientific; Colombia; Remote; COP 42,000,000 - 75,000,000; Full time

Job summary

ThermoFisher Scientific seeks a Clinical Monitor to oversee investigator sites using risk-based monitoring. You will ensure data accuracy, perform SDR/SDV/CRF reviews, and uphold ICH-GCP and regulatory standards both on-site and remotely.

Travel is extensive, and you will coordinate with project teams to resolve issues and ensure protocol adherence throughout the trial lifecycle.

Qualifications

• Minimum clinical monitoring experience in a clinical environment where trials are conducted.
• Strong knowledge of medical terminology and regulatory requirements.
• Ability to perform data quality reviews and adherence to ICH-GCP.

Responsibilities

• Monitors investigator sites using a risk-based monitoring approach.
• Ensures data accuracy through SDR, SDV and CRF review during on-site and remote visits.
• Maintains regulatory compliance and communicates findings to management.
• Conducts site initiation, monitoring, and close-out activities per plan.

Skills

Clinical monitoring

Education

Bachelor's degree in life sciences or RN certification

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 higher than 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

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.