FSP Experienced Clinical Research Associate (CRA II/Sr. CRA I) - Oncology

Thermo Fisher Scientific is hiring an experienced Clinical Research Associate to conduct and coordinate clinical monitoring and site management for oncology trials. The role focuses on regulatory compliance, data reliability, investigator-site collaboration, and trial progress from site initiation through closeout.

Tags

Health Care

Life Science

Pharmaceutical

Artificial Intelligence (AI)

Accounting

Human Resources

Healthcare

Publishing

Biopharma

Bookkeeping and Payroll

Employment

Freelance

Responsibilities

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

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, CTMS). Performs QC check of reports generated from CTMS system where required

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. Ensures 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

Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc)

Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts

Responds to company, client and applicable regulatory requirements/audits/inspections. Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner

Contributes to other project work and initiatives for process improvement, as required

Preferred

Ideally candidates will have up to 2 years of monitoring experience, though more experienced candidates can be considered if needed

Benefits

Remote work arrangement

AI-powered talent hiring platform for life sciences, pharma, and IT.

London, England, GBR

https://lifelancer.com

Total Funding

$0.68M

2025-03-01

Pre Seed· $0.24M

2024-03-01

Pre Seed· $0.11M

2023-03-01

Pre Seed· $0.12M

Leadership Team

Jayesh Pandya

Co-Founder & CEO

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Qualifications

Bachelor's a life sciences related field or a Registered Nurse Certification or equivalent and relevant formal academic/vocational qualification

Minimum of 1 year of oncology monitoring experience, OR minimum of 2 years of standard monitoring experience with relevant prior clinical experience (e.g., MD, RN, Study Coordinator)

Effective clinical monitoring skills

Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents

Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving

Ability to manages Risk Based Monitoring concepts and processes

Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues

Effective interpersonal skills

Strong attention to detail

Effective organizational and time management skills

Ability to remain flexible and adaptable in a wide range of scenarios

Ability to work in a team or independently as required

Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software

Good English language and grammar skills

Good presentation skills

Ideally candidates will have up to 2 years of monitoring experience, though more experienced candidates can be considered if needed

Minimum of 1 year of oncology monitoring experience, OR minimum of 2 years of standard monitoring experience with relevant prior clinical experience (e.g., MD, RN, Study Coordinator).

Required skills

Oncology Monitoring, Clinical Monitoring, ICH-GCP, Applicable Clinical Trial Regulations, Risk-Based Monitoring, Root Cause Analysis, Medical Terminology, Microsoft Office

Experience

1+ years