Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title: Contract Clinical Research Associate
Location: United Kingdom
Function: Clinical Operations
DESCRIPTION
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Primary point of contact for site personnel during life cycle of clinical trial. This includes study start up support, site activation, trial conduct and closeout of a clinical trial.
- Provides support to the Global Project Lead and CTM during project start up to ensure timely site selection and feasibility. Assists with collection of essential documents from the site. May assist with submission of central EC Applications, Local EC applications, RA applications and any other local regulatory applications/Approvals required.
- Ability to identify protocol deviations and pharmacovigilance issues that might affect data accuracy or patient safety.
- Conduct Site qualification, site initiation, routine site monitoring close out visits (remote and onsite), Central monitoring in compliance with study protocol and ICH-GCP.
- Expert documentation of monitoring priorities/activities via site visit confirmation and follow up letters, monitoring visit reports, and any trial associated logs.
- Oversees conduct trials by reviewing study data listings, vendor dashboards, and CTMS issues/actions documentation to identify trends, errors, and any potential breeches that can impact data integrity.
- Ability to present essential function of CRA role in Bid Defenses, Investigator Meetings, and Sponsor Face to Face meetings.
- Assists the Global Project Lead in identification of out-of-scope activities.
- Basic understanding of assigned projects scope, milestones and budget and manages site level activities to ensure project deliverables are met.
- Provides support to the CTM and Global project lead in negotiation of site budgets and contracts.
EDUCATION AND EXPERIENCE REQUIRED:
- Minimum of 3 Years of independent drug trial monitoring required
- Bachelors degree required
- Study-Start-Up (SSU) experience
- Device experience preferred
- Experience with the following therapeutic area(s): PBC/Rare Disease/Liver disease preferred
EMPLOYMENT TYPE:
Contractor; .2-.5 FTE
COMMITMENTS:
- .2 to .5 FTE flexibility
DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law
