Home Study Writer Jobs in Spring, TX (NOW HIRING)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

What You Will Do:

• Acts as primary local company contact for assigned sites for specific trials.Trials may include both early and late phase clinical trials.

• Develops meaningful site relationships through consistent collaborative communication and engagement.

• Mayparticipatein site feasibility and/or pre-trial site assessment visits

• Attends/participatesin investigator meetings as needed.

• Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs)and policies. Responsible for the implementation ofrisk basedmonitoring approaches at the site level and to work withsiteto ensuretimelyresolution of issues found during monitoring visits.

• Ensures site staff aretrainedand the corresponding training records are complete andaccurateat any time point during all trial phases. Responsible in close collaboration withstudyteam for the activities during site activation phase to speed up the process and activate the site in the shortest possibletimeframe.

• Ensure site compliance with study protocol, ICH-GCP, and local/country regulations

• Ensure ongoing adequacy of site (facilities, staff) for trial conduct

• Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA

• Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.

• Ensures site non-IMP study supplies are adequate for trial conduct.

• Ensures that clinical drug supplies are appropriately used, handled, andstoredand returns are accurately inventoried and detailed.

• Oversees theappropriate destructionof clinical supplies.

• Ensures site staff complete data entry and resolve queries within expected timelines.

• Ensures validity and completeness of data collected at trial sites

• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented asappropriate.

• Maintains complete,accurateandtimelydata and essential documents in relevant systems used for trial management.

• Fullydocumentstrial related activities, in particular monitoring. Writes visit reports and follow-upletterin accordance withthe SOPs. Promptly communicates relevant status information and issues toappropriate stakeholders.

• Reviews study files for completeness andensuresarchiving retention requirements are met,including storage in a secure area at all times.

• Aligns withrelevant training requirements. Act aslocalexpert in assigned protocols. Develops therapeutic knowledge sufficient to supportroleand responsibilities.

• Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issuesidentifiedat the site during routine monitoring visits.

• Prepares trial sites for close out, conductfinalclose out visit.

• Establishes and maintains good working relationships with internal and externalstakeholdersin particular investigators, trial coordinators and other site staff.

• Mayparticipatein the Health Authority (HA) and IEC/IRB submission and notification processes asrequired/appropriate.

Your Profile:

• BA/BS degree with 3 years of experience in pharmaceutical related drug developmentor direct equivalent experience.

• Threeyearssite monitoring and/or site management experience.

• Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.

• Strong critical thinking andproblem solvingskills.

• Strong IT skills inappropriate softwareand company systems.

• Willingness to travel up to 40% with overnight stay away from home (though the goal is to focus on remote monitoring)

• Proficient in speaking and writing English. Depending on hiring region,mayalsobe requiredto be fluent inlocallanguage.

• Good written and oral communication.

• Oncology experience highly preferred

• Experience as an unblinded monitor required

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a requesthere.

Are you a current ICON Employee? Please click here to apply