Freelance Senior Clinical Research Associate

TFS HealthScience

21h•Remote

About The Position

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. We are currently building a network of experienced Freelance Senior Clinical Research Associates for an anticipated ophthalmology project. This role functions operationally as a member of a Project Team and is responsible for the initiation, on-site and/or remote monitoring and close out of study sites during study conduct, according to company policies, SOPs and regulatory requirements. The role provides Unmasked Clinical Research Associate support for assigned clinical studies, including management of investigational product accountability, oversight of unblinded site activities, and monitoring of protocol compliance in accordance with study requirements and applicable regulations. The role collaborates with study teams, investigative sites and sponsors to ensure timely execution of study deliverables while maintaining the integrity of study blinding and data quality.

Requirements

Bachelor’s Degree, preferably in life science or nursing; or equivalent
>5 years of independent on-site monitoring experience
at least 1 year experience as an unmasked monitor is required.
Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
Ability to work independently as well as in a team matrix organization.
Excellent written and verbal communication skills
Fluent in English and local language
Excellent organizational skills
Technology savvy and good software and computer skills
Soft skills requirements: Self-awareness, resolute, flexibility, collaborative mindset, proactivity, analytic approach, and attention to detail, coach ability, motivated to take on new challenges, facilitation of discussion, diplomacy in difficult situations.
Ability to take the ownership of the assigned tasks.
Ability to manage complex or early phases studies.

Nice To Haves

At least 1 year Ophthalmology, ideally within a retina indication (i.e. Age-related Macular Degeneration, Diabetic Macular Edema, Geographic Atrophy, RVO, BRVO, CRVO, etc.), experience is preferred.
Able to work in a fast-paced environment with changing priorities.
Ability and willingness to travel up to 60-80%, overnight and abroad, if applicable.

Responsibilities

Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations.
Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
Verify proper management and accountability of Investigational Product
Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
Timely delivering site documents to eTMF or paper TMF.
Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
Update CTMS and all other required by projects systems with accurate site level information
Participate in audit and/or inspection, it’s preparation and follow-up activities, as needed.
Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
May assist the Clinical Research Manager or Project Manager in certain aspects of project activities which may include: project tracking, monitoring plans, Review of monitoring reports CRA resources management within the project
May perform Assessment Site Visits (ASV) when requested.
May act as a mentor to CRAs.
May develop and implement therapeutic area training for other CRAs and project team members.
May participate in capabilities presentations.