Description:
Location: Poland - home-based

Schedule: Freelance - 0.5-0.7 FTE

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds....

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Freelance Clinical Research Associate to join our sponsor in Poland to conduct an asthma clinical study.

CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.

The Freelance will work closely with the Clinical Operations team in assisting with study sites and site activation, patient recruitment, study monitoring, case report form development, and study management. The CRA will interface with site coordinators, field clinical staff, and Clinical Research Organization. Experience monitoring respiratory studies is preferred.

Main Job Tasks and Responsibilities:

• Participates in planning, prioritizing, and executing all aspects of clinical trial.
• Participates in problem-solving and risk-mitigation strategies.
• Drafts and/or coordinates review of protocols, informed consents, case report forms, and monitoring plans
• Interfaces with individuals in other functional areas to address routine study issues.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Participates in departmental and corporate initiatives under general supervision.
• Performs co-monitoring visits to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits, as required.
• Reviews reports and metrics to ensure site compliance with the protocol and regulatory requirements.
• Generates and maintains reports, listings, and trackers as needed.
• Manages study vendors to ensure compliance with the protocol.
• Completes other responsibilities as assigned.

Education, Experience, and Skills:

• Minimum 5+ years of experience in a clinical research environment
• CRA with experience
• Polish and English shall be very good.
• Site monitoring experience at clinical sites is highly preferred.
• Working knowledge of GCP, ICH, and relevant CFRs is required.
• Ability to work independently and manage multiple projects with minimal supervision.
• Strong communication skills, both written and oral
• Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures.
• Ability and willingness to travel as/if necessary.
• Enjoy working in a fast-paced company.
• CRA will work mainly in Poland.

The Application Process

Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs please contact mailto:careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Clinical Research Associate, CRA, Pharma, CRO, Clinical Research Organisation, Clinical Trials, Clinical Monitoring, Freelance, Freelancer, Contractor, ICFs, GCP, CTMS, monitoring visits, Co-monitoring, Monitoring Reports, Close-out visits, PSV, pre-selection visit, SOP, ICH, FL, Contract, Temporary, Outsourced, Outsourcing, CTMS, Clinical Research
Skills: Clinical Research Associate Location: Poland