Location: United Kingdom - home based
Schedule: Full-Time, Permanent
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 Lead Clinical Research Associate to join one of our partner companies.
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 the client counter-parts.
Scope of the role:
The Lead Clinical Research Associate will work closely with the Clinical Operations team in assisting with study site and country selection, site activation, patient recruitment, study monitoring, case report form development and study management. The person in this position will interface with site coordinators, field clinical staff, Clinical Research Organizations (CRO), and other company representatives.
Main Job Tasks and Responsibilities:
- Participate in planning, prioritizing, and executing all aspects of Phase 1-4 clinical trials
- Participate in problem-solving and risk mitigation strategies
- Drafts and/or coordinates review of protocols, informed consents, case report forms and monitoring plans
- Regulatory package and ICF review
- Interface with individuals in other functional areas to address routine study issues
- Ability to develop tools and processes that increase measured efficiencies of the project
- Assist in CRO or vendor selection
- Provide CRO / vendor oversight
- Participate in departmental and corporate initiatives under general supervision
- Perform co-monitoring visits to provide oversight during site qualification, site initiation, routine monitoring and close-out visits, as required
- Review reports and metrics to ensure site compliance with the protocol and regulatory requirements
- Generate and maintain reports, listings, and trackers as needed
- Manage and QC eTMF(s) for supporting study(ies)
- Manage study vendors to ensure compliance with the protocol
- Complete other responsibilities as assigned
Education and Experience:
- Bachelor's degree in life sciences or equivalent experience
- Minimum 3+ years of experience in a clinical research environment
- Site monitoring experience at clinical sites is required, in addition to submissions and start-up activities
- Experience overseeing CRAs, CROs and Vendor's
- Working knowledge of GCP, ICH and relevant CFRs is required
- Ability to work independently and manage multiple projects with minimal supervision
Specific Role Requirements and Skills:
- 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
- The activity is remote with little to no travel (a co-monitoring visit or direct visit to investigator site if required)
- Enjoy working in a fast-paced, small-company, virtual environment
The Benefits of Working for TalentSource in the UK:
- Pension contribution
- Life assurance
- 25 days holiday
- Child care vouchers
- Eye test vouchers
- Seniority bonus
- Car allowance for defined roles
- Dedicated Line Manager
- Monthly meetings with line manager
- Full performance and development process with end of year reviews
- Team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for 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 firstname.lastname@example.org for more information.
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, 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.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
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 the 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 in relation to 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: Lead Clinical Research Associate, Principal Clinical Research Associate, Senior Clinical Research Associate, Clinical Research Associate, Clinical Trial, Project Management, Pharma, Pharmaceutical, Monitoring, GCP, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicated
Senior Clinical Research Associate, clinical trials, CRO, GCP, Project Management