Description:
Job Title: Senior Clinical Research Associate

Location: United States

Schedule: Full Time - 1.00 FTE - Homebased

TalentSource Life Sciences is searching for an experienced freelance Senior Clinical Research Associate in the US to conduct oversight and monitoring activities. This will be covering 2 sites, with approximately 75% travel expected. The anticipated start for this role will be October 2019.

The successful candidate will be working on studies dedicated to one client , a Medical Technology company. As a client-facing role, we are looking for confident candidates with strong site management skills and the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

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 TalentSource Line Manager.

Responsibilities:

• Ensure compliance to the study protocol and Monitoring Plan.
• Assist in the site qualification visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigational sites.
• Perform training of site staff in all study procedures in order to ensure protocol/ICH-GCP compliance.
• Conduct and report periodic monitoring visits in the field and reviews at each visit the accuracy, legibility, completeness and quality of Case Report Forms (CRFs) in compliance with the protocol, SOPs and ICH-GCP requirements in order to ensure data integrity and subject safety.
• In cooperation with the site staff, ensure proper reporting is completed by the site for safety issues (adverse events and adverse reactions) and their follow up, guaranteeing timely and appropriate handling of safety issues.
• Support with the submission process for the project (or region), including preparation and submissions to the Ethics Committee.
• Travel expected for up to 75%.

Education/Qualifications:

• BSc in Life Sciences, nursing degree or equivalent.

Experience, Skills, Knowledge

• Strong monitoring and submissions experience is essential
• Experience monitoring at private practices
• Previous experience working on Dental studies and/or Medical Device studies
• Up to date knowledge of ICH-GCP
• Ability to learn and apply SOPs and other current regulations
• Excellent inter-personal skills and the ability to persuade others
• Strong written and verbal communication skills
• Willingness to travel as required

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001929

If you would like to discuss the role before applying through the website, please contact holly.price@cromsource.com for more information.

Why TalentSource Life Sciences/CROMSOURCE:

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 independent, international Contract Research Organization (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunity 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.

How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor.

Keywords: CRA, SCRA, Clinical Research Associate, Clinical, CRO, Pharmaceutical, Monitor, GCP, Medical Device, Dental, Private Practice, Medical Technology, Freelance, Contractor, Contract, Temporary, Contract Research Organization, Pharma
Skills: Clinical Research Associate, Senior Clinical Research Associate, GCP, Medical Device, Monitoring, Pharmaceutical Location: United States