Description:
Title: Lead Clinical Research Associate

Location: Pennsylvania

Schedule: Full-time

CROMSOURCE is looking for a Lead Clinical Research Associate to join one of our partner companies - a small Medical Device company, based in Pennsylvania.

The Lead Clinical Research Associate will oversee the site management aspects of designed projects, including managing monitoring activities and liaising with project management to ensure that the deliverables are met.

The successful candidate will be working on studies dedicated to one client.

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 who will work closely with you to support your professional development and growth.

Main Responsibilities and Accountabilities:

• Liaise with and manage study operations and the vendor/CRO's activities, including project timelines and deliverables.
• Assess vendor/CRO performance and provide guidance
• Contribute to relevant study documentation development including clinical protocol, study operational plans and case report forms
• Participate in the selection of investigational sites
• Review and analyse study data
• Oversee clinical trial quality and compliance through review of monitoring reports, audit reports, communications with investigators, and study site and vendor personnel.
• Oversee maintenance of the Trial Master File (TMF)
• Identify and find solutions to Regulatory issues and risks
• Provide or facilitate training to clinical study teams
• Provide input into non-project related activities and development of departmental processes, procedures and guidelines as requested
• Support other study activities as required to ensure that the deliverables are met

Minimum Work Experience

• Significant experience within Clinical Research, including experience as a Lead Clinical Research Associate or similar.
• Experience with Medical Device studies
• Prior experience managing CROs and/or vendors

Skills

• Knowledge of ICH-GCP, FDA and Health Canada guidelines and regulatory requirements
• Excellent interpersonal, site management, relationship building, verbal and written communication skills including excellent presentation skills.
• Client focused approach to work
• A flexible and adaptable attitude and ability to work in a fast-paced environment
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
• Value the importance of teamwork.
• IT literate.
• Sense of urgency in completing assigned tasks.

Education

• Educated to degree level (biological science, pharmacy or other health related discipline preferred) or equivalent nursing qualification/experience.

Language Skills

• Competent in written and oral English and local language.

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 location is 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 regarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

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.

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

Keywords: Lead Clinical Research Associate, LCRA, Principal Clinical Research Associate, PCRA, Junior Project Manager, Clinical Operations Associate, Contract Research Organisation, CRO, Outsourced, Pharmaco, Pharmaceutical, Medical Device

Skills: Lead CRA Location: United States Share:

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