Senior Clinical Research Associate

Lawrence Harvey

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Job ID :

7053


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

North America,--California,South San Francisco,


Key Skills :

clinical Research Medical Device


Salary :

Negotiable


Date Posted :

04 May, 2017



Company Name :

Lawrence Harvey


Location1 :

South San Francisco




Job Category :

Clinical Research Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 50%





Description

Sr. Clinical Research Associate

San Francisco Bay Area

Urgently looking for a Sr. Clinical Research Associate with experience working on Medical Device trial. The client is a seeking a professional who can participate in clinical research programs by assisting with the development of study protocols, case report forms, clinical reports; performing clinical on-site case support, site monitoring visits; and interfacing with site coordinators, Clinical Research Organizations (CRO), and other company representatives.



Essential Duties:

* Ensure that documentation from investigators and investigational sites meets FDA/ ICH GCP/ISO 14155 requirements.
* Assist in designing, planning, and implementing clinical research projects
* Assist in the design of study protocol, case report forms, informed consent for sound and thorough data to support the device through the approval process.
* Review study records including case report forms, consent forms, and other materials.
* Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements.
* Organize data in systematic manner to allow for efficient and accurate clinical reports.
* Perform site visits to ensure regulatory and study requirements are being fulfilled.
* Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols; including surgical case coverage.
* Assist in writing the clinical portion of Regulatory submissions.
* Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.
* May oversee the work of Clinical Research Associate I, II and Clinical Trials Assistant.
* Perform other clinical duties when requested.
* Computer proficiency in Microsoft Office required.
* Maintains trained status for, and complies with, all relevant aspects of the clients Quality Management System to ensure product quality and support regulatory compliance.
* Understands and adheres to the clients Quality Policy.
* Must be willing to travel up to 35 to 50% of time

Education & Experience:

* Bachelor's degree in a scientific or health care discipline preferred and /or training
* 5+ years' recent experience in the role of Clinical Research Associate
* Four to six years' experience in the medical device industry with involvement in clinical research activities preferred.
* Effective clinical monitoring skills
* Excellent understanding and demonstrated application of GCP and applicable SOPs
* Prior experience managing CRO's and study sites


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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