Clinical Research Associate I/II

Clinical Research Associate I/II

Gaithersburg, MD

Direct-Hire

 

Our client, a company dedicated to advances in biotechnology and devoted to patient support, is seeking a Clinical Research Associate I/II for a direct-hire position in Gaithersburg, MD.

 

Responsibilities

 Under the direction of the Study Specialist, primary duties include implementation of monitoring and recruitment plans, design of CRF completion guidelines, identification of investigators and management of investigator sites. Track recruitment and oversee monitoring activities such as timely CRF collection, resolution of data queries, and timely reporting of SAEs. Provide appropriate and timely communication of essential information to the project teams. Provides assistance to facilitate timely selection of investigators and sites and recruitment of patients for clinical trials globally. Assists in the creation of sound strategies and best practices to effectively recruit, and retain patients, investigators and sites for clinical trials. Interacts with investigators, study site personnel, and vendor/CRO personnel. Performs pre-study, site initiation, routine and close-out monitoring visits to ensure compliance with the protocol, state/country laws, federal regulations and guidelines. Assists in the preparation of the draft protocol, draft CRFs, template informed consent, prepares or assists in preparation of the coordinators manual, pharmacy manual, source documents, and other documentation required for the conduct of the clinical trial. Assists in the resolution of issues regarding grant negotiations and placement of assessments at assigned investigational sites. Assists in the final selection of investigational sites. Collects, and reviews essential documents for study start-up and ensures documents remain current during the course of the trial. Maintains Company?s internal trial master file to ensure inspection readiness. Reviews clinical data in-house and communicates with study site personnel for resolve data queries. Orders clinical supplies for assigned studies, and maintains accurate records of drug accountability/compliance across the study(s).

 

Qualifications

 BA/BS or equivalent experience.  Minimum of 1 year(s) clinical research experience in on-site monitoring is required, or equivalent, with good track record in the management of clinical investigative sites. Must be detail oriented. Must possess excellent organizational, communication and interpersonal / people skills, good collaboration and negotiation skills, and the willingness / ability to work in a matrix environment. Ability / willingness to travel nationally and internationally. This person will be traveling 50% nationally to sites.

 

This client is also seeking a CRA II/III and CRA III, Medical Affairs Operations.

 

Metropolitan Research Associates is a full service CRO and clinical research staffing firm that offers expertise in all areas of clinical development for the pharmaceutical, biotech, and medical device industries.

 

We offer a very competitive salary and benefit packages. For more information about our job opportunities and MRA or to submit your resume, visit us at www.metropolitanresearch.com or fax to 919-510-7914.