Regional CRA (Mid West)

Regional Clinical Research Associates

Direct-Hire

Mid-West

 

Metropolitan Research Associates (MRA) is a therapeutically focused Contract Research Organization (CRO) that offers Clinical Trials Management Services and Functional Pharmacovigilance Services. MRA has been an established CRO since 1995 and has a very experienced team providing these services to the pharmaceutical industry.

 Description Summary: The CRA will be responsible for performing and coordinating all aspects of clinical monitoring in compliance with FDA regulations, ICH/GCP guidelines and the company SOPs.  The CRA will conduct site visits to determine protocol and regulatory compliance. Essential Functions: Willingness to travel 50-70% Conducts site visits as required pre-study, initiation, interim monitoring and close-out visits to ensure compliance with protocol and ICH/GCP guidelines Monitors investigational product accountability Conducts regulatory document review at the sites and MRA Facilitate effective communication between investigative sites, Sponsor and MRA project team Maintains a working knowledge of protocol related specifics in order to serve as a resource to the investigative sites Site management - Performs administrative duties such as attendance at project team meetings, protocol related training sessions. Prepare, process and track regulatory documents for study start-up. Assist in the creation of the study source document and case report form completion guidelines, ensuring their correspondence to the Case Report Form and Study Protocol. Informed Consent Form review for adherence to study protocol and IRB requirements. Work closely with sites to reconcile data clarification forms within a short period of time prior to data locks. Review edit check listings, generate and reconcile queries to ensure accuracy of the data. Update enrollment tracking and generate enrollment reports. Participate in team meetings, write and distribute meeting minutes. Audit in house regulatory file 

Education and Experience:

 BA/BS in a life science or related field Minimum 2+ years Field Monitoring experience with a CRO, Pharmaceutical or Biotech company 

Skills & Knowledge:

 Excellent clinical trials monitoring skills Strong computer skills Solid understanding of ICH/GCP guidelines Strong verbal and communication skills Effective self management and organizational skills Effective oral and written communication skills with the ability to communicate effectively with medical personnel Strong customer focus and excellent interpersonal skills Ability to prioritize work in order to meet demanding timelines Ability to utilize problem-solving techniques applicable to constantly changing environment 

We offer a very competitive salary and benefit packages. For more information about MRA and our career opportunities, visit us online at www.metropolitanresearch.com . You may also submit your resume/cv via email to bhardy@metropolitanresearch.com .