Job expirat
As Clinical Research Associate you will be responsible for performing routine site visits to ensure that the rights and well being of human subjects are protected; the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the trial is in accordance with all applicable regulatory requirements. In doing this, the Clinical Research Associate represents the company with professionalism and integrity.
Major Responsibilities
• Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Performs responsibilities with minimal support from management. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.
• Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
• Report any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.
• Maintain eClinical or alternative project tracking system of subject and site information.
• Perform other duties as assigned.
Requirements:
• Bachelor’s level degree in life sciences, pharmacy, nursing or RN preferred
• Previous clinical monitoring experience gained within the pharmaceutical clinical research environment
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Ability to work independently in a fast-paced environment
• Strong communication, interpersonal, and organizational skills
• Must demonstrate good computer skills
• Position requires travel
ADECCO RESURSE UMANE SRL
Romania, Bucuresti, sector 1, str. Dr. Iacob Felix Nr. 28, Etaj 4
Nr. ORCB J40/12364/2003, CUI RO15739037
Capital social subscris si varsat: 392.440 Lei
Nr. autorizatie Agent de Munca Temporara: 17/2005
Autorizatie seria nr. B/ 0000008/25.10.2005
Nr. Operator Date Personale: 15866
Tel: 00 40 21 300 35 46, Fax: 00 40 21 300 35 54
E-mail: office@adecco.ro, Web: www.adecco.ro
ADECCO ROMANIA SRL
Romania, Bucuresti, sector 1, str. Dr. Iacob Felix Nr. 28, Etaj 3
Nr. ORCB J40/4467/2000, CUI RO 13002186
Capital social subscris si varsat: 360.575 Lei
Nr. Operator Date Personale: 15862
Tel: 00 40 21 300 35 46, Fax: 00 40 21 300 35 54
E-mail: office@adecco.ro, Web: www.adecco.ro
BUCURESTI (HQ)- Doctor Iacob Felix Nr. 28, Sector 1, Tel.: 021/300 35 46; e-mail: recrutare@adecco.ro
ARAD - Mihai Eminescu nr. 45, Tel: 0257 / 281 147; E-mail: arad@adecco.ro
BRASOV - Str Petru Rares Nr 10; Tel.: 0040 - 372/70.57.95; e-mail: brasov@adecco.ro
CLUJ - Str. Vasile Lupu Nr 36 , Tel: 0264/ 406 234; e-mail: cluj@adecco.ro
IASI - Bld. Tutora Nr. 4, bl. B4 scara D, Tel: 0232 / 206 120; e-mail: iasi@adecco.ro
ORADEA - Str. Tudor Vladimirescu Nr 26; Tel.: 0040 - 727 735 160 e-mail: oradea@adecco.ro
PITESTI - Str. Fratii Golesti Nr. 57, etaj 2; Tel: 0248 / 612 303; e-mail: pitesti@adecco.ro
PLOIESTI - Str Mercurului Nr 1, Tel: 0244/ 519 320; e-mail: ploiesti@adecco.ro
SIBIU - Str. Vasile Milea Nr 11, Ap 57, Tel: 0269 / 206 450; e-mail: sibiu@adecco.ro
TIMISOARA - Str. Popa Sapca Nr. 12 tel: 0256/ 432 211; e-mail: timisoara@adecco.ro
