CTA
- Employer
- ICON Plc
- Location
- Poland
- Salary
- Competitive
- Start date
- 17 Jul 2024
- Closing date
- 27 Jul 2024
View more
- Discipline
- Clinical Research, Clinical Trials Manager / Administrator
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
ESSE N T IAL D U TI E S A N D RE S PONSIBIL I TI E S
o P r o a c t i ve co m m u ni cati o n w i t h cl i n i cal service pr o v i d e r s
o R ev i ew of a l l h o m ec a r e d o cumen t a t i on i n a ccor d a n ce w i t h G C P a n d s t u d y sp e c i f i c
r e q u i r eme n t s wi t h i n t a r g et t urn a r o u nd t i m e fr a m e s
o C o o r d i n a t i on of r es p o n s es f r om c li n i cal service p r ov i d e r s t o q u eri e s
o M a i nta i n D o c u m e n t s a n d S t u d y F i l es, i n a ccordance wi t h G C P a n d s t u d y sp e c i f i c
r e q u i r eme n t s
o A ss i st wi t h a u d i t s to ensure inspection readiness
o A ss i st wi t h standard metric r e p o rt i ng and distribution
To p erfo r m t h i s j o b su cc e ss fu l l y , a n i n d i vi d u a l m u s t b e a b l e t o p e r fo r m e a c h es s e n t i a l d u ty s at i s facto r il y . L i s t k n o w l e d g e , sk i l l s a n d/ o r a b i li t i es re q u i r e d. R e a s o n a b l e ac c o m m o d a t i o n s m a y b e m a de to e n a b l e i n di v i d u a l s w i th d i s a b i l i t i es to p e r form es s e nt i a l f u n c t i o n s .
- A dmi ni s tr ati o n , coordination , m a n a g e m e n t o f d el e g ated s t u d y a c t i v i t i e s
o P r o a c t i ve co m m u ni cati o n w i t h cl i n i cal service pr o v i d e r s
o R ev i ew of a l l h o m ec a r e d o cumen t a t i on i n a ccor d a n ce w i t h G C P a n d s t u d y sp e c i f i c
r e q u i r eme n t s wi t h i n t a r g et t urn a r o u nd t i m e fr a m e s
o C o o r d i n a t i on of r es p o n s es f r om c li n i cal service p r ov i d e r s t o q u eri e s
o M a i nta i n D o c u m e n t s a n d S t u d y F i l es, i n a ccordance wi t h G C P a n d s t u d y sp e c i f i c
r e q u i r eme n t s
o A ss i st wi t h a u d i t s to ensure inspection readiness
- Assist with Home Health Design, study conduct, and close-out procedures
o A ss i st wi t h standard metric r e p o rt i ng and distribution
- Keeping all internal stakeholders informed in a timely manner
- Ensure high satisfaction of all internal stakeholders
- Comply wi t h I CH/ G CP , IA T A , Data Privacy a n d oth e r a p p r o p r i ate r e g u l ati o ns
- Monitoring flow of incoming study documents
- Follow up with homecare providers for outstanding agency/clinician documents.
- Create and maintain internal files which may include clinician/ CSM documentation and ,and CRM data entry
- Ot h e r d u t i es as ass i g n ed
- Recording, filing, and tracking progress of order fulfillment
- Receipt and input of new and updated Physician Order Forms (POFs).
- Management of supply storage area
- Equipment and supplies inventory management and shipping
- Maintaining adequate shipping and ancillary supplies
- Ot h e r d u t i es as ass i g n ed
- QUA L IFICA T I O NS
To p erfo r m t h i s j o b su cc e ss fu l l y , a n i n d i vi d u a l m u s t b e a b l e t o p e r fo r m e a c h es s e n t i a l d u ty s at i s facto r il y . L i s t k n o w l e d g e , sk i l l s a n d/ o r a b i li t i es re q u i r e d. R e a s o n a b l e ac c o m m o d a t i o n s m a y b e m a de to e n a b l e i n di v i d u a l s w i th d i s a b i l i t i es to p e r form es s e nt i a l f u n c t i o n s .
- E xce ll e n t co m m u ni cati o n sk ill s ( w r it t en a n d v e r b al )
- We ll - organ i zed
- A b l e t o m u l t i - t ask
- A b l e t o w o r k i n d e p e n d e n t l y or as an e ff e c t i ve m e m b e r of a t e a m
- A tt e n t i on t o d e t a i l
- Decision making
- P r ofic i e n t comp u t er sk ill s, i nc l u di ng O u t l o o k, W or d, a n d E xcel
- A d h eres t o t i m e li n e s a n d d u e d a t es
- T a kes i ni t i ative w h il e f o l l o wi ng d i r ectiv e s
- Proactive
- C om m it t ed t o qua l i t y r e s u l t s
- Available to work from ICON Gdansk office
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