Clinical Research Coordinator

Duties: Responsible for efficient processing and quality check of all study documents.

Job Functions- Review and ensure accuracy and completeness of clinical study files- Organize documents and data in ETMF (electronic trial master file), CTMS (clinical trial management system) and ensure compliance with internal procedures.  May review clinical data for completeness for multiple clinical research trials- Collate new study materials, create study binders, patient recruitment materials, and arrange shipment of materials to clinical sites- Other incidental duties Level of Independence- Close and continuing supervision- Little or no authority to deviate from established procedures- Unusual questions are handed off to the supervisor to address and handle (as opposed to the employee continuing to have responsibility)- Events not covered by procedures/instructions are referred to supervisor for disposition (as opposed to the employee continuing to have responsibility)- Supervisor reviews progress and results for thoroughness

Skills:

Required Skills:

Experience with TMF/ETMF- minimum 2 years experience (Veeva highly preferred) Knowledge of IRB documents / clinical study documents Clinical Study experience Pharma / Med device experience

- Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery- Experience with Clinical Systems such as eTMF (electronic Trial Master File) and CTMS (Clinical Trial Management System) preferred.- Good written and verbal communication skills and interpersonal relationship skills- Ability to work in a fast paced environment- Knowledge and understanding of Edwards policies and SOP, and domestic medical device regulatory guidelines relevant to clinical study documentation- Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint- Good written and verbal communications skills- Good problem-solving skills- Ability to manage confidential information with discretion- Strict attention to detail- Ability to interact professionally with all organizational levels- Contacts are across the organization, and may include external contacts- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of  influence/control

Keywords:

Education: H.S. Diploma  with 2 years of previous related experience required. Bachelor's Degree preferred.

Skills and Experience:

Required Skills: 

CLINICAL RESEARCH

CLINICAL STUDY

CLINICAL SYSTEMS

CLINICAL TRIAL

DOCUMENTATION