Clinical Research Study Manager

A Study Manager I is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines.

DUTIES & RESPONSIBILITIES                                                                                   

• Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner. 
• Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation. 
• Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines. 
• Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). 
• Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents. 
• Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
• Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s). 
• Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s) 
• Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner.         
• Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site. 
• Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned. 
• Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). 
• Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial.
• Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives 
• Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent 
• Facilitate effective communication between patients, healthcare providers, and research staff
• Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives 
• Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent 
• Facilitate effective communication between patients, healthcare providers, and research staff

KNOWLEDGE & EXPERIENCE

Education:

• High School Diploma or equivalent required
• Bachelor's degree preferred
• Foreign Medical Graduates preferred 

Experience:

• Minimum of 5 years experience in Clinical Research (Senior Lead CRC)
• Supervisory experience preferred
• Wide therapeutic range of clinical trials experience preferred
• Regulatory research experience is a plus

Credentials:

• ACRP or equivalent certification is preferred 

Knowledge and Skills:

• Goals-driven while continuously maintaining quality.
• Must be detailed-oriented, proactive, and able to take initiative.
• Must have strong written and communication skills.
• Must have excellent customer service skills.
• Proficient communication and comprehension skills both verbal and written in the English language are required. 
• Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred

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