Study Manager I

A Study Manager 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 and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis.

DUTIES & RESPONSIBILITIES

• Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis.
• Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
• Adherence and compliance to the assigned protocols at their respective site(s).
• Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to
• Sponsor-provided and IRB-approved Protocol Training
• All relevant Protocol Amendments Training
• Any study-specific Manuals Training as applicable
• 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).
• Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols 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.
• 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).
• 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.
• 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.
• 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).
• Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s).
• Being prepared for and available at all required company meetings.
• Submitting required administrative paperwork per company timelines.
• Occasionally attending out-of-town Investigator Meetings.
• 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
• Any other matters as assigned by management.

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
• 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