Manager of Clinical Site Operations (3190)

DM CLINICAL RESEARCH GROUP•Albuquerque, NM

1d•$100,000 - $120,000

About The Position

The Manager of Clinical Site Operations ensures study enrollment meets or exceeds Sponsors' expectations and company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Responsible for immediate supervision and managing clinical site performance of the assigned site staff It is the responsibility of the Manager of Clinical Site Operations to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow-up on the action items, at their respective sites. 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 protocol(s) at their respective site(s). Ensuring 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. Ensuring data quality, subject retention, and compliance, timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations Coaching, counseling, and disciplining the employees as applicable. To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards. Communicating and effective implementation of strategic goals from senior management to the site team. 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 staf

Requirements

Bachelor’s degree preferred
Advanced degree preferred
At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization.
Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail.
Critical Thinking
Active Listening
Reading Comprehension — Understanding written sentences and paragraphs in work-related documents.
Speaking and Writing to communicate effectively as appropriate for the needs of the audience.
Ability to multitask, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams.
Strong computer skills in relevant software and related clinical systems are required.
Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
Proficient communication and comprehension skills both verbal and written in the English language are required.

Nice To Haves

Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred.
Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

Responsibilities

Responsible for immediate supervision and managing clinical site performance of the assigned site staff
Make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study.
Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow-up on the action items, at their respective sites.
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 protocol(s) at their respective site(s).
Ensuring 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.
Ensuring data quality, subject retention, and compliance, timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations
Coaching, counseling, and disciplining the employees as applicable.
To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards.
Communicating and effective implementation of strategic goals from senior management to the site team.
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 staf