**SUMMARY**:**The Study Coordinator (SC) successfully supports the site's Principal Investigator (PI) in the development, monitoring, implementation management, and closeout of assigned protocols in which LaRed currently participates, as well as other protocols that may be developed and implemented by LaRed in the future. The SC will support, facilitate and coordinate the daily clinical research study/studies activities and play a critical role in the conduct of the study. The SC will work closely with the PI, LaRed Coordinating Center (LaRed-CC), other participating site(s), sponsor(s) and other entities related to the clinical study.
**DUTIES AND RESPONSIBILITIES**:
Key duties and responsibilities may include, but are not limited to, the following:
- Acquire understanding and maintain thoroughly updated knowledge of LaRed protocols.
- Identify any concerns or risks before the start of a protocol, with the PI.
- Participate in all required training for initiation of studies and other topic(s) assigned.
- Participate in meetings related to studies.
- Work with the PI, site team, and LaRed-CC to develop and edit protocol documents for the assigned site, such as Informed Consent Forms (ICFs) Standard Operating Procedures (SOPs), Manuals of Operations (MOPs) and any other related to the specific study.
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, state, regulatory, and institutional polices, as well as relevant international policies when applicable.
- Execute and maintain up-to-date technical skills regarding the diagnosis and observation of infectious diseases, including molecular biology techniques, serology, and antigen testing.
- Assist with other study-related activities in accordance with regulations and GCPs.




- Assist the PI with preparation and submission of LaRed study documents before the relevant Ethics Committee and any other corresponding regulatory agencies, including new protocol submissions and related documents, progress reports, amendments and closing documents. Collaborate with LaRed Coordinating Center (LaRed-CC) as needed to successfully prepare and submit such documents.
- Maintain required records of study activity including but not limited to; case report forms, drug dispensation records or any other deemed regulatory form(s).
- Support Site Initiation and Interim Monitoring Visits as needed:
- Work with the site investigators, other staff, and LaRed-CC to comply with the initiation, implementation, and closeout requirements of the study.
- Track the site progress in compliance with any activation, interim, and closeout requirements of the site.
- Resolve all problems in a timely manner, including protocol/regulatory deviations and data discrepancies identified during monitoring visits.
- Assist in correcting any negative finding in a timely manner, as necessary.
- Report all adverse events (AEs) and unanticipated problems (UAPs) to the site PI; coordinate the reporting of AEs and UAPs to LaRed-CC, study sponsor, relevant Ethics Committee, and any other regulatory agencies, in compliance with GCP, international and national regulations, the study protocol, and LaRed procedures
- Coordinate the operations of research studies:




- Implement the study procedures according to clinical capacity and training.
- Ensure the collection, processing, and proper shipment of biological samples.
- Contact the laboratory, site PI and sponsor regarding laboratory issues or problems, as necessary.
- Collect and archive laboratory results, as necessary.
- Collect participant data in source documents, as necessary.
- Ensure the exhaustive and accurate extraction of data from source documents in Case Report Forms (CRF) or in Electronic Case Report Forms (eCRF).
- Ensure that data collection, data entry, and data queries and discrepancies are completed and addressed in a timely manner.
- Develop and maintain up-to-date SOPs and other procedural documents specific to the assigned site, as needed.
- Ensure the accuracy of clinical practices in protocol activities.
- Facilitate and coordinate the logistics of site
- and study-specific supplies and equipment assigned to the site in collaboration with the PI and LaRed-CC:
- Coordinate financial reporting and invoicing of study supplies.
- Identify and document the items requiring input or permissions from the site’s host institution.
- Ensure the proper documentation and permissions are executed for assets contributed/financed by the United States sponsor, in collaboration with LaRed-CC who coordinates the acquisition logistics of such items. Such assets may include but are not limited to: freezers, centrifuges, other laboratory equipment, computers, printers, rapid influenza tests, pregnancy tests, and various inputs for sampling.
- Maintain open communication with all site staff and with the LaRed collaborators, including:
- Site PI and
- LaRed-CC
- Support staff for the study, e.g. data administrato

📌 Coordinador de Estudios (Study Coordinator) (México)
🏢 Fhi Clinical
📍 México