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Coordinador de Estudios (Study Coordinator)

**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. **FUNCTIONS:** The Study Coordinator is responsible for the protocol activities of LaRed at an assigned site. Although the safety and well\-being of the study participant are ultimately the responsibility of the PI, the SC must work closely with the center's PI to ensure the subjects' well\-being. The SC carries out activities related to the protocol, specifically assigned in accordance with the protocol, institutional policies, Good Clinical Practices (GCP) and the relevant regulatory requirements. **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. * Coordinate the selection of study subjects at the assigned site: * Identify and recruit appropriate subjects from the study population (also referred to as the selection process for possible study subjects) while adhering at all times to the GCP guidelines. * Develop and maintain relevant Standard Operating Procedures (SOPs), study tools, checklists, logs, and other procedural documents specific to the assigned site’s study subject selection processes. * Manage and properly document any financial reimbursement to the subjects. * 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: + Obtain the appropriate informed consent with the corresponding documentation from the study subject or legal guardian. + Select, recruit and retain study subjects. + Schedule subject visits and related clinical activities per protocol. + Track subjects as required by the protocol. + 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. + Evaluate the subject's safety during their entire participation in the study, and monitor subjects for AEs and UAPs as appropriate. + Communicate any concerns regarding the subject's rights, privacy, or welfare to the PI as soon as concerns arise. + Consult with the PI regarding questions about the interpretation of the protocol, any related documents, subject source documents, and the CRF/eCRF. * 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 administrators/management, laboratories, and pharmacies * Participate in any relevant or assigned LaRed teleconferences and web meetings as necessary, e.g. study\-specific site calls and training refresher webinars. * Coordinate site audit preparedness and quality improvement efforts: + Collaborate with the PI, other site staff, and LaRed\-CC to design and implement quality management goals and plans for studies When the assigned site does not have an active study: * Coordinate quality control reviews of all site documents across all studies; identify errors and trends, make corrections, and recommend corrective actions as appropriate. * Review site staff and investigators to identify any knowledge gaps in research\-related training and practice; make recommendations for training and re\-education and spearhead these efforts as appropriate. * Investigate certifications, supplies, resources, and equipment that could improve site capacity for future research; collaborate with the investigators and LaRed\-CC to determine feasibility and implementation. * Conduct site assessments, staff evaluations, and mock audits as designated by the PI * Participate in all assigned training(s) deemed by the LaRed/LaRed\-CC * SC may be temporarily assigned to support other sites in a nearby geographic area, as agreed to by the SC, PI, and LaRed\-CC in order to cover other sites’ needs. **SKILLS AND EXPERIENCE:** * The SC must be a doctor or nurse with experience in clinical research. * Familiarity with applicable international, US, and Indonesian regulations and guidelines pertaining to clinical research, including ICH\- E6 Good Clinical Practice Guidelines * Ability to coordinate complex systems for research quality control. * Excellent organizational and time management skills. * Ability to keep detailed and accurate records. * Very strong interpersonal skills, flexibility and strong written and verbal fluency in Spanish and English. * Strong written and verbal communication skills. * Prior clinical research experience as a study coordinator, investigator, research nurse, clinical research associate/monitor or similar is strongly preferred.

Mexico