The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager.
In this job you will:
- Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution.
- Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time.
- Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria.
- Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff.
- Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed.
- Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or鈥痺ould prohibit or delay study treatment.
- Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual.
- Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution.
- Track patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments.
- Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions.
- Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding.
- Assist site staff with maintaining appropriate temperature monitoring for study products and supplies.
- Support the contract and budget negotiations鈥痑nd oversees Investigator/Site Payments.
- Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the鈥痯rotocol before site implementation.
- Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc.
- Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections.
- Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs).
- May be involved in the on-site training of additional staff as part of the SEO or other education programs.
- Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements.
- Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II.
- SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope.