Site Coordinator

About the role

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.

Responsibilities

• 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.
• Affixes with obtaining the required assessments at each visit per the protocol and notifies the investigator of any critical values that need immediate attention or would prohibit or delay study treatment.
• Affixes with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual.
• Affixes with scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution.
• Tracks 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.
• Affixes 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.
• Supports proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintains the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding.
• Affixes with maintaining appropriate temperature monitoring for study products and supplies.
• Supports the contract and budget negotiations and oversees Investigator/Site Payments.
• Ensures 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 protocol 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 participates in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections.
• Assists with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs).
• Might be involved in the on-site training of additional staff as part of the SEO or other education programs.
• Affixes with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements.
• Maintains 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.

Qualifications

• Education: Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects.
• Certifications: - Current Good Clinical Practice (GCP) - International Air Transport Association (IATA) - Current Basic Cardiopulmonary Resuscitation (CPR) - Phlebotomy certification unless part of active professional licensure (RN or LPN) - Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified.