MEDICAL OPERATIONS COORDINATOR

SPAULDING CLINICAL RESEARCH LLC•West Bend, WI

7d•$26 - $31•Onsite

About The Position

The Medical Operations Coordinator provides dedicated administrative, operational, and clinical workflow support to the Director of Medical Strategy and Oversight (DMSO). This role is designed to help the DMSO remain organized, responsive, and on track with clinical trial responsibilities, including adverse event workflows, email follow-up, calendar management, documentation support, dictation assistance, and deadline tracking for CAPAs and other required study activities. This position is embedded in medical operations and requires a high level of discretion, organization, attention to detail, and familiarity with clinical research workflows. The role is a DMSO-focused clinical support role intended to improve responsiveness, documentation accuracy, and timely completion of investigator responsibilities.

Requirements

Experience in clinical research, clinical operations, healthcare administration, medical office support, or executive-level administrative support.
Strong organizational and follow-up skills with the ability to manage multiple competing priorities.
Excellent written and verbal communication skills.
High attention to detail and ability to work with sensitive or regulated information.
Comfortable learning and working within clinical trial systems, electronic records, and workflow management tools.
Ability to work closely with physicians, investigators, clinical research staff, quality teams, and operational leaders.
Strong judgment, discretion, and professionalism.
High School Diploma required.
Minimum of two years of experience in an administrative support role, clinical coordinator role, or similar position.
Experience working in an office setting and with other business professionals.

Nice To Haves

Prior experience supporting a Principal Investigator, physician, medical director, or clinical research leader.
Familiarity with GCP, clinical trial documentation, adverse event reporting, CAPAs, protocol deviations, or regulatory workflows.
Experience using ClinSpark or similar clinical trial management/eSource systems.
Experience in a Phase I clinical research environment.
Prior experience tracking deadlines, action items, quality documentation, or compliance-related deliverables.
Bachelor’s Degree preferred.

Responsibilities

Provide direct daily support to the Principal Investigator to help manage competing priorities, deadlines, and clinical trial obligations.
Help organize and prioritize the DMSO’s email inbox, including identifying urgent study-related communications and preparing draft responses when appropriate.
Assist with dictation, transcription, and drafting of DMSO responses, notes, and follow-up communications.
Track outstanding DMSO action items and ensure timely completion.
Help keep the DMSO on task during the day by monitoring meetings, deadlines, follow-ups, and required documentation.
Ensuring that the Recruitment Tracker is updated in a timely manner and transcribe MedOps determination for eligibility.
Provides real time instruction on behalf of DMSO for study specific questions that arise and sends follow-up email as required.
Manage and coordinate the DMSO’s calendar, including internal meetings, sponsor/CRO meetings, study-related reviews, and deadline-driven activities.
Prepare the DMSO for upcoming meetings by organizing relevant materials, agendas, and open action items.
Track follow-up items from meetings and ensure they are routed to the appropriate team members.
Coordinate with clinical operations, regulatory, quality, and site staff to support efficient scheduling and communication.
Setup MedOps Study Calendar according to study protocol procedures and study timelines.
Attend client meetings, SIVs, as needed.
Open, initiate, or help prepare adverse event records in ClinSpark under the direction of the DMSO and in accordance with site procedures.
Support documentation workflows related to adverse events, protocol deviations, CAPAs, queries, and other investigator responsibilities.
Track pending documentation, open items, and required DMSO reviews or signatures including, but not limited to protocols, informed consent forms, and study budgets.
Ensure documentation support is timely, accurate, and aligned with applicable SOPs, GCP, and regulatory expectations.
Reviews Delegation of Authority (DOA) and training logs to ensure completion, as needed.
Maintain tracking tools for CAPAs, quality issues, protocol deviations, and other time-sensitive DMSO responsibilities.
Monitor due dates and escalate approaching or overdue items.
Help gather supporting information needed for CAPA responses, investigation summaries, and follow-up documentation.
Coordinate with Quality Assurance, Clinical Operations, Regulatory, and other stakeholders to ensure DMSO-related deliverables are completed on time.
Review data for accuracy, consistency and completion.
Review participant charts for eligibility and consistency.
Ensures all internal and external medical records have been received and data input into participant charts prior to eligibility determination, admission and/or new records while on-study.
Serve as a key liaison between the DMSO and internal teams to ensure timely communication and follow-through.
Draft, organize, and route communications for DMSO review and approval (internal and sponsor), and send communications on behalf of the DMSO, as requested.
Help ensure that urgent clinical, safety, quality, or operational matters are brought to the DMSO’s attention promptly.
Maintain confidentiality when handling sensitive participant, study, sponsor, employee, or company information.
Follow-up with participants, as needed by DMSO.