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Job Summary: 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.

Calendar and Meeting Management/Attendance

• 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

Clinical Trial Systems and Documentation Support

• 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.

CAPA and Deadline Tracking

• 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.

Quality Control

• 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

Communication and Coordination

• 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.

The statements contained in this job description are intended to describe the general nature and level of work being performed by employees assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties, qualifications, or skills required.

Employees may be assigned additional duties, responsibilities, projects, or tasks as necessary to support departmental and organizational objectives. Such duties may not be specifically listed in this job description but will be reasonably related to the position and business needs of the Company.

Management reserves the right to modify, interpret, add to, remove, or reassign duties and responsibilities at any time, with or without notice, based on operational needs.

This job description does not constitute a contract of employment and should not be construed as a guarantee of employment for any specific duration.

Skills / Qualifications

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Key Competencies

• Highly organized and proactive.
• Able to anticipate DMSO needs and remove administrative friction.
• Comfortable working in a fast-paced clinical research environment.
• Strong follow-through and deadline management.
• Excellent discretion and confidentiality.
• Clear communicator with strong documentation skills.
• Able to distinguish urgent safety/compliance items from routine administrative matters.
• Collaborative, service-oriented, and operationally minded.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Ability to lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include clarity of vision both near and far.
• Ability to identify and distinguish colors.

Hazards:

• Potential for exposure to toxic or caustic chemicals
• Potential for exposure to blood borne pathogens

Education and Experience:

• High School Diploma required. Bachelor's Degree preferred.
• 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.

Spaulding Clinical management reserves the discretion to consider equivalent combinations of education, experience, knowledge, skills, and abilities in lieu of the qualifications listed above.