Clinical Study Coordinator

Job Summary

The Clinical Study Coordinator (CSC) works under the direction and guidance of Study Managers and Study Directors and performs duties as directed to support the quality completion of projects. The CSC participates during all phases of the project process under the guidance of senior Managers and reports to the Project Management Office Manager or designee.

• Schedule and conduct project meetings, including creation of agenda, notifying participants, acting as scribe, compiling meeting minutes, dispersing them, and following up on all action items.
• Create and file Sponsor Meeting Materials.
• Assist with writing startup plans and overseeing protocol compliance during studies.
• Review Investigator Brochures (IBs), Protocols, and data collection documents.
• Creating and reviewing study documents.
• Contribute to excellent communication and risk mitigation on each project by creating Data Reconciliation Plans and Protocol Deviation Logs for review by the Sponsor and Study/Project Manager.
• Identify and develop Training Package needs (including Study Specific Training (SST)) for review by the Study/Project Manager; identify internal colleagues who need to partner and provide training.
• Prepare subject recruitment training, SST slides, specialty training for study floor staff, and Site Initiation Visit (SIV) agenda, minutes, and action items.
• Create and update a comprehensive Risk Management exercise and Internal Kickoff Meeting to identify and mitigate study risks for all team members.
• Write Informed Consent Forms (ICFs) and develop associated training and performance needs such as the Highlighted ICF and Review of Content.
• Maintain accurate records of all protocol activities and events, sampling times, special test procedures, and adverse events, ensuring timely review according to the Data Reconciliation Plan.
• Manage monitoring activities.
• Follow the progress of volunteers and provide care, comfort, and safety by attending to their needs during study participation.
• Provide shift and weekend coverage for in-house studies and follow-up visits as needed; be available onsite the majority of the work week.
• Accept responsibility and be accountable for assigned and delegated activities.
• Align with the industry standard workload for Clinical Study Coordinators at Spaulding Clinical Research.
• Keep abreast of SOPs, Good Clinical Practice (GCP), ICH Guidelines, state and national laws, and ethical standards; search out additional training as needed or required.
• Maintain professional working relationships with Sponsor representatives and internal colleagues within Spaulding Clinical Research.

The statements made in this job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job.

• Ability to read, write, and interpret the English language.
• Demonstrated ability to lead by example and encourage team members to seek solutions.
• Excellent planning, organizational, and time management skills.
• Excellent oral, written, and presentation skills.
• Strong analytical and problem‑solving skills.
• Strong written and verbal communication skills.
• Detail oriented with good organizational traits.
• Self‑motivated and results oriented.
• Multi‑tasking, quick learner, responsive to urgent needs, and a strong track record of meeting deadlines.
• Good computer skills and inclination to adopt technology to maximize efficiency.

• 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: clarity of vision both near and far.
• Ability to identify and distinguish colors.

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

• Accredited college or university degree.
• Minimum of one (1) year of clinical research experience as a Clinical Study Coordinator, Clinical Research Associate, Clinical Manager, or similar role; or two (2) years of Phase I clinical research experience.
• BLS certification required within first year of hire/promotion.
• ACLS certification required within first year of hire/promotion.
• Demonstrated knowledge of Good Clinical Practice (GCP) and applicable regulatory requirements.
• Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education that may vary from the above listed skills and qualifications.