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Job Summary

The Clinical Study Coordinator (CSC) works under the direction and guidance of, and with, 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.

Essential Duties and Responsibilities

Under the guidance and direction of the senior managers, the CSC is responsible for:

• Scheduling and conducting needed project meetings. This includes creation of agenda, notifying participants, acting as scribe, compiling meeting minutes and dispersing, and following up on all action items.
• Creation and filing of Sponsor Meeting Materials.
• Assisting with writing startup plans and overseeing protocol compliance during studies.
• Reviewing Investigator Brochures (IBs), Protocols, and data collection documents.
• Creation and review of study documents.
• Contributing 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.
• Identifying and creating Training Package needs (including Study Specific Training (SST)) for review by the Study/Project Manager; identifies internal colleagues who need to partner and provide training, including:
  • Subject Recruitment Training
  • SST Slides
  • Specialty Training for Study Floor Staff
  • Site Initiation Visit (SIV) agenda, minutes, and action items
• Creating and updating a comprehensive Risk Management exercise and Internal Kickoff Meeting to identify and mitigate study risks for all team members.
• Writing Informed Consent Forms (ICFs), creating training and performance needs associated with this task, such as the Highlighted ICF and Review of Content.
• Reviewing Investigator Brochures, Protocols, Case Report Forms (CRFs), and informed consent forms for a thorough understanding of the study drug and procedures.
• Maintaining accurate records of all protocol activities and events, sampling times, special test procedures, and adverse events, and ensuring these are reviewed timely according to the Data Reconciliation Plan.
• Managing monitoring activities.
• Following the progress of volunteers and providing for their care, comfort, and safety by attending to their needs during study participation.
• Providing shift and weekend coverage for in-house studies and follow-up visits, as needed. Must be available onsite the majority of the work week.
• Readily accepting responsibility and being accountable for assigned and delegated activities.
• It is expected that Clinical Study Coordinators at Spaulding Clinical Research align with the industry standard workload.
• Keeping abreast of SOPs, Good Clinical Practice (GCP) and ICH Guidelines, state and national laws, and ethical standards. Searches out additional training, as needed or required.
• Maintaining 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.

Skills/Qualifications

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

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

• 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 which may vary from the above listed skills and qualifications.