Gastro Health · 5 hours ago
Clinical Research Coordinator
Framingham, MA
Contract
Onsite
New Grad, Entry LevelGastro Health is seeking a Full-Time Clinical Research Coordinator to join their team. The role involves coordinating clinical research activities, assisting in protocol preparation, and ensuring compliance with federal regulations while maintaining effective communication with stakeholders.
Health CareMedical
Responsibilities
Coordinates with Principal Investigator, local site, and Central Hub to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures
Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training
Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures
Cooperates with compliance and monitoring efforts related to sponsored program administration and respond to any audit findings and implement approved recommendations
Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors
Attends investigator meetings as required or requested by the PI
Collaborates with the Regulatory Specialist to prepare IRB and any other regulatory submission documents as required by the protocol
Prepares other study materials as requested necessary. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs
Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials
Reviews and comprehends the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections
Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log
Develops and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals
Conducts or participates in the informed consent process and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed
Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion
Registers each participant in CTMS to ensure billing of study procedures to the appropriate funding source
Coordinates participant tests and procedures
Collects data as required by the protocol. Assures timely completion of Source Documents
Maintains study timelines
Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Gastro Health Research Policy on Investigational Drug/Device Accountability
Completes study documentation and maintains study files in accordance with sponsor requirements and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms
Retains all study records in accordance with sponsor requirements and Gastro Health Research policies and procedures
Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study
Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management
Assists the Principal Investigator and Regulatory Specialist in submission of accurate and timely closeout documents to applicable federal agencies, and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures
Arranges secure storage of study documents that will be maintained according to Gastro Health Research policy or for the contracted length of time, whichever is longer
Qualification
Required
High School Diploma
Preferred
Clinical research experience preferred
Previous phlebotomy skills
Benefits
Paid holidays and paid time off
Competitive compensation
Benefits package
Company
Gastro Health
Gastro Health is a medical practice company that provides gastroenterology adult and pediatrics services.
Founded in 2006
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$100MKey Investors
PenfundOMERS Private EquityAudax Private Equity
2021-07-01Private Equity· $10M
2021-07-01Debt Financing· $90M
2021-05-19Secondary Market
Leadership Team
Lawrence Freni
Chief Financial Officer
Alan Oliver
Chief Operating Officer
Recent News
2024-04-07
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