Clinical Research Coordinator

Gastro Health is seeking a Full-Time Clinical Research Coordinator to join our team!

Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours.

This role offers:

• A great work/life balance
• No weekends or evenings – Monday thru Friday
• Paid holidays and paid time off
• Rapidity growing team with opportunities for advancement
• Competitive compensation
• Benefits package

Duties you will be responsible for:General Administrative

• 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.

Protocol Preparation & Review

• 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.

Conduct of Research

• 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.

Project Closeout

• 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.

Minimum RequirementsEducation/Training (or equivalent): H.S. Diploma College Degree Certification/License *desirable

• Bachelor's Degree, preferred

• BLS certification, preferred
• Certification via SOCRA and/or ACRP, preferred
• Good Clinical Practice (GCP) Certified, preferred
• IATA-Dangerous Goods Certified, preferred

Experience (Type of work experience, min. number of years):

•  2-5 years of Clinical Research experience required

• 1-2 years of experience utilizing a CTMS, EDC, IWRS/IXRS, EHR

Technical or Administrative Knowledge:

• Prior knowledge of clinical trials, as well as ICH-GCP principles, preferred
• Facilitation of Close-Out, Site Initiation, and Monitoring visits as required/needed
• Knowledge of Protocol Deviations, Serious Adverse Events, and Safety Reports
• Knowledge of Protocol review including Inclusion/Exclusion and Study Assessments

Required Skills and Abilities and/or:

• Availability to travel as required for training sessions
• Skills in Phlebotomy/Venipuncture
• Willingness to learn how to operate/conduct and ECG/EKG Machine
• Ability to provide shadow support to entry-level research personnel
• Familiarity with medical terminology
• Self-starter capable of working independently.
• Ability to thrive in a fast-paced, high-pressure environment
• Desire to train and develop skills

Gastro Health is the one of the largest gastroenterology multi-specialty groups in the United States, with over 130+ locations throughout the country. Our team is composed of the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees.

Gastro Health is proud to be an Equal Opportunity Employer. We do not discriminate based on race, color, gender, disability, protected veteran, military status, religion, age, creed, national origin, gender identity, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.

We thank you for your interest in joining our growing Gastro Health team!