Job Description

Clinical Research Coordinator

**candidates should have site-side, patient-facing clinical research experience**

Need exp with not only all the data and documentation, but they need to have worked in a clinical research environment where patients/participants are coming on-site for studies.

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Mon-Fri - start time can be between 7-9a

The research study is for liquid biopsies to determine GI Cancer

Works with study patients, pharmaceutical companies

Must have clinical research or clinical trials exp

Responsible for Research Assistant's

Soft skills such as attitude, flexibility and willingness to assist co-workers are just as important as required skills.

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The Clinical Research Coordinator provides assistance to the Research Department, including recruitment, managing data, and collecting, processing, and coordinating samples, specimens, and information.

DUTIES AND RESPONSIBILITIES:

• Provide assistance to Research staff by organizing files, projects, information and data.

• Collect, process, and assist in the compilation and verification of research data, samples, and/or specimens (following strict protocol and detailed instructions)

• Enter data from forms and documents into databases and other documents

• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol

• Become familiar with Research SOPs and study protocols

• Ensure patient’s referring physician receives notification of patient’s participation in studies as requested by the patient

• Collect, process, and ship blood/urine/stool specimens at patient visits

• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

• Submit patient stipends/reimbursement requests at the conclusion of study visits

• Ensure the filing and maintenance of all regulatory documents

• Maintain temperature logs

• Order and distribute dry ice as needed

• Periodically check expiration dates on clinical supplies and re-order as needed

• Assist coordinators with preparation of source documents

• Assist with subject recruitment by performing chart reviews, cold calling, etc.

• Schedule patient visits

• Process Lab specimens

• Assist with vital signs

• Perform Fibroscans once trained

• Phlebotomy

• Provide general office support to keep operations running smoothly

• Other duties as assigned

EDUCATION & EXPERIENCE:

• Completion of bachelor’s degree (in lieu of degree four years of relevant clinical research experience may be accepted)

• Minimum two years of experience in a related healthcare position

• Previous experience with clinical trials a must

• Experience with pharmaceutical trials preferred

QUALIFICATIONS & REQUIREMENTS:

• Able to effectively present information and respond to questions from physicians, staff and patients

• Proficiency in Microsoft Office software preferred, knowledge of EMR systems required

• Able to function effectively in a team setting

• Must have critical thinking skills

• Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals

• Able to demonstrate consistent professional conduct and meticulous attention to detail

• Completion of Good Clinical Practice and IATA training required

• Must be able to work flexible hours as necessary

• Previous phlebotomy experience preferred

• Must be a self-starter and demonstrate initiative

• Willingness to learn is a must

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