Clinical Research Coordinator

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.

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.

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 patients referring physician receives notification of patients 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 patients 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 bachelors 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