Job description

• Responsible for the performance of the research study under the medical supervision of the Principal Investigator and the Research Manager.
• The research coordinator is responsible for the overall successful implementation and ongoing site management of the research studies.
• Actively recruits and screens eligible patients for research protocols as assigned. Assists and conducts Informed Consent process.
• Coordinates and implements enrollment and follow-up procedures to collect, data from patient charts, medical records, questionnaires, and other sources. Cross-trains as backup on other studies as assigned. Completes worksheets and source document forms.
• Performs all study lab processing including centrifuging, aliquoting, storage, freezer maintenance and shipping as assigned.
• Assures that study-related laboratory tests and diagnostic procedures are completed, reviewed, and confirmed when necessary. Completes grading of labs per CTCAE V5.0 toxicity table and/or other study specific grading scales.
• Completes Case Report Forms/Source Templates and pertinent study-related forms accurately and within specified time limits. Resolves any CRF comments, errors, queries and delinquencies that come up with strict time-frames. Completes quality assurance assignments in preparation for Site Monitoring Visits.
• Communicates with providers, protocol teams, sponsors, as well as others from the research team regarding the clinical management of signs, symptoms, toxicities, abnormal labs, deviations, adverse events, etc.
• Maintains contact with study patients to facilitate study retention and their care, including communication regarding study requirements, coordinates drug dispensing, and other procedures, treatment, etc.
• Understands GCP, IATA and FDA requirements, ensuring compliance with regulatory agencies. Maintains patient charts as assigned.
• Maintains patient schedules as assigned.
• Attends pertinent educational or study activities and reviews current literature relevant to clinical trials assigned.
• Attends weekly team meetings.

IDEAL CANDIDATE:

• Works independently with little supervision to coordinate and oversee the activities of the assigned protocols.

QUALIFICATIONS:

• a minimum of one year oncology or clinical research experience;
• Electronic Health Records experience.
• Candidates must have strong written and oral communication skills,
• Must have the ability to work well under the pressure of meeting mandatory deadlines.
• Must have good organizations skills and careful attention to details.
• Must have ability to plan, organize and coordinate multiple work assignments simultaneously, while maintaining proficiency and efficiency.
• Need to have the ability to read, write, interpret and apply instructions to assigned activities.
• Experience in the use of office equipment.
• Experience working with computers and MS Office software environment.
• Valid Driver’s License, in state of residency, for travel to clinics.

WORKING ENVIRONMENT/LOCATION:  

• This position is performed in one (1) - two (2) administrative offices and one (1) clinic located in Lake County;
• Occasional local travel may also be required to vendors (i.e. dry ice, samples from hospital, disks from imaging center, etc);
• Ability to work in an upright and/or stationary position;
• Repetitive movement of extremities with the ability to make fast, simple, repeated movements of the feet, legs, fingers, hands, and wrists;
• Light lifting and carrying (or otherwise moves) objects with a maximum lift of 15-20 lbs;
• Ability to communicate information and ideas as well as listen and understand information and ideas presented through spoken words and sentences;
• Frequently interacts with others to obtain or relay information.
• Alpha Clinical Research of West Volusia, LLC is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

Job Type: Full-time

Pay: $41,600.00 - $52,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Work Location: One location

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