RESPONSIBILITIES:
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Responsible for answering Research department phone lines, taking messages and accurately relaying information to appropriate study coordinator.
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Reads and comprehends study protocols.
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Pre-screens patients to participate in clinical trials in accordance with trial protocols and schedules initial screening appointments.
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Responds to Research web inquiries.
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Assists the Research Department and/or Clinical Research Coordinators with delegated tasks.
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Assistance with the following may be delegated but is not limited to:
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Subject recruitment.
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Directly collects data from subject.
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Maintains source documents.
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CRF (case report form) completion and review for accuracy
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Ensures accurate labeling of slide photos.
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Filing and maintenance of all study related documents.
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Schedules study visits.
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Documents adverse events and notifies appropriate research personnel.
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Assist physicians, nurses or medical staff with medical procedures.
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Set up exam room for specific procedure as indicated.
- Provide patient education and literature.
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Take pre- and post-treatment pictures.
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Assists in cleaning rooms.
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Monitor physicians schedule to maintain timely flow.
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Check voicemail and triage calls according to protocol the same day.
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Participates and contributes to staff meetings.
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Assist research sites when needed to collect and record data as appropriate to the specific objectives of each study.
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Assist with weekly calls with different sites to follow up on sites research requests and update sites files as needed (licenses, and training, etc.)
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Collect patient data from database as needed.
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Assist with collection and in preparation of materials for submission to sponsors and regulatory (IRB, FDA, etc.,).
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Assist with tracking requests of equipment or supplies necessary for the study.
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Assist in maintaining and updating the research website as directed.
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Assist in coordinating site qualification and site initiation visits.
- Schedule the calibration and maintain records of research equipment calibrations, as specified by the requirements of the study.
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Maintain updated temperature records.
- As assigned by Research Director, assist coordinators in study data entry, answering queries and during monitoring visits or Audits.
- Assist coordinators in sample processing and shipping (IATA certificate).
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May conduct patient study visits as assigned by Research Director (GCP certificate).
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Assist in all duties of photography room as needed (upload photos, label photos, etc.,).
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Other Duties as assigned.
WORKING CONDITIONS:
Must be able to work with very minimal supervision in a normal medical and office environment with minimal exposure to dust, noise, etc., and be able to lift 25 - 50 pounds.
Education and Experience:
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Previous Clinical Research experience preferred
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Associate degree or equivalent experience
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Experience handling multiple telephone lines
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Proficient in Microsoft Office
- GCP, and IATA Certificate
Essential Skills and Abilities:
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Ability and willingness to function as part of a team.
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Ability to establish and maintain positive working relationships with physicians and providers.
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Ability to generate respect and trust from fellow employees and patients.
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Ability to show effective discretion and maintain confidentiality.
- Ability to work in a dynamic fast paced environment.
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Knowledge of spreadsheet applications.
- Possess excellent interpersonal skills to effectively communicate with patients for study recruitment.
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Ability to organize work, set priorities, complete tasks, produce high quality work, meet critical deadlines, and follow up on assignments with minimum direction.
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Excellent listening, oral and written communication skills.
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Must be proactive and resourceful.
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Demonstrates strong organizational and critical thinking skills.
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Tactful, mature and able to interact well with diverse personalities.
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Proficient in desktop applications such as MS Word, Excel, PowerPoint, Outlook, etc.
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Ability to operate basic office equipment such as a phone, fax, copier, printer etc.