Essential Duties & Responsibilities
Includes the following. Other duties may be assigned.
- Follows directions provided by the Medical Director/Director of Research-Southern Bureau and Manager of Research Operations and acts accordingly.
- Safeguards the rights, safety and well being of all trial subjects at all times.
- Employs discretion and judgment in organizing priorities, completes tasks in a timely manner and handles all patient information confidentially.
- Assists with answering incoming telephone calls, determines purpose of the callers, and forwards calls to appropriate personnel.
- Assists Research Director and Manager with the identification of potential study participants per the inclusion and exclusion criteria of various studies.
- Receives laboratory results over the telephone and transmits them to the licensed nurse and/or assigned Research Director/Manager and/or the patient’s medical provider in a timely manner.
- Utilizing AHF computer information system provides data entry for laboratory results. Ensures that all data entry is performed daily and accurately.
- Obtains necessary reviews and signatures on labs, EKG’s, radiology reports, or reports from investigators prior to distributing to the appropriate Medical Director/Manager of Research Operations.
- Collaborates with the Medical Director/Manager of Research Operations to complete and maintain case report forms in compliance with good clinical practices.
- Assists Manager of Research Operations with pill counts and drug accountability.
- Assists with filing regulatory documents, case report forms (CRF's) and source documents.
- Obtains detailed knowledge of all components of assigned study protocols through independent analysis and review of study, prior to study initiation. Addresses with supervisor prior to study initiation, any components of the study that require additional information or clarification.
- Performs daily computer searches to identify potential study participants.
Interviews potential study participants and assists in recruitment including answering questions regarding the consent form to substantiate their participation in the study.
- Ensures that participants have signed all required consent forms before becoming involved in any aspect of the study and provides the participant a copy of the consent form.
- Assists Medical Director/Manager of Research Operations with vital signs, laboratory specimen collection and preparation. Ensures that laboratory specimens collected are processed and shipped according to study requirements.
- May assist with scheduling all visits and procedures and provides instructions and dates to participants.
- May liaison with study monitors to address questions or requests during and between audit visits.
- Provides study sponsor information during and between audit visits.
- Works with study monitors during monitoring visits to provide data clarification/corrections when needed.
- Works with office staff to arrange for interpreters as needed for non-English speaking participants.
- Timely completes and documents necessary participant assessments at each study visit.
- On assigned studies, acts as a liaison between study participants and their physicians concerning any problems, adverse reactions, etc., related to the study medication.
- Notifies participants, physicians, monitors and institutional review boards (if required) of any serous or untoward adverse reactions due to the individual’s participation in a clinical trial.
- Immediately reports to the principal investigator and institutional review board any known deviations from established policies or procedures.
- Works with Regulatory Affairs Specialist to complete IRB semi-annual and annual study status reports.
- Obtains clarification from Research leadership and /or principal investigator of established policy prior to taking action, which might deviate from standards.
- Maintains a high level of expertise and professionalism at all times.
- Constantly continues to upgrade his/her education thru reading of clinical literature, attending continuing education classes, conferences and/or seminars.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
High school diploma or general education degree (GED); or one to two years related experience and/or training; or equivalent combination of education and experience.
We at AIDS Healthcare Foundation believe that each individual is entitled to equal employment opportunities without regard to race, color, creed, gender, sexual orientation, gender identity, marital status, national origin, age, veteran status or disability. The right of equal employment opportunity extends to recruiting, hiring selection, transfer, promotion, training and all other conditions of employment.