Key Responsibilities
- With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations.
- Study Design & Conduct (Fundamental Awareness): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
- Communication (Fundamental Awareness): Clearly, effectively and respectfully communicates to employees or customers.
- Clinical Research (Fundamental Awareness): Knows the primary resources available to accomplish the job.
- Can successfully research simple clinical questions pertaining to the functional area.
- Files and collates trial documentation and reports. Archives study documentation and correspondence.
- Demonstrates a systematic approach to problem solving.
- Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial.
- Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures.
- Procures equipment and supplies needed to fulfill project requirements.
- Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness.
- Attends to query resolution in a timely manner.
- Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice
- With direction assists with study completion, study closeout and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports
- Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants.
- Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. With guidance, assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation.
- Engages in open and positive communication with study participants and coworkers.
- With direction, performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and in a timely manner reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other safety reporting to appropriate funding/regulatory agencies is required.
- The responsibilities listed are a general overview of the position and additional duties may be assigned.
Schedule/Shift
Monday - Friday 8am-5pm (on-site)
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