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Posted: Sunday, February 11, 2018 8:17 PM

Req ID:15867
Shift: Any
Employment Status:AF : Active : Regular : Full Time
Job Summary 13;
Performs any combination of the following for the purpose of conducting and monitoring clinical trials:
* Develop, coordinate and implement research and administrative strategies essential to the successful management of clinical trials
* Prioritize and perform multiple tasks and ensure the execution and timely completion of assigned protocols.
* Perform a variety of duties involved in the organization, oversight, documentation and compilation of clinical information and data. 13;
Job Responsibilities 13;
1. Protocol Preparation/IRB Submission
*Assist in preparing protocol narrative for IRB submission.
*Prepare/revise protocol consent documents according to regulatory standards.
*Maintain accurate database, and files of all IRB communications.
*Preparation of annual or interim progress reports.
*Ensure timely reporting of severe adverse events according to regulations.
*Timely submission of protocol amendments and advisories according to regulations.
*Continual update and revision of databases.
*Conduct routine self:audit, ensuring appropriate study conduct. Communicate with staff if deficiencies are noted.
*Participates and helps organize Quality Assurance
*Prepares site and medical records for regulatory audits.

2. Protocol Communication
*Protocol review to determine eligibility, pre:treatment requirements.
*Announce protocol opening, suspension, and closure. Ensure updated copies of protocol are distributed and maintained in key areas at CHOP and at the Hospital of the Univ., of Penn when appropriate.
*Serves as a liaison to CHOP investigators, nurses, pharmacists, surgeons, pathologists, and radiologists for information exchange regarding clinical trials.
*Patient and family education concerning NBDT studies
*Maintains for physicians, parent/patient, correct treatment plan (therapy roadmap). When necessary, develops tools such as calendars, fast fact sheets that assist in the delivery of treatment and aide in accurate protocol interpretation and compliance.

Job Responsibilities (Continued) 13;
3. Study enrollment
*Ensures written consent obtained prior to treatment and enrollment.
*Clinically evaluates all patients and ensures only eligible subjects are enrolled.
*Source documents all eligibility and pre:treatment requirements prior to enrollment, as well as on going source documentation as appropriate to the research.
*Investigate study status of patients referred for NBDT studies from outside facilities.

4. Case management for timely Record Analysis; Abstraction; Data Submission.
*Analyze medical record and abstract pertinent data for completion of case report forms.
*Communicates with family and team to ensure accurate reporting of toxicity, complications and adverse events per protocol guidelines.
*Ensures timely data submission.
*Monitors compliance to trial. Communicates with physicians regarding deviations from protocol standards and/or treatment.
*Reviews medical record to ensure documentation is adequate for study validation and chart audits. Advise physician/nursing staff of appropriate documentation.
*Ensure required specimens are collected and shipped according to protocol guidelines.
*Provides study coverage for industry studies and PK trials necessitating blood draws or other bodily specimen.
*Works seamlessly with the Nurse Practitioners to schedule and is available for outpatient visits related to the protocols and routine follow:up.

5. Continuing Education.
*Must maintain current clinical research certification. If not certified, will seek clinical research testing and certification within 2 years of hire.
*Attends at least one annual Cooperative Group Clinical Research Workshop. 13;
Job Responsibilities (Continued) 13;
Required Licenses, Certifications, Registrations 13;
None 13;


• Location: South Jersey

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