Job Opportunities

HCI is currently hiring an RN for its Clinical Events Services group.

The group is comprised of experienced nurses and physicians with medical backgrounds specific to a trial, who provide comprehensive medical review and adjudication of clinical endpoints. Clinical Events Committee adjudication is critical to ensuring the generation and recording of quality data in a clinical trial.
Clinical Reviewers are responsible for reviewing patient case report forms for assigned clinical trials; coding, narrating and adjudicating adverse events; and preparing patient narratives that are used to present cases to the Clinical Events Committee and for inclusion in safety and other reports to regulatory agencies. Part-time and full-time flexible schedules are available for the right candidates.
 

Primary Duties:

1.  Participates in study start-up activities:
Utilizes expert clinical knowledge and clinical trial experience to provide feedback to project teams, sponsors, and other HCRI personnel on proposed protocols and case report forms for new trials. Provides clinical support to IT and other HCRI personnel involved in the construction of the adverse event database.
2.  Performs adverse event management for assigned trials:
Identifies potential and actual problems with the standard database queries and seeks appropriate programming and/or physician support for resolution. Demonstrates the ability to follow-up with appropriate HCRI personnel until the issues are resolved and the queries are operational. Runs designated database queries to identify patient charts that require review for adverse events. Succinctly compiles information regarding the patient’s hospital course and follow-up in a standardized narrative form for inclusion in CEC documents, DSMB, PMA, and other reports. Determines need for additional information for accurate coding and reporting of adverse events, and reviews with Project Teams.
3.   Provides clean, adjudicated adverse event databases to Biometrics prior to analysis of assigned trials: Completes data cleaning and clarification in the adverse events database. Collaborates/interacts with Biometrics to identify specific content related to adverse events for reports (DSMB, FDA, other request analyses). Edits narratives for inclusion in FDA and other reports.

Secondary Duties:
1. Utilizes clinical expertise to respond to FDA requests for data clarification and/or additional data related to both adverse events and clinical issues.
2. Acts as an expert clinical consultant to the Project Teams for adverse events, device failures, and other clinical issues.
3. Participates in CEC Meetings on a rotational basis to provide technical / clinical support.

Requirements:
Education:  RN
Yrs. of related experience: 2+ years in Cardiology/Oncology, Neurology, or Vascular Medicine.
No previous research experience is required as an intensive 8 week training course, including basic computer skills, will be provided. This is a great opportunity to learn the skills required for a career in Clinical Research.

HCRI also offers a full range benefits including subsidized parking or discounted T passes; health, dental and vision insurances; 3 weeks paid vacation; flex time; personal / sick time; 401K matching; disability insurance; tuition reimbursement; career development opportunities and more!
Please send resumes to: hcrijobs@hcri.harvard.edu or fax 617.632.1343.

HCRI is an equal opportunity employer that values the strength diversity brings the workplace. For more information please visit our website: www.hcri.harvard.edu