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Medical Reviewer/Safety Reviewer
North Chicago, IL
Job Description
Job Title : Medical Reviewer
Length of Contract: 12 Months
Location/Site: Remote
* Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review of labs, vital signs, cardiac, medications, medical history, and can communicate with Study Lead any findings.
* Provide review of safety-related data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills.
* Monitoring of safety-related queries to Investigators.
* Adheres to regulatory guidance, protocols, departmental processes and policies under minimum supervision.
* Current with knowledge of ICH, FDA, and EMA regulatory guidance's affecting safety surveillance.
Qualifications:
* Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred.
* A minimum of 2 years of clinical practice experience is required and 1-year drug safety experience preferred.
* Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and data assessment.
* Ability to present accurate and medically sound safety data, both orally and in writing.
* Effective communication skills in delivering study-related information.
* Proficiency in Computers (Windows, Word, Excel).
Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. 3-5 Years Experience Level.
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
Length of Contract: 12 Months
Location/Site: Remote
* Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review of labs, vital signs, cardiac, medications, medical history, and can communicate with Study Lead any findings.
* Provide review of safety-related data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills.
* Monitoring of safety-related queries to Investigators.
* Adheres to regulatory guidance, protocols, departmental processes and policies under minimum supervision.
* Current with knowledge of ICH, FDA, and EMA regulatory guidance's affecting safety surveillance.
Qualifications:
* Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred.
* A minimum of 2 years of clinical practice experience is required and 1-year drug safety experience preferred.
* Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and data assessment.
* Ability to present accurate and medically sound safety data, both orally and in writing.
* Effective communication skills in delivering study-related information.
* Proficiency in Computers (Windows, Word, Excel).
Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. 3-5 Years Experience Level.
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
2+ years
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