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Company Description:
CHEAR Center (CC) is a clinical research facility that works with Major Global Pharmaceutical Company on clinical drug trials and which serves the community in the South Bronx. CC coordinates/manages all day-to-day drug trial operations and subject visits on-site at the CHEAR Center clinic. CC currently has multiple contracts with leading large, global pharmaceutical companies and anticipates continued growth.
Principal Investigator Role:
This individual will be responsible for overseeing the studies in addition to: conducting physical exams, reviewing labs/ECGs from study visits, reviewing medical records for study specific Inclusion/Exclusion entry criteria, contacting potential patients, calling patient MD offices as needed for eligibility for studies and with questions from medical records, etc.
In addition to overseeing the entire study, specific responsibilities include:
Conducting physical exams on study subjects as required by protocol
Sign off on labs and procedures as required
Providing Rx to subjects as needed for medication or imaging (x-rays etc)
Participate in Informed Consent discussions and ensure subjects have all questions answered prior to execution of study consent form
Ensuring that the informed consent process has occurred, is properly documented and filed as required
Being an available resource to support Clinical Research Coordinators (CRCs) as needed with clinical and process questions
Ensuring protocol is being followed
Review Medical Records to ensure and sign off on meeting eligibility
Adjudicating Adverse Events (AE) and Severe Adverse Events (SAE)
Identifying, recruiting and interviewing prospective subjects for clinical studies from CHEAR database/Medical Records and MD partnership EMRs
Familiarizing potential subjects with the details of the study through phone contacts and personal interviews
Liaise between potential patients and their PCPs as needed: treatment wash-outs, adding treatments, discussing studies
Meeting with representatives from sponsoring pharmaceutical firms and their designees or in-house staff for initial orientation to studies
Available as needed at initiation visits, monitor visits and site closeout visits
Answering questions and resolving issues in a timely manner as requested by Sponsor
Available for patient questions and study / patient safety issues
Be professional, respectful, and courteous with coworkers
Skills and experience:
Valid MD or DO license in the State of NY
Strong communication skills both written and verbal
Clinical Research Experience preferred but not essential
A deep desire to engage with patients and respond to their needs
