Senior Human Sub Research Spec

Responsibilities

• Conducts unstructured interviews with subjects and families as required by protocol;
• Performs clinical research related procedures (blood draws and sponsor specific delegated responsibilities);
• Makes measurements, records, and reports indicators of patient health status;
• Evaluates subjects for local or systemic reactions to determine adverse events to study medication;
• Discusses with subjects’ potential adverse events and SAEs and participating in grade of events;
• Participates in the reporting of subject serious adverse events (SAE) and filing of these in a timely manner to sponsors and IRBs;
• Identifies subject pool, eligibility screening in clinic settings and/or telephone screens;
• Medical history review;
• Obtains informed consent and proceeds with enrollment procedures;
• Answers patient questions to ensure they understand the clinical study and their involvement;
• Performs all protocol required study procedures on subjects which include but are not limited to venipuncture, urine collection, Bladder Scans, Uroflowmetry, pad weight tests and ECGs;
• Reviews and interprets study guidelines for next steps necessary for the processing and/or shipment of samples;
• Tracks and prepares requests for payments to subjects;
• Ensures assigned studies are conducted accurately, conducts subject visits per protocol which may include standard-of-care visits, performs clinical research procedures (i.e., blood draw, urine sample collection), prepares, stores, and ships biological specimens, requests tissue from Pathology, verifies laboratory data, distributes study medication per protocol, documents adverse events accurately, consults with study investigators, regularly interacts with clinic, off-site, and laboratory staff as it pertains to subject visit requirements, follows subject visits.

Qualifications

• Bachelor's degree and 5 years of experience in human subject coordination required;
• Phlebotomy skills for adult and pediatric patients;
• Good computer skills;
• Independent and organized professional with superior interpersonal skills, sound judgment and good oral and written communication skills;
• Strong attention to detail and must be able to problem-solve effectively;
• Knowledge of computer databases including eRecord and ePARC, Word and Excel software programs;
• SOCRA - Certification In Clinical Research preferred;
• Association of Clinical Research Professionals (ACRP) preferred.