Job Description

EMPLOYER INFORMATION:

Organization Name: MedPharmics Location: Multi

MedPharmics is a clinical research consortium with sites located in Arizona, Alabama, Louisiana, New Mexico and Mississippi. Our sites enlist “Medical Heroes” for clinical research trials to determine the efficacy and safety of new medications or devices, while ensuring the safety and protection of our participants. Therefore, MedPharmics requires new employees to be immunized against COVID-19. All employees must have received required doses of an approved COVID-19 immunization before starting work. The Company will consider accommodations for disability and religious based reasons.

https://medpharmics.com/

PURPOSE:

MedPharmics is seeking a highly motivated CLINICAL TRIAL QUALITY ASSURANCE SPECIALIST to join their team! This position provides leadership and oversight over the daily clinical  research activities according to the organizations SOPs, GCP and FDA/ICH guidelines. Incumbent will be responsible for internal, client, regulatory and/or vendor audits, as well as initiation and close-out study activities. Duties will encompass all QA oversight at multiple site locations and oversight of regulatory documents.

ESSENTIAL DUTIES & RESPONSIBILITIES:

·       Ensure that the conduct of the trial complies with protocols, current ICH/GCP, FDA CFR, along with other applicable Sponsor and regulatory requirements, and requirements of state/federal regulations;

·       Conduct site pre-qualification and initiation visits; verifying that assigned research staff, facilities and investigational products have adequate qualifications and resources;

·       Creates Pre-Screening Scripts for recruiters and oversees regulatory submission process for Sponsor and IRB approval;

·       Conduct on-site clinical monitoring that includes: protocol training, document review, accurate data recording in source documents and document uploading into eSource/eRegulatory System, verify patient data, ensuring adherence to the clinical protocol, site SOPs, investigational product accountability, verification of product shipping/storage conditions, etc.;

·       Actively leads or assists with activities in the areas of Internal Quality Audits and Corrective and Preventive Actions (CAPA);

·       Monitor adverse events, concomitant medications, and inter-current illnesses and verify they are reported in accordance with the protocol ;

·       Conduct closeout site visits, including reviewing record retention requirements, investigational product reconciliation and securing and reviewing investigator’s final report;

·       Stays current with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best practice standards;

·       Participate in reviewing protocols, amendments, investigator brochures, Informed Consent Forms (ICFs) and CRFs and facilitate Institutional Review Board (IRB) submission, queries, and approval;

·       Verify and ensure that the rights and well-being of the human subjects enrolled in the clinical trials are protected and that the reported trial data are accurate, complete, and verifiable from source documents;

·       Oversees regulatory documentation, assuring compliance with IRB policies and procedures, FDA regulations, and sponsor requirements;

EDUCATION:

• Associate's Degree required, Bachelor’s highly preferred (Life or Physical Sciences degree)
• Human subject’s protection training or ICH/GCP training highly desirable

QUALIFICATIONS:

• Minimum 4 years experience in Clinical Research

• Experience working with FDA regulations, and ICH/GCP guidelines for the conduct of clinical research required

• Attention to detail and strong verbal and written skills required

• Ability to travel up to 20% for clinic activities, attend investigator meetings or vendor visits/audits 

• Lift, push, and/or pull objects up to 50lbs; stand or walk with objects up to 25lbs; and possible exposure to radiation, cuts/punctures, bloodborne/airborne pathogens, and/or challenging individuals

• Proficient with Microsoft Office software

WE OFFER A COMPETITIVE SALARY AND A COMPREHENSIVE BENEFIT PACKAGE INCLUDING HEALTH/DENTAL/VISION, PAID HOLIDAY AND VACATIONS, AND 401K. WE ARE AN E.O.E.

Company Description

MedPharmics follows a philosophy that "If we work hard and treat each other well, we will find success." MedPharmics conducts clinical trials in 8 sites across 5 states; Alabama, Arizona, Louisiana, Mississippi, and New Mexico. The teams work together at the sites to conduct high-enrolling clinical trials for studies in phases 1-4. The high-energy environment offers every staff member the opportunity to learn and elevate their career to the next level. Staff has continual learning opportunities to grow their careers.In April 2022, MedPharmics hosted the first full company training meeting for 3 days in Las Vegas.