Clinical Research Operations Lead

Department: Operations

Employment Type: Full Time

Location: North Georgia Clinical Research

Description

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.

The Clinical Operations Lead is responsible for the execution of assigned studies as well as on-site oversight and support, to help ensure execution and coordination of all site clinical research activities visits, documentation, and follow-up actions according to ICH/FDA guidelines, GCP, sponsor protocols, company SOPs, and policies. 

Key Responsibilities

Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP/GDP/ALCOAC, ICH regulations and guidelines:

a.       Screening of patients for study enrollment

b.       Patient consents

c.       Patient follow-up visits

d.       Documenting in source clinic charts

e.       Entering data in EDC and answers queries

f.        Obtaining vital signs and ECGs

g.       May perform basic lab procedures per protocol, such as:  blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up

h.       Requesting and tracking medical record requests

i.         Updating and maintaining logs, chart filings

j.         Maintaining & ordering study specific supplies

k.       Scheduling subjects for study visits and conducts appointment reminders

l.         Building/updating source as needed

m.     Conducting monitoring visits and resolves issues as needed in a timely manner

n.       Ensuring study related reports and patient results are reviewed by investigator 
           in a timely mannero.       Filing SAE/Deviation reports to Sponsor and IRB as neededp.       Documenting and reporting adverse eventsq.       Reporting non-compliance to appropriate staff in timely manner

• Complete all needed activities for study start-up, including completing 
• required training, uploading / printing certificates to file in ISF, etc.;
• Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed;
• Responsible for maintenance and calibration of equipment & scales at site;
• Overall site management support with a focus on enhancing efficiencies, facility management, patient safety and             protocol/GCP/SOPs/policy/regulatory compliance;
• Collaborating with manager to support site performance goals, proactively  identify and resolve issues, meet expected study milestones (such as site activation targets, enrollment targets, etc.), and ensuring overall quality of the data;
• Reviewing the performance dashboards and other clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency); 
• Assisting with oversight of site staff assigned to the study and routinely assessing study-specific process and training compliance, CMP compliance, and identifies emerging risks. May assist with development and support execution of corrective action plans at site and study level;
• Assisting with people management activities including timecards, absence tracking/approvals, new hire training, interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching and termination meetings;
• Assisting with initial and ongoing trainings for new and existing staff, regarding protocol specificities, Case Report Form (CRF) completion, source & regulatory, Standard Operating Procedures (SOPs), GCP, IATA, clinical plans and guidelines, and timelines for the study;
• Collaborating with investigators to ensure patient safety and meeting client goals and timelines;
• Employing problem-solving skills to propose and implement risk mitigations;
• Participating and, at times, presenting in management, production, and site meetings;
• Perform all other duties as required or assigned.

Skills, Knowledge and Expertise

Minimum Qualifications:  An associate’s degree OR a CMA, LPN, LVN, or EMT credential AND a mini