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Clinical Research Operations Lead

Alcanza Clinical Research
1 day ago
Full-time
On-site
Woodstock, Georgia, United States
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 manner
o. Filing SAE/Deviation reports to Sponsor and IRB as needed
p. Documenting and reporting adverse events
q. 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 minimum of 2 years of clinical or clinical research experience, or an equivalent combination of education and experience, is required. 6+ months of clinical research coordinator experience is required. Bi-lingual (English / Spanish) proficiency is a plus.

Required Skills:
  • Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
  • Must possess strong organizational, time management and problem-solving skills.
  • Well-developed written and verbal communication skills.
  • Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
  • Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
  • Must be professional, respectful of others, self-motivated, and have a strong work ethic.
  • Must possess a high degree of integrity and dependability.
  • Ability to work under minimal supervision, identify problems and implement solutions.
  • Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

Benefits


  • Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
  • Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.