Clinical Research Coordinator

Accel Research Sites; Katy (TX); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Health insurance

401k plan with match

Job summary

Alcanza in the United States is seeking a Clinical Research Coordinator to ensure the execution of studies in compliance with GCP, ICH, HIPAA, FDA regulations and SOPs at our Katy, TX site. The role involves screening patients, obtaining consents, performing visits, collecting data in EDC, and coordinating with the study team to maintain accurate documentation.

Candidates should have a Medical Assistant diploma or equivalent, with clinical research or clinical experience, and may be bilingual

Qualifications

• Clinical research or clinical experience (1 year minimum) with a Medical Assistant diploma or equivalent.
• Basic clinical procedures proficiency (BP, vitals, EKGs, phlebotomy).
• Bi-lingual English/Spanish is a plus.

Responsibilities

• Screen patients for study enrollment and obtain consents.
• Perform patient visits and collect data in EDC; document in source charts.
• Obtain vital signs and ECGs; maintain logs and study supplies.
• Coordinate with team on adverse events, SAE/Deviation reporting, and regulatory compliance.
• Set up and manage study visits, recruitment, and tracking as needed.

Skills

Clinical research experience

Bi-lingual English/Spanish

Strong organizational skills

Excellent communication skills

Education

Medical Assistant diploma

LPN/LVN credential

EMT credential

Associate’s degree

Tools

Electronic health records

Job description

Clinical Research Coordinator

Department: Operations

Employment Type: Full Time

Location: Olympus - Katy, TX

Reporting To: Mary Rogers

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, TN, 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 Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.

Key Responsibilities

Essential Job Duties: In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:

• Screening of patients for study enrollment;
• Patient consents;
• Patient follow-up visits;
• Documenting in source clinic charts;
• Entering data in EDC and answers queries;
• Obtaining vital signs and ECGs;
• 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;
• Requesting and tracking medical record requests;
• Updating and maintaining logs, chart filings;
• Maintaining & ordering study specific supplies;]
• Scheduling subjects for study visits and conducts appointment reminders;
• Building/updating source as needed;
• Conducting monitoring visits and resolves issues as needed in a timely manner;
• Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
• Filing SAE/Deviation reports to Sponsor and IRB as needed;
• Documenting and reporting adverse events;
• Reporting non‑compliance to appropriate staff in timely manner;
• Maintaining positive and effective communication with clients and team members;
• Always practicing ALCOAC principles with all documentation;
• May assist with study recruitment, patient enrollment, and tracking as needed;
• Maintaining confidentiality of patients, customers and company information, and;
• Performing all other duties as requested or assigned.
• 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;
• May set up, train and maintain all technology needed for studies.

Skills, Knowledge and Expertise

Minimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate’s degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred. 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);
• Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc
• Strong organizational skills and attention to detail.
• 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.