Clinical Research Coordinator

Clinical Research Coordinator Department Operations

Employment Type: Full Time

Location: Coastal Carolina Research Center | Charleston SC

Reporting To: Nikki Shebelskie

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 SC TX VA 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) Role:

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:

• 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 answering 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 • 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, SIVs, and Investigator Meetings IMs as needed • May set up, train, and maintain all technology needed for studies

Minimum Qualifications:

• A Medical Assistant diploma, LPN, VN, EMT credential, or Associates 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. Benefits include:

• 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.