Alcanza Clinical Research
Clinical Research Coordinator
Department:
Operations
Employment Type:
Full Time
Location:
Boston Clinical Trials | Roslindale, MA
Reporting To:
Joanne Monaghan
Description Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, 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:
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.
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Operations
Employment Type:
Full Time
Location:
Boston Clinical Trials | Roslindale, MA
Reporting To:
Joanne Monaghan
Description Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, 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:
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.
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