Clinical Research Coordinator II

1 month ago

Roslindale, United States Alcanza Clinical Research Full time
Clinical Research Coordinator II

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.

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

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, ICH regulations and guidelines:
  • 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: phlebotomy, 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;
o Filing SAE/Deviation reports to Sponsor and IRB as needed;

o Documenting and reporting adverse events;

o Reporting non-compliance to appropriate staff in timely manner;

o Maintaining positive and effective communication with clients and team
members;

o Always practicing ALCOAC principles with all documentation;
  • 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;
  • Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed;
  • Assist with training of new research assistants and coordinators;
  • Assist with scheduling and planning for visit capacity for assigned studies;
  • May set up, train and maintain all technology needed for studies;
  • May assist with study recruitment, patient enrollment, and tracking as needed;
  • May handle more complex study assignments and volumes;
  • May participate in community outreach / education events;
  • Maintaining confidentiality of patients, customers and company information, and;
  • Performing all other duties as requested or assigned.
Skills, Knowledge and Expertise

Minimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential AND 2+ years of clinical research coordination 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. CCRC or CCRP credential and BLS certification 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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