C

Care Access

Global health education, access, and research

Clinical Research Coordinator 2

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeSt. Louis, MO, USA

About the Job

Requirements

  • Ability to understand and follow institutional standard operating procedures.
  • Working knowledge of medical and research terminology, federal regulations, and good clinical practices.
  • Ability to operate independently for most study activities and escalate complex issues as needed.
  • Ability to communicate and work effectively with a diverse team of professionals.
  • Strong organizational, prioritization, and leadership capabilities, with attention to detail.
  • Computer skills, including use of clinical trials databases, interactive voice response systems, electronic data capture, Microsoft Word, and Microsoft Excel.
  • Ability to think critically and solve problems.
  • Professional writing and communication skills.
  • Ability to manage stakeholder communications and facilitate visits and meetings.
  • Ability to work independently in a fast-paced environment with minimal supervision.
  • Bachelor's degree preferred, or equivalent combination of education, training, and experience.
  • Three years of prior Clinical Research Coordinator experience required.
  • Recent phlebotomy experience required.

Responsibilities

  • Prioritize activities with specific regard to protocol timelines.
  • Maintain adherence to Food and Drug Administration regulations and International Council for Harmonisation guidelines while conducting clinical trials.
  • Maintain effective relationships with study participants and Care Access Research personnel.
  • Balance protocol needs with patient experience and proactively address concerns.
  • Monitor quality metrics, prevent deviations, and resolve queries quickly.
  • Interact professionally with patients, representatives, investigators, and Care Access Research personnel and management.
  • Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and sponsor or contract research organization representatives.
  • Mentor Clinical Research Coordinator I peers and provide onboarding and day-to-day guidance.
  • Identify adverse events and serious adverse events, and promptly notify the Principal Investigator and sponsor where appropriate.
  • Conduct moderately complex studies involving mixed visit types, active investigational products, and adverse event and serious adverse event workflows.
  • Operate as the sole Clinical Research Coordinator onsite when needed.
  • Prescreen study candidates.
  • Obtain informed consent according to Care Access Research standard operating procedures.
  • Complete visit procedures in accordance with the protocol.
  • Complete basic clinical procedures, including blood draws, vital signs, and electrocardiograms.
  • Review laboratory results, electrocardiograms, and other test results such as magnetic resonance imaging for completeness and alert values, and ensure timely investigator review.
  • Discuss study medication, required procedures, eligibility criteria, and impact on office flow with the Investigator and site staff.
  • Record data legibly and enter it in real time on paper or electronic source documents.
  • Accurately record study medication inventory, medication dispensation, and patient compliance.
  • Resolve data management queries and correct source data within sponsor-provided timelines.
  • Assist regulatory personnel with completing and filing regulatory documents.
  • Assist in creating and reviewing source documents.
  • Assist with planning and creating appropriate recruitment materials.
  • Assist in developing recruitment plans and obtaining lists of potential candidates to contact from the subject database.
  • Work with the recruitment team to call and recruit subjects.
  • Review and assess protocols, including amendments, for clarity and logistical feasibility.
  • Ensure all training and study requirements are met before trial conduct.
  • Attend Investigator meetings as required.
  • Own studies, prioritize competing demands, and mentor Clinical Research Coordinator I colleagues.
  • Ensure adequate supplies have arrived onsite for protocol initiation, including laboratory kits, study medication, specialized equipment, and interactive voice response and electronic data capture access and passwords.

Desired Qualifications

  • One year of experience as a Care Access Research Clinical Research Coordinator is preferred.

About the Company

Care Access

Global health education, access, and research

Care Access coordinates global efforts to improve health by educating people about health, helping them access needed resources, and enabling participation in medical research to develop new medicines and cures. Its approach involves a global network and services that educate individuals, connect them with health resources, and recruit participants for clinical studies, thereby supporting the development of new treatments. Unlike companies that focus on a single market or product, Care Access operates worldwide and focuses on easing access to information, services, and research opportunities for diverse populations. The goal is to make health information and access more available and participation in health studies easier, with the aim of making the future of health better for everyone.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Boston, MA
Founded
2016

Recently Posted Jobs

Explore more opportunities at Care Access

See more jobs