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Clinical Research Coordinator

Indago Research & Health Center Coral Gables, FL

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC will complete all study related procedures and distribute study medications and instructions to research subjects under the direction of the Investigators, Clinic staff, CROs and Sponsors. They will maintain accurate confidential files and documentation of the study participants. The CRC will also engage in the explanation of what is expected of the research subjects and understand their concerns, requiring excellent interpersonal and communication skills. All duties are carried out in accordance with the company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable local, State and Federal regulations.

Primary Responsibilities

· Reviews study protocols and complete study trainings to become familiar with the study and Sponsor’s requirements.

· Ensures site receive access, approvals, and study supplies i.e., lab kits, study medication, diaries, questionnaires, rater training approval (if applicable), IRB approvals including but not limited to ICF English/Spanish protocol approval, and recruitment materials prior to study initiation.

· Attends IM, SIV and any other training session required by the sponsor.

· Develops their own source documents following site’s template and gives them to their direct supervisor for approval.

· Meets with the Regulatory Department to ensure that the study is captured correctly in the system including the window period frequency of study visits and verifies the patient stipend reflects the same amount as the ICF.

· Perform a meeting with the laboratory personnel and assistant coordinator(s) (if applicable) prior to initiation of the study to train them on the protocol.

· Makes sure that all personnel listed on the Delegation Log have completed all the trainings required by sponsors.

· Review each tab of the Regulatory Binder including but not limited to 1572, Delegation Log, Temperature Log, FDF, CVs, Medical Licenses, etc. to make sure all documents are filed and updated as needed.

· Conduct, organize, and ensure compliance of clinical research trial according to protocol stipulated regulations, INDAGO RESEARCH & HEALTH CENTER SOPs, GCP guidelines.

· Consents study subjects and document the process on source documents.

· If data entry personnel are not available, the CRC must enter subject data in EDC within 24 hours of the visit being performed.

· Keeps site system up to date regarding subject status in trial.

· Ensures all deviations, violations, AEs, SAEs are captured, recorded, followed, and reported to sponsor/IRB in a timely manner.

· Performs study related procedures in compliance with protocols including but not limited to drug dispensation, compliance and drug accountability, vital signs, phlebotomy, ECG, questionnaires, and surveys.

· Records visits in IVRS/IWRS on the same day of the visit.

· Meets INDAGO RESEARCH & HEALTH CENTER’s expected enrollment, retention, screens failure goals.

· Ensures that the laboratory is following protocol requirements and that all samples are successfully packed and sent to the central/local laboratory as indicated.

· Ensures proper follow up of subjects that have missed their appointments until they come back for their visit or are declared LTFU or withdrawal.

· Reviews with the receptionist, lab personnel and the assistant CRC the subjects that are scheduled for the following day.

· Stays up to date by doing individual research on new guidelines of the Regulatory Agencies.

· Resolves any CRA queries before the monitored visit is over.

· Resolves any pending action items within 7 days of the monitored visit.

· Assists monitors during the monitoring visit or remote monitoring visit.

· Maintains PI/Sub-Is/Lead CRC always informed on all aspects of the trial by giving them copies of but not limited to all follow-up letters, sponsor/IRB relevant correspondence, brings lab alerts AE, SAE to their attention.

· Works extra hours, weekends or holidays when required.

· Completes additional tasks as required by a specific protocol.

Education and Experience:

· College degree required

· FMG, MA Certificate or RN License

· 2 years of Clinical Research experience required

Knowledge, Skills and Abilities:

  • Clinical Terminology proficiency
  • Excellent communications skills (interpersonal, written, verbal)
  • Bi-lingual English/Spanish required
  • Knowledge of Office 365 Solutions
  • CCRC preferred

Job Type: Full-time

Benefits:

  • 401(k) & 401(k) matching
  • Health insurance
  • Paid time off

Schedule:

  • Monday to Friday – 8:00am – 4:30pm
  • Work Location: Hialeah, FL
  • One location

· Company's website: www.indagoresearch.com

· Work Remotely: No

Indago Research & Health Center, Inc., is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Company Description
Research Center facility that conducts an array of studies for various pharmaceutical sponsors ranging from Phase I – IV for adult and pediatric participants alike.

Indago Research & Health Center

Why Work Here?
Great Clinical Research Company with a professional and family oriented atmosphere.

Research Center facility that conducts an array of studies for various pharmaceutical sponsors ranging from Phase I – IV for adult and pediatric participants alike.

Indago Research & Health Center's Logo

Address

3700 W 12TH AVE HIALEAH FL 33012 STE 300

Coral Gables, FL
USA

Industry

Healthcare

Website

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