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The Clinical Research Coordinator (CRC) is responsible for the management of all clinical trials. on behalf of the Principal Investigator (PI) under the guidance of Urgent Care Clinical Trials (UCCT). The CRC must ensure that clinical trials (or studies) are run according to specific requirements, regulatory procedures, and protocols. In addition to providing and coordinating clinical care, a CRC has a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation, accuracy of data collection, resolution of queries, patient scheduling, management of study drug, data recording and follow up. Care received by research participants is driven by study requirements and the collection of research data as well as clinical indications. The CRC will work with the ultimate goal of protecting patients participating in research studies as well as to promote good clinical practices and professional management of clinical studies.

Primary Job Responsibilities:

  • Oversee daily functions of multiple clinical trials
  • Work with the Principal Investigator, UCCT staff, site staff, patients, Sponsors, CROs and IRBs.
  • Adhere to the guidelines of FDA GCP/ICH as well as study protocol and company SOPs.
  • Complete feasibility questionnaires based on site information as well as complete regulatory start up packages
  • Responsible for patient recruitment including submitting any advertising for sponsor and IRB approval as well as maintaining records of recruitment efforts and screening.
  • Obtain informed consent under the guidance of the PI.
  • Coordinate patient visits from screening to follow up.
  • Create source document templates, as needed, for clinical trials.
  • Ensure subjects meet all inclusion/exclusion criteria and have been properly consented prior to screening and enrollment into any clinical trial.
  • Coordinate, record and manage subject study data by maintaining accurate and complete source.
  • Complete case report forms and queries in a timely manner.
  • Manage all training for site staff including UCCT required training and protocol specific training.
  • Perform physical assessments such as collecting height, weight, vitals, ECGs, etc…
  • Perform basic lab procedures such as collecting, preparing, and shipping specimens.
  • Oversee and maintain records of the proper receipt, storage, distribution and any shipments or transfer of investigational product.
  • Attend and facilitate sponsor visits including PSSVs, SIVs, IMVs, COVs and audits.
  • Communicate with IRBs, Sponsors, CROs, and outside vendors.
  • Participate in regular team calls to review the status of current projects, identify site specific needs, and offer remote support when time permits.

Qualifications and Skills:

  • Associates/Bachelor Degree or/with equivalent experience in a related field or position
  • Prefer 2 years of research experience in a clinical research setting, Phase I-IV
  • Current GCP and IATA certification preferred
  • Understanding of HIPAA, federal, state and local laws relating to privacy and consent
  • Knowledge of clinical trials terminology and forms such as 1572, ICFs and SAE reporting preferred
  • Excellent written, computer and verbal communication skills
  • Ability to organize and prioritize tasks
  • Works well in a team but is self-driven

The Clinical Research Coordinator (CRC) is responsible for the management of all clinical trials. on behalf of the Principal Investigator (PI) under the guidance of Urgent Care Clinical Trials (UCCT). The CRC must ensure that clinical trials (or studies) are run according to specific requirements, regulatory procedures, and protocols. In addition to providing and coordinating clinical care, a CRC has a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation, accuracy of data collection, resolution of queries, patient scheduling, management of study drug, data recording and follow up. Care received by research participants is driven by study requirements and the collection of research data as well as clinical indications. The CRC will work with the ultimate goal of protecting patients participating in research studies as well as to promote good clinical practices and professional management of clinical studies.

Primary Job Responsibilities:

  • Oversee daily functions of multiple clinical trials
  • Work with the Principal Investigator, UCCT staff, site staff, patients, Sponsors, CROs and IRBs.
  • Adhere to the guidelines of FDA GCP/ICH as well as study protocol and company SOPs.
  • Complete feasibility questionnaires based on site information as well as complete regulatory start up packages
  • Responsible for patient recruitment including submitting any advertising for sponsor and IRB approval as well as maintaining records of recruitment efforts and screening.
  • Obtain informed consent under the guidance of the PI.
  • Coordinate patient visits from screening to follow up.
  • Create source document templates, as needed, for clinical trials.
  • Ensure subjects meet all inclusion/exclusion criteria and have been properly consented prior to screening and enrollment into any clinical trial.
  • Coordinate, record and manage subject study data by maintaining accurate and complete source.
  • Complete case report forms and queries in a timely manner.
  • Manage all training for site staff including UCCT required training and protocol specific training.
  • Perform physical assessments such as collecting height, weight, vitals, ECGs, etc…
  • Perform basic lab procedures such as collecting, preparing, and shipping specimens.
  • Oversee and maintain records of the proper receipt, storage, distribution and any shipments or transfer of investigational product.
  • Attend and facilitate sponsor visits including PSSVs, SIVs, IMVs, COVs and audits.
  • Communicate with IRBs, Sponsors, CROs, and outside vendors.
  • Participate in regular team calls to review the status of current projects, identify site specific needs, and offer remote support when time permits.

Qualifications and Skills:

  • Associates/Bachelor Degree or/with equivalent experience in a related field or position
  • Prefer 2 years of research experience in a clinical research setting, Phase I-IV
  • Current GCP and IATA certification preferred
  • Understanding of HIPAA, federal, state and local laws relating to privacy and consent
  • Knowledge of clinical trials terminology and forms such as 1572, ICFs and SAE reporting preferred
  • Excellent written, computer and verbal communication skills
  • Ability to organize and prioritize tasks
  • Works well in a team but is self-driven

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