Clinical Research Coordinator Sr - Fetal Care Center

Location:

Aurora

Position Type:
Regular

Regular/Temporary:
Regular

The Clinical Research Coordinator Senior is a seasoned Coordinator who can work across multiple complex modalities and is responsible for participating in the day-to-day operations of complex, multi-site clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. Performs a variety of administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data.

Facilitates the accomplishment of research programs and/or study goals. Works independently and leads others in navigating the clinical research environment and participates in a variety of departmental and/or divisional initiatives. Provides oversight to Clinical Research Coordinators and other related team members. Works under minimal supervision.

This position will be supporting the Colorado Fetal Care Center. At the Colorado Fetal Care Center, we care for moms and babies, before birth and beyond. That means we're able to provide comprehensive, world-class testing, diagnosis, treatment and care for unborn babies and moms-to-be. Our family-centered fetal care center makes difficult diagnoses and complicated pregnancies easier on mom, baby and the whole family.

As one of the few centers in the country offering a complete array of treatment for the complex needs of infants and expectant mothers, we care for the highest-risk babies.

Physicians all over the country refer their patients with the most complex fetal diagnoses to our Center. This means our team manages and treats higher volumes of these rare conditions - and higher volumes result in better experience.

Day shift, 08:00 a.m.

- 16:30 p.m.

May require occasional weekend coverage

Hybrid eligible

• Prepares and takes part in site initiation, monitoring, closeout visits, and document storage activities, and related training, creation of SOPs and implementation of operational plans. Assembles the necessary parties to ensure that all required agreements are in place. Utilizes and assists with training team members on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations.
  
  Scores tests, enters data, and completes required forms accurately and according to protocol. Leads the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies, identifies issues recommends solutions.
• Identifies and liaises with various regulatory partners (IRB, compliance, legal) as needed for clarity in effectively supporting research operations. Identifies gaps and participates in policy, standard operating procedures and guideline development as required to enhance research operations in the CHRE. Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.
• Screens, schedules, consents participants in a variety of clinical research programs and/or studies. Explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Conducts difficult, sensitive conversations with patients/families. Employs, evaluates, and assists with the implementation of innovative solutions to maximize recruitment and retention, and assists participants with individual needs. Collects information to determine feasibility, recruitment, and retention strategies.
  
  Collects, prepares, processes, ships, and maintains inventory of research specimens.
• Develops and optimizes protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols. Completes and submits along with regulatory team the AE reports, according to institution and sponsor-specific reporting…