Clinical Research Coordinator

Nemours-Children; Orlando (FL); On-site; USD 45,000 - 70,000; Full time

Job summary

Nemours is seeking a Clinical Research Coordinator to support the Clinical Research CORE. The CRC will implement and complete studies by assisting in regulatory documentation, participant recruitment, parental consent, and educating parents and participants.

The role includes scheduling visits, data collection, maintaining records, coordinating with sponsors, and supporting audits. Collaboration with research teams and adherence to SOPs/GCPs are essential for success.

Qualifications

• Bachelor’s degree in medical or science related field.
• At least one year of research experience.
• Effective verbal and written communication; ability to coordinate among diverse tasks.
• CRC certification or eligible to sit for exam after 2 years clinical research coordination experience.

Responsibilities

• Follows SOPs and GCPs; prepares documents for sponsor and regulatory needs; attends Investigator Meetings as assigned.
• Understands conduct of clinical studies including emergent access/compassionate use and Investigator Initiated studies.
• Manages parental permission/assent processes; schedules visits and ensures protocol compliance.
• Performs data gathering, measurements, and data integrity checks; maintains study databases; addresses sponsor queries.
• Trains nursing and ancillary staff, builds cross-department relationships to ensure protocol compliance.
• Identifies and reports Serious Adverse Events or unanticipated problems; works with research pharmacist for drug documentation.
• Maintains drug accountability records and coordinates drug administration and documentation with sponsor.
• Prepares specimens for shipment to central labs; ensures SOPs followed and proper documentation accompanies samples.
• Coordinates monitoring activities with Sponsor; completes Case Report Forms and responds to sponsor queries; prepares for audits by sponsor/IRB/FDA.
• Engages in continuous process improvement and supports audit readiness and corrective actions.
• Prepares for internal and external audits with corrective action plans.

Skills

Communication skills

Education

Bachelor’s degree in medical or science related field

Tools

Microsoft Office

Job description

Nemours is hiring a Clinical Research Coordinator (CRC). This position will support the Clinical Research CORE.

The Clinical Research Coordinator (CRC) implements and completes clinical research studies and/or clinical trials by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases.

Primary Responsibilities:

1. Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned
2. Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
3. Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
4. Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
5. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
6. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
7. Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
8. Prepares clinical specimens for shipment to central laboratories.Ensures manual of procedures is followed and applicable documentation is sent with samples
9. Coordinates monitoring activities with Sponsor’s representative(s).Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
10. Participates in continuous process improvement initiatives and implementation of outcomes
11. Prepares for internal and external audits. Prepares corrective action plans as indicated.

Qualifications:

• Bachelor’s degree in medical or science related field required;
• At least one year of Research experience required
• Effectively uses Microsoft computer software; demonstrates ability to coordinate and establish priorities among diverse tasks; effectively communicates verbally and in writing
• Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience