Based on specific research program needs, patient facing vs. data administrative responsibilities will vary. Under direct supervision.
1.Assists with study start-up and the preparation and maintenance of all regulatory documents required by sponsor and/or regulatory agencies.
2.Assists with the preparation of protocols, informed consents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor.
3.Assists clinical research personnel in the implementation of clinical research projects.
4.Assists in the identification and recruitment of eligible study subjects.
5.Helps arrange study visits and provide instructions to study participants/families.
6.Facilitates study initiation, monitoring and close-out visits.
7.May attend investigator meetings.
8.Abstracts data from medical records and enters medical information/data onto protocol specific case report forms (CRF), study flow sheets, and other required study forms.
9.Assists in creating and updating case report forms and/or source document templates.
Coordinates reimbursement of subjects.
Maintains inventory of supplies/equipment.
Prepares lab kits and requisitions prior to visits.
Collects specimens from subjects and processes specimens as instructed.
Records data on source documents and CRF's and/or electronic web based systems.
Conducts literature searches and assists with QA/AC procedures.
Assists with adverse event monitoring and reporting.
Adheres to research protocol in compliance with applicable institutional, local and feral regulations (OHRP, FDA, GCP, etc.).
Helps triage patient questions.
Helps maintain all study documents (regulatory binders, source documents, correspondence, etc.).
Seizes opportunities to enhance knowledge of research conduct/regulations by attending relevant educational meetings/conferences.
Enter data and code in a data dashboard.
Assists in creating and updating data spreadsheets.
Timely data retrieval from medical records.
Prepare data for analysis.
Importing and exporting data in various formats.
Consenting for expedited/minimal risk studies.
Identifies patient eligibility per study criteria.
1.High School Diploma with two years research experience -or- Associates/two years of College with one year research experience or- Bachelors with no research experience.
2.Knowledge of research regulations (FDA, OHRP, GCP, etc.) preferred.
3.Strong organizational and communication skills required.
4.Familiarity with Excel database basics.
Children's Memorial Hospital