Clinical Research Coordinator
The Clinical Research Coordinator (CRC) is responsible conducting
clinical trials using Good Clinical Practice (GCP) under the direction
of the Principal Investigator.
The CRC will play a key role in the implementation of clinical trials
for stem cell derived therapies for SMA, ALS, and SCI, and directly
contribute to the gathering of good quality data.
Candidate will be responsible for coordinating Phase I-III clinical
trials, recruiting patients for studies, performing clinical duties such
as vitals, EKGs, phlebotomy, and any other clinical duties necessary to
complete studies. The CRC will be responsible for assuring that trials
are carried out in a manner consistent with all protocols and that there
is smooth, accurate progress of clinical studies from the planning and
approval stages through study completion and post-study closure.
Responsibilities
The CRC will assist in the scientific, technical and statistical
aspects of clinical research design, compile clinical research data,
provide statistical and graphic analysis of data, and participate in
drafting clinical research abstractions, presentations, and papers for
publication. The CRC will also:
- Assure that the integrity and quality of the clinical research trial
is maintained and that the trial is conducted in accordance with Good
Clinical Practice guidelines.
- Be the primary contact for the study subjects and available for
daily communication with study subjects and for communicating problems,
questions and/or clarifications to stakeholders.
- Attend the investigator's meeting, pre-study site visit, study
initiation visit, and all other study-related visits by monitors or
sponsor representatives.
- Establish study document binder to maintain complete and
accurate records of all sponsor, site, CRO, IRB/IEC correspondence and
regulatory documents pertaining to the study.
- Prepare source documents specific to the study. This includes
study folders and subject information folders, as required by the study.
- Review approved regulatory documents from the IRB/IEC, checking
for completeness.
- Set up a recruitment plan with Recruitment Services Supervisor.
Oversees recruitment and works with appropriate personnel to make
adjustments as needed.
- Meet with Recruitment Services Supervisor and Recruitment
Specialists to instruct on protocol specific phone screening
questionnaire and scheduling of potential subjects.
- Review subject screening forms prior to subject's appointment
to verify screening eligibility.
- Comply with in-house and FDA documentation requirements.
