Clinical Research Coordinator (CRC)
Company: Spencer Ogden Ltd
Posted on: February 25, 2021
Our culture is founded on five core values Quality, Integrity,
Discovery, Partnership and Professionalism. An Organization where
people's talents can be challenged, and their efforts recognized
and rewarded. We align our actions with the values and behaviors as
a full set - all are equally critical to our success. Unleash your
talents and apply the new, now with a career that disrupts and
transforms the clinical research industry. 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
- Ensure subjects meet all inclusion/exclusion criteria and have
been properly consented prior to screening and enrollment into any
- 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
- Oversee and maintain records of the proper receipt, storage,
distribution and any shipments or transfer of investigational
- Attend and facilitate sponsor visits including PSSVs, SIVs,
IMVs, COVs and audits.
- Communicate with IRBs, Sponsors, CROs, and outside
- 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
- Ability to organize and prioritize tasks
Keywords: Spencer Ogden Ltd, Paterson , Clinical Research Coordinator (CRC), Healthcare , Paramus, New Jersey
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