Clinical Research Coordinator 1

Worldwide Clinical Trials•San Antonio, TX

3d•$24 - $48•Onsite

About The Position

The Clinical Research Coordinator 1 (CRC 1), under the guidance of the Clinical Research Coordinator Supervisor or designee, and each clinical trial’s Principal Investigator, is responsible for assisting with assuring 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 and ICH guidelines as applicable.

Requirements

Bachelor’s Degree (preferably in the field of Life Sciences or Health) or 1-2 years of clinical research experience.
At least 18 months experience as a Assistant Clinical Research Coordinator
Excellent written and oral communication skills.
Ability to understand complex written and oral instructions.
Basic computer knowledge and applications required for generation of business correspondence and preparation of regulatory and other study documents.
Strong interpersonal skills.
Excellent attention to detail.
Exceptional organizational skills.
Ability to set and meet deadlines with high quality work.
Knowledge of the clinical research process, including Good Clinical Practices, informed consent process, drug accountability procedures, and IRB submission and reporting.

Responsibilities

Represents Worldwide Clinical Trials (WCT) in a professional manner (verbal written and in appearance) when interacting with subjects, outside vendors and fellow employees.
Reviews study protocol.
Performs quality checks on source documents specific to the study, per SOP review must occur in a defined timeframe.
Attends in-house protocol meeting to review study-related procedures, staffing and visit flow and sponsor SIV.
Responsible for giving subject instructions at check-in and serves as the primary contact for subjects by being available to handle study-specific questions, concerns, or events.
Responsible giving subjects’ safety orientation upon checking into the Clinic.
Obtains and documents adverse event data on appropriate forms.
Payment to subjects.
Responsible for completing continuous training assignments.
Covers OPV, checkouts and check-ins, dosings.
Tracking infractions to in-house.
Responsible for scheduling clinical lab reports as ordered by physician.
Conducting study check-ins.
Back Up contact for subjects.
Responsibilities for t-shirt allocation.
Answering queries and laundry schedule.
Other duties as assigned.
Possible mental demands include, but are not limited to: reading, math, intense concentration, verbal communication, written communication, attention to detail, multiple tasks, frequent interruptions, and fluctuation in work load.
Possible physical demands include but are not limited to: occasional lifting and carrying of objects weighing 5-50 lbs.; hearing; seeing; gross and fine motor use of upper extremities; kneeling; walking; standing; leaning over for extended periods; squatting; eye strain/fatigue; climbing; pushing; pulling; reaching; and exposure risk to potentially infectious blood and/or body fluids, fumes or chemicals.
CRC 1 will be delegated tasks by the Clinical Research Coordinator 2 or Supervisor.
There will be times when an adjustment in work hours, to include weekends, is necessary.
The Clinical Research Coordinator 1 will be the secondary contact for the study subjects.
The Clinical Research Coordinator 1 is responsible for communicating problems, questions and/or clarifications.
These communications can include, but are not limited to, protocol clarifications, protocol deviations and adverse event reporting.
The Clinical Research Coordinator 1 will communicate all problems, questions and/or clarifications to the CRC 2, CRC Supervisor and/or Clinical Study Manager for their direct communication with the Sponsor.