***Must have experience with lots of patient interaction via phone/email, etc. Please be sure to list this on your resume
*** Must have experience handling trials with hundreds of patients. Please be sure to list this on your resume
***Must be able to start working 40 hours a week immediately
As a Clinical Research Coordinator (CRC), you will monitor the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and all applicable regulatory requirements. The CRC will provide project related support to the Project Management staff and other project team members from the proposal development through final deliverable.
The successful applicant will have the ability to manage multiple clinical trials simultaneously and have exceptional organization skills and attention to detail. The ability to work a flexible schedule, when needed, given the nature of clinical trials.
Essential Job Functions:
Review and understand the study protocol, informed consent documents and other study essential documents.
Provide support to Project Team and Clinical Operations Team.
Verifies that the investigator, staff and site facilities remain adequate throughout the trial period.
Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
Verifies the rights and well-being of trial subjects are protected.
Participate in meetings and telephone conferences, as needed.
Coordinate with Study or Project Manager to provide requested information for interim status report to sponsor.
Maintain open and ongoing communication about study status and volunteer visit status with site team members, e.g. lab personnel, volunteer support staff so that staff can plan their workday accordingly.
Update and/or create SOPs, Work Instructions, or other documents, as assigned.
Participate in meetings to include (pre-planning and clinical tracking).
Audit and maintain various reports specific to department by checking for errors, inconsistencies or discrepancies; make corrections and notify appropriate personnel of modifications.
Knowledge, Skills, Abilities:
Adequate knowledge of the clinical research process
Excellent written and verbal communication skills
Excellent organizational and time management skill
Experience in a team/matrix environment
Demonstrated ability to form strong functional relationships, maintain a positive attitude, and ability to interact with all levels of staff to coordinate and execute study activities
Ability to handle multiple priorities within multiple clinical trials
Extensive experience with Microsoft Office
4 year college graduate, preferably with a healthcare or life science degree.
In lieu of a degree, candidates with 3 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
Minimum of 1 year experience as Clinical Trial Coordinator
Understanding of inclusion/exclusion questionnaires
Strong written and verbal communication skills
Strong interpersonal skills
Expert monitoring skills to independently conduct all types of site monitoring visits
Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding)
Strong computer skills, including Microsoft Office
Comprehensive knowledge of GCP/ICH guidelines
Required GCP/ICH training certification required
Proficiency in medical terminology
Able to exercise judgment within defined procedures and practices and to determine appropriate action independently.
Exceptional attention to detail
Superior problem-solving skills
Assist in training/mentoring guidance and presentation skills.
Ability to work in a matrix environment
Exceptional time management and organizational skills
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