Clinical Research Coordinator
Company: Apidel Technologies
Location: Newport Beach
Posted on: January 22, 2023
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Job Description:
Duties: The candidate will help coordinate among Clinical
Research Coordination team members conducting investigational
clinical studies in accordance with Food and Drug Administration
(FDA) Regulations, Good Clinical Practice (GCP), and company
standard operating policies and procedures. Roles and
Responsibilities Schedule and coordinate study meetings, materials
and agendas; aligning objectives and coordinating activities
Assemble data and complete routine analyses for a variety of
reports. Enter data to records or logs and establish and maintain
files. Become an expert user/administrator and manage system level
tasks within the platform to support the Site Clinical Research
Team. Coordinate and manage version control of clinical documents.
Provide customer service to Sites; Respond to various inquiries
from the Care Team and Clinical Research Team, physicians,
telephone callers and visitors by providing information according
to guidelines or directing alerts/messages to the appropriate
person. May be required to act as liaison between investigational
sites/vendors and department management. Assemble Clinical Research
and Care Team training materials and manage workflow items to
increase education where necessary in the process. Provide guidance
and training to new administrative staff. Assist Clinical Lead with
reference searches in support of protocol development and
implementation. Identify and resolve administrative project issues.
Participate in pre study visits, Site Initiation Visits, as
appropriate. Support site initiation visit. Assist in study close
visits. Assist in the creation and updating of standardized
clinical trial tools and processes, SOPs associated with the
Patient Recruitment methodology. Collect user feedback on ease of
use, critical defects and bugs, enhancement requests and general
sentiment related to product features and overall utility of the
platform Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast paced, innovative environment while
remaining flexible, proactive, resourceful and efficient. Excellent
interpersonal skills, ability to develop important relationships
with key stakeholders, good conflict management and negotiation
skills, ability to analyze complex issues to develop relevant and
realistic plans, programs and recommendations. Essential Functions
Clinical Care: Ensure that quality patient care is delivered to all
patients on a 24 hour basis, and the unit is maintained in
accordance with professional and regulatory standards and the
philosophy and goals of the company. Perform other duties as
assigned.
Skills: Skills or Other Qualifications Knowledge of drug
development, clinical operation processes and documentation
including study start up procedures, maintenance phase, and study
close out procedures Experience with Oncology clinical studies and
clinical trial protocol development and/or implementation Knowledge
of ICH/GCP and regulatory environments including regulatory
documentation review and approval Knowledge and implementation of
the processes involved in clinical studies following Good Clinical
Practice (GCP) and the Code of Federal Regulations is required. A
broad understanding of essential study documentation is critical.
Strong communication and interpersonal/team skills. Minimal travel
required. Proficient in MS Excel, Word and PowerPoint. Knowledge of
MS project preferred. Established ability to prioritize and manage
multiple tasks simultaneously, demonstrated ability to identify and
resolve issues, and effectively manage timelines. Strong initiative
and a can do attitude, excellent organizational skills, proven
effectiveness in a quick changing, fast paced environment,
excellent people skills, and a proven record as a team player.
Education: Bachelor's degree required A minimum of 2 years
experience in clinical operations or related field required, site
CRC experience preferred (Oncology strongly preferred).
Languages:
English Read Write Speak
Keywords: Apidel Technologies, Newport Beach , Clinical Research Coordinator, Healthcare , Newport Beach, California
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