Clinical Research Study Coordinator
On behalf of our client, Procom Services is searching for a Clinical Research Study Coordinator to join their team in Chapel Hill, NC. The primary purpose of this position will be to run all aspects of the assigned clinical trials. IRB submissions, recruitment, working with investigators as well as the patients.
Clinical Research Study Coordinator Job Description
Perform independent and dependable work in preparation and coordination of study submission to IRB and other appropriate committees following regular deadlines.
They will provide draft IRB, Sponsor and other response to the PI for approval.
They will respond on behalf of the PI when appropriate
Communicate with study staff, IRB, sponsors, domestic and international study partners in a courteous and professional manner; Meet with study sponsor representatives as needed.
Attend IRB, study sponsor, or any other meeting in place of the PI
Prepare informed consent forms that follow appropriate regulation and meet sponsor requirements
Address queries and memos from IRB and other committees create draft response to query’s for PI approval
Maintain and organize electronic and paper regulatory documents, study files and patient binders.
Perform Quality Assurance/Quality Control of Study files
Track and enter regulatory submissions using electronic databases and prepare reports within the databases.
Respond to all queries and adverse events in a timely manner.
Will be initial contact for all adverse events for their studies
See clinical trial patients, follow up with phone calls and make sure all protocols are followed. Will also be responsible for screening and recruitment of clinical trial patients
Communicate for themselves and on behalf of the PI potential issues to regulatory supervisor, study team members, and investigators
Assist other staff members in completion of work in a team oriented fashion
Complete other regulatory duties as assigned.
Communication, Teamwork and Compliance
Employee uses effective verbal and written communication to accomplish tasks
Coordinator must have the technical ability to apply the knowledge of research principles when collecting, editing, analyzing the data and reporting data/information related to the study.
The Coordinator will be required to have general computer and technical knowledge as well as an understanding of patient input data bases.
Requires ability to identify discrepancies in database information.
Coordinator must be able to problem solve and implant new systems to help make Center more effective. This type of work requires extreme organization and attention to detail.
Coordinator will support research, develop programs and policies for the Center.
Coordinator must be able to work as a productive member of a team by helping develop solutions to meet group needs as well as the structure of the team.
Coordinator will have the ability to serve as a team leader.
Skills include working effectively with patients, medical faculty and staff, ability to understand and implement protocols and teach them to clinic personnel.
Requires ability to develop a flexible work schedule, organized and able to implement clinic clinical trials based on FDA and good clinical practice guidelines and work independently.
Experience in research is required.
Knowledge of research principles and methods to interpret, and coordinate the collection and analysis of data/information related to the research.
Clinical Research Study Coordinator Mandatory Requirements
Prior experience in Clinical Trials.
Nursing degree preferred, specifically with a focus in Oncology.
Clinical Research Study Coordinator Start Date
ASAP
Clinical Research Study Coordinator Assignment Length
6 months (possible extension/hire)