Clinical Data Coordinator Position at Moleculight
Moleculight has reached out to the department to look for recent MSc graduates. The position requires strong data analysis skills in the context of clinical trials. Details about the position can be found below.
Clinical Data Coordinator
Manager of Clinical Trials
The Clinical Data Coordinator participates in the coordination of clinical trials from the protocol review and approval stage through to activation, trial closure and follow-up. The Clinical Data Coordinator has principal responsibility for clinical trials data management, including designing data capture tools, capturing and recording clinical trials data, monitoring and promoting the quality and integrity of data, and preparing summary reports. Data management is performed in accordance with trial protocol, procedures, guidelines and professional standards of practice. All data must be complete, accurate, and timely and must be in compliance with applicable ICH-GCP, FDA and US federal code, Tri-Council regulations, and other applicable international regulations. The Clinical Data Coordinator must be able to interpret the applicable regulations in order to ensure compliance. Quality assurance procedures developed within an ISO 13485:2016 certified Quality Management System are utilized to ensure high quality data is obtained.
Duties and Responsibilities
- Ensure quality of data submitted from study sites and assure timely entry in the database, submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Establish the Trial Master File at each site including essential and non-essential documents. Ensure current copies of lab certificates, regulatory approvals, clinician’s credentials, etc., are updated in a timely manner and are in compliance.
- Ensure the conduct of the study is in compliance with the currently approved protocol/amendment(s), with current GCP guidelines and with applicable regulatory requirements.
- Ensure reported data are accurate, complete, and verifiable from source documents. Resolve any discrepancies using a traceable query process.
- Verify that Adverse Event reporting is accurate and follows GCP guidelines and applicable regulatory requirements. Escalate any reported Serious Adverse Event in timely manner.
- Document clinical trial progress to ensure completeness of documentation and data collection in adherence with the project timelines.
- Ensure collected clinical data is entered in the database in a timely manner, and extract data as required for analysis and reporting purposes.
- Keep track of Investigational Product Accountability.
- Provide support to Clinical Management Team.
- Conduct training for colleagues or study team as requested.
- Fulfill other duties as required.
Education and Experience
- Bachelor’s Degree in analytical or medical sciences such as biology, chemistry/pharmacy or physics.
- Minimum experience of 2 years in clinical research
- Experience using statistical analysis and data management software an asset
- Data managing and analysis experience and asset
- Excellent oral and written communication skills
- Excellent planning and organizational skills with effective time management
- Excellent interpersonal skills
- Meticulous, independent and capable of working with minimal supervision
- Ability to chair meetings
- Initiative and problem solving skills
- Thorough understanding of clinical research principles and processes. Ability to input into process initiatives, and procedures related to Good Clinical Practices (GCP).
- Good understanding of FDA, Health Canada, and EU Directive regulations, as well as ICH Guidelines and ISO 14155 requirements as they related to Good Clinical Practice
- Proficient knowledge of Microsoft Office, Clinical Database Management
The above information on this job description and specification has been designed to indicate the general nature and level of work performed by employees within this job. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.