For one of our clients, a medical device company located in Machelen, we are recruiting a Clinical Study Coordinator.
This role is open for junior candidates with a first internship experience in clinical research or within a medical device/pharma company, who have a taste for administrative tasks.
Presence at client's location (Machelen) is required.
Job Description
As Clinical Study Coordinator (CSC), you provide administrative support to the study team throughout the study. This is achieved by ensuring timely filing of study documents, creation, and shipment of patient and regulatory binders as well as study materials. AS CSC, you work closely together with the inhouse CRA within Site Operations.
By providing this administrative support, you contribute to ensuring site audit readiness. Upon receipt of study documents you perform an initial quality check to ensure compliance to study protocol, domestic and international Good Clinical Practices and company Standard Operating Procedures.
As CSC, you can assist in the preparation of study committee meetings by setting up the meeting venue, coordinating the travel and preparing the necessary documents.
You will also work with the core labs to track and obtain the reviewed data, as required per protocol.
Responsibilities
1. You are responsible for Study Document Management
- At study start-up:
- you create the table of content for the Study Site Regulatory Binder Template in collaboration and under the supervision of study management.
- you prepare the Study Site Regulatory Binder and Patient Binder with all study approved documents.
- You perform quality check on Site specific Regulatory and Patient binders
- You pack and send binders to colleagues and/or study sites.
- You perform quality check and filing of the following documents:
- Site and sponsor correspondence
- EC submission packages
- Document uploads in the Trial Master File
- You contribute to and assist with site audit readiness
- You track submission and correspondence on essential study site documents
2. You provide support to inhouse CRAs and Study team
- You act as point of contact within the CSC team for the assigned Business Unit.
- You attend study related meetings
- You maintain records of investigational devices for all assigned regulated studies, if applicable in the region.
- You facilitate the order and release of clinical IDE device inventory, if applicable in the region.
- You assist with sending of study communication such as newsletters and mailings to sites.
- You support and track shipment of project related equipment/data between sites, sponsor and core labs.
- If necessary, you provide logistic support for meetings such as scheduling a room and teleconference, create an agenda and write meeting minutes.
- You assist Inhouse CRA team with site activation and closure activities.
3. You are able to handle multiple tasks in a timely manner while meeting assigned deadline.
- You have the ability to notify supervisor if timelines appear to be at risk so that more resources can be added to assist and still meet deadlines.
4. You communicate and collaborate with all levels of employees, customers, contractors, and vendors.
Requirements
- Any relevant degree
- First internship experience in clinical research experience or within a medical device or pharmaceutical industry or within a clinical/hospital environment.
- Proficient in operating a personal computer and in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software.
- Strong organizational skills and attentiveness to detail.
- Fluency in English and in any other European language.
- Able to exchange straightforward information, ask questions, and check for understanding.
- Existing right to work in Europe required
Benefits and contract information
- A balanced salary package based on your skills and experience
- Office-based position : 5 days/week in the office (1 day of homeworking/week after 3 months)
- Permanent contract
