#Clinical Research Associate (CRA) - ISR
Who are we?
We are here to improve the lives of patients through innovative technologies. We're a rapidly growing inter-disciplinary team of professionals passionate about developing disruptive technologies that use the body’s immune response in order to empower physicians to make better informed decisions. Our first goal is to address one of the most frequent medical encounters – the fever encounter (www.me-med.com).
Who are we looking for?
If you're a highly motivated team player, with a passion for realizing game changing medical products that can impact patients, we would love to hear from you.
We are seeking a top notch experienced Clinical Research Associate to join our medical team and support MeMed’s clinical and medical activities.
Responsibilities include participating in various clinical studies aspects and supporting the day-to-day activities of the clinical team of the company.
We seek a team player that enjoys working in a dynamic and creative environment. The candidate needs to be detail oriented, possess problem solving capabilities and with superb communication skills.
Primary Job Responsibilities
- Conducting site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation, in large multi-center studies both in Israel and abroad.
- Acting as the frontline liaison between Me-Med and the various sites, to ensure successful collaboration and achieving goals.
- Maintaining day-to-day communication with different clinical site personnel
- Managing assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and procedures.
- Conducting continuous monitoring activities (onsite and remote). Implementing site management activities to ensure compliance with protocol, GCP, regulations, processes to secure data integrity and patient safety.
- Documenting monitoring activities according to company procedures.
- Facilitating the preparation and collection of site and country level documents.
- Managing protocol administrative related tasks and study training activities
- Evaluating the quality and integrity of site practices.
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Communicating with a variety of colleagues and customers.
- Developing aids to allow sites to proceed expeditiously (e.g. newsletters, flow charts) and advance the program overall (metrics, monitoring tools).
- Ensuring timely submission of study documentation to central and local IRB, IRB status reports, and IRB modifications.
- Participating in audit readiness activities for monitoring and site related activities as required, to ensure the implementation of corrective actions within specified timelines.
- Assisting with preparations for FDA regulatory submissions.
* The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
Skills and Competencies
To succeed in this role, you will need the following skills/experience:
- Excellent organizational and planning skills
- Detail oriented, with an ability to multitask and prioritize in a fast-paced environment
- Good problem-solving abilities, flexibility, team player with excellent interpersonal and presentation skills
- Proficient use of standard MS Office applications (Word, Excel and PowerPoint)
- Excellent English proficiency (oral and written)
- Availability to travel abroad
Education, Experience, and Training Requirements
- Sc. or higher qualification within Life Science, Pharmacology, or a relevant discipline.
- At least 1 year as a CRA – including involvement in IRB submissions, monitoring and Managing sites and trials.
Location & Travel:
MeMed is located at Haifa, Israel. The role Involves traveling to different sites.