Clinical Research Associate (Freelance)

For an international pharmaceutical company, we are looking for a freelance clinical research associate in Israel (you will work hybrid - from your home office + site visits).

You will be responsible for managing clinical activities at study sites conducting studies for the Medical Devices group, as well as, fostering strong, productive relationships with colleagues within the Medical Devices Group. Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between the clinical study team and study site personnel for the specific clinical projects.

Job description (examples of tasks to be done):

Clinical Study Site Management Tasks

● Ensures that all work related activities, and decisions embody the values.

● Verify safety and well being of study subjects are maintained for assigned study sites.

● Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.

● Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.

● Accountable for study site performance, and providing high quality data according to overall project timeline.

● Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.

● Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.

● Responsible for supporting patient recruitment and retention activities.

● Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.

● Assists with internal communication of important clinical data and events.

● Support organization of Investigator and other study training meetings, if required.

● Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.

● Understand business value of clinical projects and balances overall business objectives and functional needs.

● May be involved in other tasks to support Clinical Operations and Operating Company as needed.

● Support the implementation of new clinical systems/processes.

● Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.

Administrative Tasks

● Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and policies and Procedures of the Health Care Compliance Program and Code of Conduct.

● May be asked to provide additional support to Clinical Operations staff, as needed.

Requirements:

● Typically requires Bachelors degree with at least 2 years of relevant experience; Masters or PhD/MD/PharmD with at least 1 year of relevant experience.

● Requires experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and Power Point).

● Previous clinical research experience required.

● Previous medical device monitoring or equivalent experience required.

● Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.

● Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).

● Clinical/medical background – a plus.

● Working proficiency in English.

● You are able to perform site visits in Israël.

You will be recruited via Randstad Professionals Belgium, who is in the lead of a team of 11 CRA's and approximately 130 contractors in other life science discplines working for an international pharmaceutical company.

You can work on this assigment on a freelance base only. Rate is to be discussed in the interviewing process as well as availability.

Applications:

Apply online with your resume and motivational letter. When your background matches the requirements, we will plan a meeting to discuss this opportunity further. Afterwards, there will be a matching interview with the client. You will be contracted as a freelancer and invoice the worked hours / expenses for site visits on a monthly base.