Senior Clinical Research Associate

About you:

• You are calm, thoughtful, and responsive when things don’t go as planned.
• You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
• You find quick and creative ways of overcoming difficulties.
• You have an impeccable eye for detail.
• You identify potential study risks and propose solutions on how to mitigate them.
• You take responsibility in the quality and outcomes of your work.
• You are adept at handling conflict by using tried and true resolution strategies.

How we will keep you busy and support your growth:

You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Senior CRAs handle appropriately sized clinical trials, and support Project Managers with trials that are larger in scope. You will also have the opportunity to train and mentor junior staff members. You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.

Qualifications:

Minimum Required:

• 4-year college degree or equivalent experience

Other Required:

• 3+ years of CRA experience within the CRO or pharmaceutical industry;
• Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions)
• Experience in biopharma or relevant therapeutics areas.
• Fluency in Serbian, English and Bulgarian languages.

Preferred:

• Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline
• Study start up activities experience
• Experience with Phase I studies
• For Senior CRAs, understanding of financial management

Please, apply in English.