Study Start-up Specialist I/ii, Costa Rica

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Proficiency in English, both verbally and written are necessary.

Please submit resume in English.

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.

KNOWLEDGE, SKILLS & ABILITIES:
- Knowledge of clinical research process related to study start-up and medical terminology- A basic understanding of Regulatory and Central/Local ethic submission processes for assigned countries- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members- Excellent organizational and interpersonal skills- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities- Ability to manage multiple competing priorities within various clinical trials- Working knowledge of current ICH GCP guidelines and applicable regulations- Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor administrative staff- Excellent verbal and written communication skills required in local language for assigned countries- Ability to work independently, prioritize and work with a matrix team environment is essential- Working knowledge of Word and Excel is required- Ability to travel periodically if needed

PHYSICAL REQUIREMENTS:
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech- Extensive use of keyboard requiring repetitive motion of fingers- Regular sitting for extended periods of time

MINIMUM RECRUITMENT STANDARDS:
- Bachelor’s degree (or equivalent), preferably in science or related field and 6 months - 4 years relevant experience. Specialist I needs at least 6 months experience and Specialist II needs at least 1.5 years experience related to study start-up and maintenance activities.- Equivalent combination of education, training and experience

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