Description of Roles and Responsibilities
Acts as primary site contact and site manager throughout all
phases of a clinical research study, taking overall responsibility of
Develops strong site relationships and ensures
continuity of site relationships through all phases of the trial.
Performs clinical study site
management / monitoring activities in compliance with ICH-GCP, Sponsor SOPs,
Local Laws & Regulations, Protocol, Site Monitoring Plan and associated
Gains an in-depth understanding of the study
protocol and related procedures.
Coordinates & manages various tasks in
collaboration with other sponsor roles to achieve Site Ready.
Participates & provides inputs on site
selection and validation activities.
Performs remote and on-site monitoring &
oversight activities using various tools to ensure :
Data generated at site are
complete, accurate and unbiased
Subjects’ right, safety and
well-being are protected
Conducts site visits including but not limited
to validation visits, initiation visits, monitoring visits, close-out visits
and records clear, comprehensive and accurate visit & non-visit contact
reports appropriately in a timely manner.
Collects, reviews, and monitors required
regulatory documentation for study start-up, study maintenance and study
Communicates with Investigators and site staff
on issues related to protocol conduct, recruitment, retention, protocol
deviations, regulatory documentation, site audits / inspections and overall
Identifies, assesses and resolves site
performance, quality or compliance problems and escalates per defined CRA
Escalation Pathway as appropriate in collaboration with CRM, PLM and RCPM.
Manages and maintains information and
documentation in CTMS, eTMF and various other systems as appropriate and per
Contributes strongly to CRA team knowledge by
acting as process Subject Matter Expert (SME), sharing best practices, making
recommendations for continuous improvement and providing training as
appropriate / required.
Supports and / or leads audit / inspection
activities as needed.
Mentors / buddies junior CRAs on process / study
requirements and performs co-monitoring visits where appropriate
Requirements : Expeirence
Min. 4 years of direct site management (monitoring) experience in a bio / pharma. / CRO.
B.A. / B.S. preferred with strong emphasis in science and / or biology
Ability to travel domestically and internationally approximately 65%-75% of working time.
Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP / ICH & country clinical research law & guidelines.
Excellent understanding of Global, Country / Regional Clinical Research Guidelines and ability to work within these guidelines.
Demonstrated ability to mentor / lead
Hands on knowledge of Good Documentation Practices
Proven Skills in Site Management including independent management of site performance and patient recruitment
Demonstrated high level of monitoring skill with independent professional judgment.
Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
Able to work highly independently across multiple protocols, sites and therapy areas.
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus.
Works with high quality and compliance mindset