[MedTech] Sr. Clinical Research Associate - 2306152956W

Description

Responsible for all aspects of site management and monitoring of clinical trials in Taiwan and Hong Kong. Manage interactions with all partners (investigators, site teams, internal company departments, external contractors, etc.) to facilitate successful conduct of clinical projects. Support clinical research activities.

Duties & Responsibilities:

• Assist in the conduct of assigned clinical trials (IIT/SIT) that have been determined to satisfy a medical need and/ or offer commercial potential.

• Work with clinical research management to establish the essential conditions necessary to determine the safety, efficiency, medical usefulness, and marketability of product candidates.

• Build strong professional relationships with investigators, site staffs and internal/ external service providers.

• Conduct site feasibility, selection visits, initiation visits, monitoring visits and site closure visits in collaboration with the clinical project team.

• Maintain the Trial Master File.

• Prepare and negotiate site clinical trial agreements, and manage clinical site budget and expenses.

• Prepare, review and coordinate translation of site-related documents like informed consent form, case report forms, etc.

• Preparation of regulatory and ethics submission dossiers.

• Ensure protocol-related safety reporting compliance and address and drive issue resolution.

• Monitor site recruitment and establish/discuss action plans in close collaboration with the Clinical Project Manager.

• Develop and conduct training for investigators and site staffs in the protocol, product and study-specific procedures.

• Coordinate activities to ensure compliance with protocol, GCP, overall clinical objectives as well as company policies and SOP.

• Manage trial product inventory, shipment and storage, and ensure accountability and traceability.

• Ensure that imaging and/ or laboratory samples are collected, handled and shipped according to protocol requirements.

• Ensure that safety reporting of adverse events is completed within required time periods.

• Manage external vendor services for assigned clinical sites.

• Identify issues which affect clinical trial progress and quality, and develop solutions and/ or take action to resolve/ prevent them

.

• Deliver projects according to expected targets, budgets and quality standards.

• Monitor and report to clinical management teams on clinical trial progress, performance and plan, including subject recruitment and retention, monitoring activities, data completeness and quality, and site compliance.

• Assist in the organization and conduct of internal and external stakeholder meetings, as required.

• Collaborate with Taiwan & Hong Kong partners to plan and execute medical affairs activities.

• Set up, maintain and update regional clinical research IT systems

• Support clinical research management in clinical research activities and initiatives

QUALIFICATIONS & EXPERIENCE

• Master’s degree or above, preferably in pharmacy, life sciences or equivalent field.

• 2-4 years relevant work experience in Clinical Research in pharmaceutical, medical devices or biotechnology field.

• At least 2 years experience in clinical research monitoring and site management.

• Demonstrated capabilities in site management and monitoring within timelines and allocated resources.

• Prior experience in medical device trials, clinical project management and clinical research trial management system maintenance will be an asset.

• Basic medical/ therapeutic area knowledge and medical terminology preferred.

• Well organized and be able to work in a cross-functional environment required.

• Strong analytical and problem-solving skills.

• Able to take initiative and work as a team or independently with minimal supervision as required.

• Effective interpersonal, oral and written communication skills both English and Mandarin.

• Willingness to travel (domestic & abroad) with occasional overnight stay aware from home.

Qualifications

see above

Primary Location Asia Pacific-Taiwan-Taipei-Taipei

Organization Johnson & Johnson Medical Taiwan Ltd. (8582)

Job Function Clinical Development & Research & Non-MD

Req ID: 2306152956W