Sr. Clinical Research Associate

China

Research & Development

Requisition #1805000

“This job for future opportunities. There is no open position at this time. Suitable candidates will be contacted only when this position becomes available in the near future”.

For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving startup,

execution, and closeout.

Ensure site related study execution including but not limited to monitoring visits, site

evaluations, site selection, and activation, and monitoring close out and visit reports. Anticipate and identify site

issues that could affect timelines and develop alternative solutions.

• Ensure clinical trial management systems containing all sitespecific

information are maintained and kept current.

Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned

sites/study(s) according to the clinical study agreements and as per local requirements.

• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH

Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in

conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.

• Ensure audit and inspection readiness of assigned sites. Advise on preaudit

activities for GCP requirements.

Prepare and follow up site audits/inspections; provide input into the CAPA preparation.

• Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for

mentoring CRAs for various aspects of work.

• May be responsible for being the country point of contact for CROs for an assigned study.

May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.

• If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM

monitors globally. Provide consistent best practice approach to onboarding, consolidating “lessons learned”

across areas and incorporating into monitoring training materials, defining best practice training curriculum, and

maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.

• If assigned; With guidance, may serve as key point of contact in country/district for assigned study. Update

Impact/Tesla with countrylevel

information: Countrylevel

planning timelines, LSR assignments, etc.

• If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve

proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to

World Class clinical trials.

• If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review

Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides

feedback on investigators/sites on an ongoing

basis based on the site performance. Interacts and builds

professional and collaborative relationships with peers and site monitors.

• Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.

• Site Monitoring Experience: Minimum 3 years.

• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart

decision making.

• Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and

adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team

player.

• Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with

competing projects and deadlines.

• Demonstrated business ethics and integrity.

Additional Information

• Travel: Yes, 15 % of the Time

• Job Type: Experienced

• Schedule: Full-time

• Shift: Day Job

• Job Level Code: IC