FSP_Principle Clinical Research Associate (Sponsor: Roche) ─ with Sign-on Bonus

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

FSP_Principle Clinical Research Associate (Sponsor: Roche) ─ with Sign-on Bonus

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.

Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.

Assess investigational product through physical inventory and records review.

Documents observations in reports and letters according to timelines using approved business writing standards.

Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.

Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.

Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.

Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.

Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.

Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).

Education and Experience:

University degree in a science related field

at least 7 years  of independent monitoring experience in clinical development phases I-III

Understanding of ICH-GCP, KGCP requirements

Fluency in English

Knowledge, Skills and Abilities:

Proven clinical monitoring skills

Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents

Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving

Ability to manage Risk Based Monitoring concepts and processes

Good oral and written communication skills, with the ability to communicate effectively with medical personnel

Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues

Good organizational and time management skills

Effective interpersonal skills

Attention to detail

Ability to remain flexible and adaptable in a wide range of scenarios

Ability to work in a team or independently as require

Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software