Lead Clinical Research Associate, Selution (Remote)

Overview :

The Senior (Sr.) Lead Clinical Research Associate (CRA) reports to the Clinical Monitoring Manager responsible for site management oversight, with an emphasis on leading monitoring activities, training of CRAs and site staff, oversight of clinical CROs and supporting various study management and clinical quality (e.

g. audit readiness) activities. The Sr. Lead CRA ensures protocol requirements, laboratory collections, imaging collections, regulatory requirements, and relevant clinical research guidelines are adhered to and that project timelines are met.

The Sr. Lead CRA will interact heavily with the Clinical team, cross-functional internal teams, clinical vendors and with healthcare professionals.

Clinical research is the top priority for Cordis, and this role will be directly involved in the success of the organization in improving patient care.

Responsibilities :

Accountable for the monitoring of assigned sites

Responsible for working through other CRAs by leading, mentoring and coaching

May be responsible for co-monitoring as needed

Ensure high quality of monitoring in-house and externally

Help drive the team to ensure study deliverables are met with efficiency and quality

Assisting with training site and internal personnel, including preparing and maintaining study documents

Overseeing clinical trial site setup and activation activities

Manage cross-functional communication and planning related to monitoring for each of the clinical IDEs

Key contributor to the Clinical Monitoring Plan, monitoring tools, and training materials

Due to the high visibility of these projects, effectively communicate and plan the monitoring strategy

Assist Monitoring Manager with monitoring report review

Assist in the development of CRFs and edit checks

Ensuring that protocol requirements, regulatory requirements, and clinical research guidelines are followed

Develop monitoring metrics to evaluate site performance

Responsible for device accountability for sites as well as support the device reconciliation process for the study.

Ensuring the Trial Master File is maintained and ready for inspection

Providing insights into trial activities, such as trends in enrollment, protocol compliance, and data quality

Assisting with identifying and resolving problems, including actions to prevent reoccurrences

Escalates issues with suggested plans of action as needed

Ensure monitoring timelines are on track for each of the studies in relation to the PMA submission timelines

Help execute BIMO audit readiness planning in relation to monitoring of the IDE trials

Performs vendor qualifications, study-wide quality checks and audits, as needed.

Oversees and implements process improvement activities

Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, Good Clinical Practices, ISO 14155, Regulatory Agency requirements

Key Interactions

Key interactions with clinical leadership (e.g. Monitoring Manager, Sr. Dir Clinical Operations, SVP Clinical & Regulatory), study leaders and managers, CRAs, physicians and site personnel, CROs, and outside vendors

Qualifications :

Bachelor’s degree is required

10+ years of experience monitoring

Experience as a lead CRA

Required knowledge and experience monitoring medical device trials and cardiovascular space

Experience overseeing CRO CRAs

Travel is required (50%)

Competencies & Skills

Precise, Rigorous, Detail-Oriented

Team Leader, ability to inspire and support a team

Strong written and oral communication skills

Highly organized, outcome-oriented, self-motivated performance

Supportive, keen to promote quality through example and continuous support.

Critical-thinking and problem-solving skills

Ability to make independent decisions

Excellent interpersonal skills ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills

Skill in prioritizing workflow to meet deadlines

Capable of working across multiple time zones including Europe

Fluent in English