Sr. Clinical Research Associate

About the role

To support 1-3 protocols in the cardiovascular/electrophysiology medical device space.

The ideal candidate will have cardiovascular medical device monitoring experience- however, cardiovascular/electrophysiology pharma monitoring experience will be considered.

3 years of monitoring experience required.

A Bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.

Responsibilities

• To support 1-3 protocols in the cardiovascular/electrophysiology medical device space.
• The ideal candidate will have cardiovascular medical device monitoring experience- however, cardiovascular/electrophysiology pharma monitoring experience will be considered.
• 3 years of monitoring experience required.
• A Bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
• Ability to work independently and manage multiple priorities in a dynamic environment.
• A well-executed plan for communication with the study teams and sites.
• Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports.
• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
• Candidates must have complex cardiac experience within the past 5 years, preferably in electrophysiology and / or devices.
• Examples provided for reference, not an all-inclusive list:
• Best-device examples: Ablation catheters, pacemakers, ICDs, LAACs, stents, valves
• Good-pharm examples: Rhythm disorders, myocardial infarction
• Not sufficient: Hypertension, hyperlipidemia
• A plus:
• CRA training or bridge program through a reputable organization / employer
• Clinical background

Requirements

• 3 years of monitoring experience required.
• A Bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
• Ability to work independently and manage multiple priorities in a dynamic environment.
• A well-executed plan for communication with the study teams and sites.
• Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports.
• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
• Candidates must have complex cardiac experience within the past 5 years, preferably in electrophysiology and / or devices.
• A plus:
• CRA training or bridge program through a reputable organization / employer
• Clinical background

Qualifications

• A Bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
• Ability to work independently and manage multiple priorities in a dynamic environment.
• A well-executed plan for communication with the study teams and sites.
• Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports.
• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
• Candidates must have complex cardiac experience within the past 5 years, preferably in electrophysiology and / or devices.
• A plus:
• CRA training or bridge program through a reputable organization / employer
• Clinical background

Skills

• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
• Ability to work independently and manage multiple priorities in a dynamic environment.
• A well-executed plan for communication with the study teams and sites.
• Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports.
• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
• Candidates must have complex cardiac experience within the past 5 years, preferably in electrophysiology and / or devices.
• A plus:
• CRA training or bridge program through a reputable organization / employer
• Clinical background

Benefits

• Retirement savings plan
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
• Transit spending account
• Paid sick leave under the applicable state or local plan

Pay

Details TBD

Schedule

Regional travel flexing up to 75%