Experienced CRA II/Sr CRA - US Northeast Region - Multiple Therapeutic Areas Available

Overview

Clinical Research Associate (Level II) responsible for performing and coordinating all aspects of the clinical monitoring and site management process, conducting remote or on-site visits to assess protocol and regulatory compliance.

What you'll do

• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions.
• Ensure data accuracy through SDR, SDV and CRF review through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of identified issues and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Share responsibility with other project team members for issue and finding resolution, investigating and following up on findings as applicable.
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Perform trial close out and retrieval of trial materials.
• Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations, and conduct on-site file reviews as per project specifications.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensure study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitate effective communication between investigative sites, the client company and the project team through written, oral and/or electronic contacts.
• Respond to company, client and applicable regulatory requirements, audits and inspections.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions.
• Contribute to other project work and process improvement initiatives as required.

What you'll need

• Bachelor's degree in a life sciences related field, or a Registered Nursing certification or equivalent, and relevant formal academic / vocational qualification.
• Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor), or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• 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 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 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 required.
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Details

• Location: Remote, Massachusetts, USA; standard Monday to Friday schedule.
• Frequent travel, generally 60-80% but more for some individuals, including frequent drives to site locations and possible extended overnight stays.
• Work performed in an office, laboratory, clinical and/or home office environment.
• Exposure to biological fluids and potentially infectious organisms; personal protective equipment required.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.
• Variable annual bonus may be available based on company, team and/or individual performance.