Senior Clinical Research Associate Ii

2+ years

Not Disclosed

Remote, USA

10 Nov. 4, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Research Associate II
Job Location: Poland (Home-based position, any location in Poland considered)

Job Overview:
The Senior Clinical Research Associate II monitors investigational sites to ensure subject safety and provide high-quality data review and reporting in compliance with Caidya and/or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, ISO14155, and other applicable regulations. This role builds, manages, and supports strong site relationships while serving as a liaison between the Sponsor and assigned sites.

Job Duties and Responsibilities:

Provide support to the Project Team and Clinical Operations Team.
Maintain a strong working knowledge of protocols and Monitoring Plans for assigned projects.
Demonstrate strong written and verbal communication skills.
Serve as the primary contact for assigned research sites.
Verify that the investigator, staff, and site facilities remain adequate throughout the trial period.
Schedule and conduct pre-study visits, initiation visits, interim monitoring visits, and close-out visits according to the Monitoring Plan.
Ensure research sites conduct studies according to protocol requirements or investigational plans and applicable regulations and guidelines.
Verify the rights and well-being of trial subjects are protected.
Reconcile site regulatory binders to ensure collection and completeness of regulatory documents.
Collect and ensure completeness of all essential regulatory documentation from sites from study start-up through close-out.
Support translations of essential documents as needed.
Assist in the submission of trials to IRB/IEC and regulatory authorities.
Verify that written informed consent was obtained before each subject’s participation in the trial.
Ensure that the investigator is enrolling only eligible subjects.
Perform source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan, ensuring accurate and complete data with documented corrections by authorized site staff.
Verify the quality of all recorded data, issuing and ensuring timely resolution of all data queries remotely or at the investigator site.
Perform Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
Verify and support the recording and reporting of adverse events/serious adverse events, ensuring all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.
Ensure that sites have sufficient project-specific supplies.
Manage investigative sites regarding trial conduct and motivate sites to meet study goals.
Communicate deviations from the protocol, SOPs, and/or GCP to the investigator and project management team, taking appropriate action to prevent recurrence.
Deliver high-quality written trip reports, confirmation, and follow-up letters within timelines of SOPs and Monitoring Plans.
Participate in site audits, as requested.
Conduct site and study feasibility assessments as needed.
Provide input into study documentation and monitoring worksheets.
Uphold confidentiality agreements with all clients and colleagues outside Caidya Clinical Research.
Pay attention to signals of fraud, misconduct, and escalate per Caidya SOP.
Work according to the Caidya Quality Management System and actively participate in providing feedback and suggesting improvements to current processes.
Adhere to project-specific timelines and budget agreements established with the sponsor, accurately documenting time spent per project in the Caidya time allocation system.
Perform trip report review, management, resolution, and escalation as needed.
Conduct project co-monitoring visits and team training as required.
Facilitate team calls and Sponsor calls when necessary.
Provide project-specific performance feedback.
Serve as site contact for protocol clarifications and subject enrollment.
Manage Protocol Deviation documentation, tracking, and escalation.
Relate project status and issues to the Project Manager and/or CRAs.
Serve as Sponsor contact for monitoring/site issues.
Assist the Project Manager with coordination and management of the project budget, grant administration, and project invoicing.
Attend and participate in team teleconferences/meetings, providing mentoring and training.
Participate in relevant trial meetings, such as Kick-off, Investigator, and Monitor meetings, and provide support as requested.
Demonstrate flexibility and adaptability.
Assist the project team in the development of monitoring guidelines and tools.
Proactively identify, manage, escalate (as needed), and resolve site issues effectively and independently.
Provide support to the Project Team.
Conduct SOV and QAV assessments as needed.
Provide mentorship, training, and direction to Clinical Research Associates when required.
Perform other duties as assigned by the Clinical Operations Manager/Project Manager as per project-specific requirements.
May participate in delivering the Clinical Monitoring portion of a bid defense presentation.

Supervisory Responsibilities: None

Job Requirements:

Education

4-year college graduate, preferably with a healthcare or life science degree.
In lieu of a degree, candidates with 4 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.

Experience

Minimum of 6 years of experience in on-site monitoring of clinical studies.
Monitoring experience in complex therapeutic indications across multiple therapeutic areas.
Experience in all areas of monitoring (on-site, remote, etc.).

Skills/Competencies

Strong written and verbal communication skills.
Strong interpersonal skills.
Expert monitoring skills to independently conduct all types of site monitoring visits.
Good documentation skills; proficiency in English and the local language in the area of activity (reading, writing, understanding).
Strong computer skills, including Microsoft Office.
Comprehensive knowledge of GCP/ICH guidelines.
Proficiency in medical terminology.
Ability to exercise judgment within defined procedures and practices and determine appropriate action independently.
Strong attention to detail.
Superior problem-solving skills.
Ability to assist in training/mentoring guidance.
Strong presentation skills.
Ability to work in a matrix environment.
Exceptional time management and organizational skills.

Capabilities

Ability to drive an automobile and have a valid driver’s license, if applicable.
Valid passport required for international business travel.
Ability to travel up to 80%.