Senior Clinical Research Associate

Caraway Therapeutics, Inc.; United States; À distance; USD 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Remote work

Résumé du poste

Caraway Therapeutics, Inc. in the United States is seeking a Clinical Research Associate to lead site management for assigned protocols and sites, acting as primary site contact, and expanding the territory for clinical research.

You will conduct site visits, ensure data quality and patient safety, manage CTMS/eTMF systems, collaborate with sponsor teams, and travel internationally up to 50% while enjoying a remote work option.

Qualifications

• Minimum 3 years direct site management (monitoring) experience in bio/pharma/CRO.
• Proven skills in site performance management and patient recruitment.
• Fluent in English and local language with excellent communication skills.
• Ability to travel domestically and internationally ~50% of time and hold a valid driving license.

Responsabilités

• Conduct site visits (validation, initiation, monitoring, close-out) and write reports.
• Ensure data generated at site are complete, accurate and unbiased.
• Protect subjects' rights, safety and well-being.
• Monitor compliance with ICH-GCP, SOPs, and Site Monitoring Plan.
• Coordinate tasks with sponsor roles and communicate with Investigators.
• Manage CTMS/eTMF systems and promote learning across the team.
• Follow country strategy defined by Country Director.

Connaissances

Site management

Data analysis

Communication

Travel readiness

Formation

M.A./M.Sc in medical/bioscience

Outils

CTMS

eTMF

Description du poste

Job Description

If you want to:

• Join a multi-award-winning leading biopharmaceutical company
• Be part of growing team of Clinical Research Associates
• Use new technology and smart monitoring tools
• Have flexibility of work and good work-life balance

On this position you will be accountable for performance and compliance for assigned protocols and sites in a country. You will act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites and actively develop and expand the territory for clinical research, finding and developing new sites.

Your key responsibilities:

• Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits) and record clear, comprehensive and accurate visit & non-visit contact reports.
• Ensure by monitoring activities that: Data generated at site are complete, accurate and unbiased.
• Subjects' right, safety and well-being are protected.

• Perform clinical study site management/monitoring activities in compliance with local regulations, ICH-GCP, Sponsor SOPs, protocol, Site Monitoring Plan and associated documents.
• Coordinate and manage various tasks in collaboration with other sponsor roles.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify and assess site performance, quality or compliance problems in collaboration with CRA Manager, Project Manager, Therapeutical Area Head and Country Director as needed.
• Manage and maintain clinical trial systems such as CTMS, eTMF, etc.
• Share the knowledge and best practices, nurture a learning culture to boost efficiency and competence of our team.
• Follow the country strategy defined by Country Director.

You should apply if you have:

• Min. 3 years of direct site management (monitoring) experience in a bio/pharma/CRO.
• Proven skills in site management, including management of site performance and patient recruitment.
• Good IT skills, ability to learn and operate new IT applications.
• Ability to understand and analyse data/metrics.
• Capable of managing complex issues, works in a solution-oriented manner.
• Fluent in English (verbal and written) and local language, excellent communication and presentation skills.
• Good understanding and working knowledge of clinical research, local regulations, ICH-GCP.
• M.A/ M.Sc degree with strong emphasis in medical/bioscience background.
• Ability to travel domestically and internationally approximately 50% of working time. Expected travelling ~2-3 days/week.
• Valid driving license.

Additional location(s) Compensation Information:

Required Skills:
Clinical Data Management, Clinical Development, Clinical Reporting, Clinical Research Operations, Clinical Research Organizations (CRO) Management, Clinical Study Management, Clinical Trial Management, Clinical Trials Monitoring, Drug Development, Good Clinical Data Management Practice (GCDMP), On Site Management, Patient Recruitment, Protocol Compliance, Site Management

Preferred Skills:

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
10/22/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.