Associate Clinical Research Associate

hace 4 semanas

San Blas, España MSD A tiempo completo

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are looking for an Associate Clinical Research Associate (Associate CRA) to join our team. With support of SrCRA/CRA and/or CRA Manager, this person will act as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

Responsibilities:

Develops strong site relationships and ensures continuity of site relationships through all

phases of the trial.

Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

Gains an in-depth understanding of the study protocol and related procedures.

Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

Participates & provides inputs on site selection and validation activities.

Performs remote and on-site monitoring & oversight activities using various tools to ensure:

o Data generated at site are complete, accurate and unbiased

o Subjects’ right, safety and well-being are protected.

Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

Communicates with Investigators and site staff on issues related to protocol conduct,

recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

Identifies, assesses and resolves site performance, quality or compliance problems and

escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA

Manager, CRM, TA Head and CRD as needed.

Works in partnership with GCTO country operations, finance, regulatory affairs,

pharmacovigilance, legal and regional operations, HQ functional areas and externally with

vendors and IRB/IECs and Regulatory Authorities in support of assigned sites

Manages and maintains information and documentation in CTMS, eTMF and various other

systems as appropriate and per timelines.

Supports audit/inspection activities as needed.

Performs co-monitoring where appropriate.

Requirements:

Bachelor’s degree in science

Minimum 2 years of clinical research experience

Fluency in English (verbal and written) and excellent communication skills.

Ability to travel domestically.

Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

Hands on knowledge of Good Documentation Practices

Developing skills in Site Management including management of site performance and patient recruitment

Developing level of monitoring skill and independent professional judgement

Good IT skills

Works with high quality and compliance mindset

Capable of managing complex issues, solution -oriented approach

Ability to perform root cause analysis and implement preventative and corrective action.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:06/7/2024

*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.

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