Senior Clinical Research Associate Job

Date: Jun 12, 2019

Location: Bogotá, CO

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Requisition ID: CLI008697

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


As a Senior CRA you will:

Act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gain an in-depth understanding of the study protocol and related procedures.
Coordinate & manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
Participate & provide inputs on site selection and validation activities.
Perform remote and on-site monitoring & oversight activities using various tools to ensure:

  • Data generated at site are complete, accurate and unbiased

  • Subjects’ right, safety and well-being are protected

Conduct 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.
Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study closeout.
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, assess and resolve site performance, quality or compliance problems and escalates per defined CRA Escalation
Pathway as appropriate in collaboration with CRM, PLM and RCPM.
Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
Contribute strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices,
making recommendations for continuous improvement and providing training as appropriate/required.
Support and/or lead audit/inspection activities as needed.
Mentor or buddy junior CRAs on process/study requirements and performs co-monitoring visits where appropriate

Position open to several locations including: Bogotá, Medellín, Cali

Qualifications

Education


B.A./B.S. in health areas preferred with strong emphasis in science and/or biology
Fluent in Local language and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.


Experience & Skills


Min. 4 years of direct site management (monitoring) experience in a bio/pharma./CRO.
Ability to travel domestically and internationally approximately 65%-75% of working time.
Expected travelling ~2-3 days/week.
Current driver’s license preferred.
Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Demonstrated ability to mentor/lead
Hands on knowledge of Good Documentation Practices
Proven Skills in Site Management including independent management of site performance and patient recruitment
Demonstrated high level of monitoring skill with independent professional judgment.
Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
Ability to understand and analzse data/metrics and act appropriately
Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
Able to work highly independently across multiple protocols, sites and therapy areas
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships
Works with high quality and compliance mindset
Demonstrates commitment to Customer focus
Local regulation Knowledge
GCP training

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.



Job: Clinical Research Monitor
Other Locations: Medellín, Ant, CO; Cali, Vac, CO
Employee Status: Regular
Travel: Yes, 75 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Research Associate, Clinic, Clinical Research, Medical Research, Research, Healthcare

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