12/5/22, 11:28 AM Clinical Research Associate (CRA) job in Guaynabo, Guaynabo, Puerto Rico | Clinical jobs at Merck

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Clinical Research Associate (CRA) Saved Jobs

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Job Requirements

This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipelin

Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.

The Clinical Research Associate role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the Clinical Research Associate manager, the person ensures compliance of study conduct with ICH/GCP and country regulation

company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Actively develops and expands the territory for clinical research, nding and developing new sites.

Participates in internal meetings and workstreams for monitoring processes and systems.

Responsibilities include, but are not limited to:

Performs clinical study site management/monitoring activities;

Participates & provides inputs on site selection and validation activities.

Performs remote and on-site monitoring & oversight activities.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and

& non-visit contact reports appropriately in a timely manner.

Conveys with Investigators and site sta on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation,

audits/inspections and overall site performance.

Works in partnership with GCTO country operations, nance, regulatory a airs, pharmacovigilance, legal and regional operations;

Contributes to Clinical Research Associate team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and disclosing best pract
appropriate.

Promotes and/or guides audit/inspection activities as needed.

Work Experience

Main requirements:

B h l ' d i i d/ bi l
https://jobs.merck.com/us/en/job/MERCUSP-100593en_US/Clinical-Research-Associate-CRA 1/6
12/5/22, 11:28 AM Clinical Research Associate (CRA) job in Guaynabo, Guaynabo, Puerto Rico | Clinical jobs at Merck
Bachelor's degree in science and/or biology.
Applicant sign-in (https://msd.wd5.myworkdayjobs.com/SearchJobs/login) Saved jobs (https://jobs.merck.com/us/en/jobcart)
Mininum 2 years of direct site monitoring experience in a bio/pharma/medical industry.

Fluent in Spanish and English (verbal and written) and excellent communication skills, including the ability to understand and present technical informa
e ectively. (https://www.merck.com/index.html)

Clinical Research Associate (CRA)

Good comprehension and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research
Saved Jobs law & guidelines.
Good comprehension of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

Hands on knowledge of Good Documentation Practices.

Demonstrated high level of monitoring skill with independent professional judgment.
Proven Skills in Site Management, including management of site performance and patient recruitment.

IT skills (Use of Microso O ce, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT application
devices.

Ability to understand and evaluate data/metrics and act appropriately.

Capable of managing complex issues, works in a solution-oriented manner

Availability to travel domestically approximately 65%-75% of working time. Expected travelling ~2-3 days/week. Current driver’s license.

Main So Skills Expectations:

E ective time management, organizational and interactive skills, con ict management, problem solving skills.

Able to work highly objectively 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 with high quality and compliance mind-set.

Requisition ID:P-100593

Email this job to:

Recipient’s Name Recipient’s Email address S

Meet Jesus - a Colombian in New York City | Merc…

Merc…

https://jobs.merck.com/us/en/job/MERCUSP-100593en_US/Clinical-Research-Associate-CRA 2/6
 FABIOLA A. ALVARADO
RODRIGUEZ

CONTACT Mr. Anton G. Roure Moulier

Human Resources
Director of ?
(787)-673-1978 15
fabiola.alvarado4@upr.edu
Dear Mr. Roure:
Urb. Valle Costero
3526 calle Caracol
Santa Isabel,
I was recently searching for clinical research experience when I saw
P.R.00757 this job offer at Merck. Evenofthough I havdn tfinished my B.S. degree I
would be a great member your research team.

Your job advertisement mentions that you seek a person with soft
skills like time management
and organization which I definitely have.
to b directive member. of a student association, have to be organveed
to complete all my tasks in academics s and extracurriculars.
Even
though I haven't been
able to have research experience I had
already took courses like microbiology and genetics in where I was
able to have laboratory experience.
In the
enclosed resume you could review with more details all my
skills. I hope we could meet in
person, please contact me ifany doubt.
Sincerely,

Fabiola A. Alvarado Rodriguez

Enclosure
 FABIOLA A. ALVARADO
RODRIGUEZ

Mr. Anton G . Roure Moulier

CONTACT
Human Resources Director of
(787)-673-1978 Merck

fabiola.alvarado4@upr.edu
Dear Mr. Roure:
Urb. Valle Costero
3526 calle Caracol I was recently searching for clinical research experience when I saw
Santa Isabel, this job offer at Merck. Even though I have not finished my B.S. degree
P.R.00757 I would be a great member of your research team.

Your job advertisement mentions that you seek a person with soft
skills like time management and organization which I definitely have.
As a directive member of a student association, I have to be organized
to be able to complete all my tasks. I had already took courses like
microbiology and genetics in where I was able to have laboratory
experience.

In the enclosed resume you could review with more details all my
skills. I hope we could meet in person, please contact me if any doubt.
I would love to meet you in person and discuss my skills with you.

Sincerely,

Fabiola A. Alvarado Rodriguez

enclousure: resume
 FABIOLA A. ALVARADO
RODRIGUEZ

OBJECTIVE To
cONTACT To provide my knondedge to the reearch 7n gaji
anagement and development.
(6 (787)-673-1978
D fabiola.alvarado4 upr. edu EDUCATION byih
UERTo BIe
UNIVERSIDAD Dp 1CO AT
Urb. Valle Costero
3526 calle Caracol PONCE (UPRP)
Santa Isabel, P.R. 2020- present
00757 B.S. Biomedicine

Expected graduation date: June 2025

ACADEMIC EXPERIENCE

Bl, madi Summer Program: Fundación Dr.

Garcia Rinaldi

Program for students interested in

medicine.

PROFESsIONAL SKILLS

iaos
Highly organized
iioslo ski
Microsoft word and power point
STUDENT. AFFILIATIONS

Asociación Universitarios pro- sordos UPRP

(vocal)
2021- present
Sp4l Āmerican Medical Students Association UPRP
2020-2021

Ju oeHe joht
lodveeyo Gine