Clinical Research Associate 1 - PHARMA - TX/OK/KS/MO at Pharmaceutical Research Associates, Inc. in Raleigh, Texas

Job Description:

Pharmaceutical Research Associates, Inc.

Clinical Research Associate 1 - PHARMA - TX/OK/KS/MO

US-TXUS-OKUS-KSUS-MSUS-Remote


Job ID: 2021-73989
Type: US-Midwest
# of Openings: 1
Category: Clinical Monitoring

GSK

Overview

Do you want to watch clinical development change, or do you want to be the one to shape it?

Because we’re hoping you’re here for the latter.

Who are we?

We Are PRA.

We are 16,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

Who are you?

You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical Research Associate, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

Still here? Good. Because if this is you, we’d really like to meet you.

Responsibilities

What will you be doing?

• Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing
• Able to work within remote teams and
• Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
• Good interpersonal
• Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic
• Respects confidentiality in terms of
• Proactive, conscientious and precise in delivery of quality work even when under pressure
• Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely
• Flexible with high learning and change agility
• Collaborative, building strong internal and external
• Knowledge of local regulations, IND/ICH GCP - guidelines,
• Available and willing to travel as job requires
• Strong computer skills with good eye for
• Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team
• Engage and maintain good written and verbal communication with external stakeholders in order to ensure effective study
• Accountable for local activities required in set up and for high quality execution of studies; will seek managerial or other experienced support as appropriate:
• Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out
• Performs site evaluation visits:
• Determines the feasibility of the study protocol with reference to study complexity
• Confirms staff availability, suitable clinical facilities, potential for per protocol patient population,
• Confirms ability to comply with ICH GCP and requirements for clinical studies.
• Works with Study staff to carry out a local study / site level risk
• Delivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical
• Participate in global investigators and/or monitor meetings as appropriate. Facilitates investigator’s participation in global meetings and/or may assist the study staff with organizing local investigator Participates in other study meetings as required.
• Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are
• Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP).
• Work with the sites to ensure they address data queries in a timely Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time.
• Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.
• Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to safety department and other relevant departments, within the required time frames.
• Completes monitoring visit reports within the agreed
• Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS).
• Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately.
• Ensure sponsor study records are inspection ready at all times and archives records as applicable.

Qualifications

What do you need to have?

Education required:

• Undergraduate degree or its international equivalent in clinical, science, or health-related fieldfrom an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience preferred

Skills Required

• Read, write and speak fluent English; fluent in host country language required.
• 1-2 years of clinical monitoring experience required
• Knowledge of ICH and local regulatory authority regulations regarding drug
• Clinical research experience
• Knowledge of ICH and local regulatory authority regulations regarding drug
• Experience in monitoring all trial components (PSSV to COV)
• Experience in coaching/mentoring other CRAs

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

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