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Remote Clinical Research Protocol Writer Jobs in Virginia

AbbVie

Clinical Research Associate II

Richmond, VA · On-site +1

$78K/yr

Advanced level of competency connecting the study protocol, scientific principles and clinical ... Strong interpersonal skills with excellent written, verbal, active listening and presentation ...

IQVIA

Clinical Trial Psych Rater

Fairfax, VA · Remote

$62K - $156K/yr

Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services ...

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Remote Clinical Research Protocol Writer information

What does a remote clinical research protocol writer do?

A Remote Clinical Research Protocol Writer is responsible for creating detailed documents that outline the objectives, design, methodology, and organization of clinical research studies. They collaborate with clinical teams, researchers, and regulatory experts to ensure that protocols comply with regulatory standards and support the scientific goals of the study. Working remotely, they use digital tools to gather data, review literature, and communicate with stakeholders. Their work is essential for guiding clinical trials, ensuring participant safety, and supporting regulatory submissions.

What are the key skills and qualifications needed to thrive as a remote clinical research protocol writer?

To excel as a Remote Clinical Research Protocol Writer, you need a background in life sciences or healthcare, strong scientific writing skills, and familiarity with regulatory guidelines such as GCP and ICH. Proficiency in tools like Microsoft Office, reference management software, and electronic data capture (EDC) systems is commonly required. Exceptional attention to detail, time management, and the ability to collaborate virtually with multidisciplinary teams are vital soft skills. These competencies ensure the creation of accurate, compliant, and clear research protocols that support successful clinical trials and regulatory submissions.

How does a remote clinical research protocol writer typically collaborate with research teams and stakeholders?

As a Remote Clinical Research Protocol Writer, you will frequently collaborate with cross-functional teams such as clinical trial managers, biostatisticians, regulatory affairs specialists, and medical experts. Communication often occurs through virtual meetings, emails, and shared document platforms to ensure all protocol elements meet regulatory, ethical, and scientific standards. You may be responsible for gathering input, incorporating feedback, and ensuring that protocols are clear and aligned with study objectives. This collaborative process is essential for creating robust documents that support successful study execution and regulatory submissions.

What is the difference between Remote Clinical Research Protocol Writer vs Remote Clinical Research Associate?

AspectRemote Clinical Research Protocol WriterRemote Clinical Research Associate
CredentialsTypically requires a degree in life sciences, clinical research certification preferredRequires a degree in life sciences or related field, often with GCP or ICH certifications
Work EnvironmentPrimarily writing and editing protocols remotely, collaborating with teamsMonitoring clinical sites remotely, ensuring protocol compliance
Industry UsageUsed mainly in pharmaceutical and biotech companies for protocol developmentUsed across clinical trial sites for monitoring and data collection

The Remote Clinical Research Protocol Writer focuses on creating and editing clinical trial protocols, while the Remote Clinical Research Associate is responsible for monitoring trial sites and ensuring compliance. Both roles require knowledge of clinical research processes and often share similar certifications, but their daily tasks and work environments differ significantly.

What are the most commonly searched types of Clinical Research Protocol Writer jobs in Virginia?

The most popular types of Clinical Research Protocol Writer jobs in Virginia are:

What are popular job titles related to Remote Clinical Research Protocol Writer jobs in Virginia?

For Remote Clinical Research Protocol Writer jobs in Virginia, the most frequently searched job titles are:

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The top searched job categories for Remote Clinical Research Protocol Writer jobs in Virginia are:

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Remote Clinical Research Protocol Writer jobs near you

Clinical Research Associate II

AbbVie

Richmond, VA • On-site, Remote

$78K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 16 days ago

AbbVie rating

8.7

Company rating: 8.7 out of 10

Based on 102 frontline employees who took The Breakroom Quiz

14th of 86 rated pharmaceutical

Job description

Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
Responsibilities
  • Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie's positioning.
  • Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
  • Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
  • Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
  • Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
    Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
  • Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
    May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
  • Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
  • Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
  • Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
  • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
    Ensures audit and regulatory inspection readiness at assigned clinical site at all times.
    Manages investigator payments as per executed contract obligations, as applicable.

Qualifications
  • Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
  • Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk-based monitoring approach, onsite and offsite monitoring.
  • Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
  • Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
  • Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
  • Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
  • Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
  • Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
  • Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
  • Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html

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About AbbVie

Sourced by ZipRecruiter

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

Industry

Scientific research and development services

Company size

10,000+ Employees

Headquarters location

North Chicago, IL, US

Year founded

2013

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