Explore Internal Opportunities

This is an entry level position.

Our ideal candidate is a professional to perform well in a team environment in the two most lucrative industries, healthcare and technology.

Responsibilities

• Update and keep records
• Research and qualify companies
• Provide troubleshooting assistance
• Stay up-to-date review project records
• Provide data to help the Business Operations
• Manage tracking tools and report on important information
• Liaise with accounts
• Be process oriented
• Competitor research
• Provide data to support your colleagues

Do your interests include?…

• Teamwork
• Working alongside high achieving colleagues
• Work that appeals to your numbers skills

Prevail InfoWorks is a great workplace for anyone, with unique advantages for those just starting out their career. We have had great success giving students and recent graduates opportunities with our company.

This job is based in our Philadelphia, PA headquarters. Job will be performed in office.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

This is an equal employment opportunity and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

Data entry Clerk is needed to meet growing company needs for increased reporting, processes, and controls, which involve entering, maintaining, and securing data. Employees will report to the company Assistant Controller on items such as:

Responsibilities

• Entering data: Accurately entering data into company systems and databases (set up new vendors, update the existing one) Enter/Update budgets.
• Maintaining data: Updating and maintaining existing data (update budgets changes, entering Invoices/payments)
• Verifying data: Checking data for accuracy and completeness (Reconcile invoices against budget and adding payment to systems)
• Organizing files: Maintaining and organizing digital and paper files
• Generating reports: Assisting with generating reports from data
• Communicating with team members: Clarifying data requirements with team members
• Ensuring data security: Ensuring data security and confidentiality
• Performing backups: Performing regular backups to ensure data preservation
• Collecting information: Collecting information from customers and clients
• Cataloging data: Tagging data for ease of reference (attaching info as required to the system)
• Retrieving data: Retrieving data as requested (reports/billing/payments)
• Identifying and correcting errors: Identifying errors in the data and taking the necessary actions to make corrections
• Following policies: Following policies and procedures
• Reporting changes: Reporting needed changes to the team

Qualifications

Education and/or Experience

• Excellent communication skills, both written and verbal
• Proficient working knowledge of Excel, and strong ability in other Microsoft products and systems
• Strong numerical and analytical skills
• Good problem-solving and time management Skills
• Highly organized and detail-oriented
• Five years of data entry experience

Work Environment

This job is performed in office setting. In Office – Philadelphia, PA a few days a week. Hybrid position between remote and in office.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

This is an equal employment opportunity and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

We are seeking a Quality Assurance Analyst to help ensure Prevail’s systems remains in in compliance with regulatory guidance which governs clinical trials. In addition, this position ensures Prevail products maintain their excellence and reliability. The position includes testing and validating software for all Prevail projects, for both internal and external customers, according to Prevail Standard Operating Procedures (SOPs). It also includes testing and validating proprietary Prevail tools used in the production of Customer projects, according to Prevail Standard Operating Procedures (SOPs).

Essential Duties and Responsibilities

• Ensuring that testing practices are in compliance with regulatory statutes including 21 CFR Part 11 and 50, ICH E6 Guideline for Good Clinical Practices and company procedural documents.
• Review and analyze system specifications, business requirements, and user stories.
• Collaborate with development teams, business analysts, and stakeholders to understand project requirements and objectives.
• Develop, document, and execute comprehensive test plans, test cases, and test scripts.
• Perform various testing types, including functional, regression, integration, performance, and usability testing.
• Identify, record, and track bugs using bug-tracking tools (e.g., Jira).
• Verify defect fixes and perform regression testing in updated builds.
• Participate in Agile/Scrum ceremonies, including sprint planning and retrospectives.
• Ensure compliance with quality standards, processes, and procedures.
• Provide regular status updates and test results to project stakeholders.
• Perform duties as directed by the Director of Quality Assurance
• Contribute to process improvement initiatives within the QA team and meet objectives as assigned

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

Bachelor’s Degree in a scientific field (or equivalent educational background), and 3-6 years of clinical research experience in a Quality Assurance role. Knowledge of FDA, ICH, HIPAA and GCP guidelines. Strong background in authoring Validation Plans and Summaries. Diverse experience with testing methodologies and manual and automated testing practices. Must be a proactive and effective communicator, with excellent interpersonal skills. Knowledge of basic computer programs such as Word, Access, Excel, Power Point, and CRM.

Language Skills

Possess the ability to communicate and comprehend written and oral instructions. Able to effectively present information and respond to questions from colleagues and customers.

Reasoning Ability

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Able to apply common sense solutions towards the execution of responsibilities.

Work Environment

This job is performed in office setting.

Other

As provided by the Americans with Disabilities Act, the company is committed to discussing and providing reasonable accommodations to its employees to help them fulfill the essential functions of their jobs.

This is an equal employment opportunity, and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

The Pharmacovigilance Analyst II will provide technical and process-related support to Prevail’s pharmacovigilance and medical monitoring activities, ensuring compliance with relevant global regulations and Standard Operating Procedures (SOPs).

Responsibilities:

• Management of safety cases and reports from all sources, including case intake/triage, data entry, quality review, medical review, and follow up activities
• Electronic documentation and filing of safety information according to SOPs and safety management processes
• MedDRA coding of data in the safety database
• Preparation of case narratives
• Reconciliation of the clinical and safety databases
• Provide support for regulatory submission preparation and review
• Coordinate safety project setup, including safety database build
• Author sponsor/project specific safety management plans
• Conduct and assess literature searches
• Participate in sponsor/investigator meetings as required
• Maintain a working knowledge of the safety database
• Maintain working knowledge of global regulatory rules and regulations, including monitoring for new or changing regulation
• Perform other duties as assigned

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

Job Qualifications

Knowledge and Experience:

• Pharmacovigilance knowledge and experience including safety case processing for clinical trials (drugs, biologics, vaccines, and medical devices). Nursing experience is a plus.
• Proficient in MS Office and Adobe Acrobat
• Good Understanding of MedDRA & WHODrug Global dictionaries
• Must display analytical and clinical skills
• Requires narrative writing skills

Education:

Degree in Nursing, Life Science, or other health-related field, or equivalent qualification/work experience

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

• Ethics – Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Customer Service – Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
• Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone’s efforts to succeed.
• Professionalism – Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.

Other

As provided by the Americans with Disabilities Act, the company is committed to discussing and providing reasonable accommodations to its employees to help them fulfill the essential functions of their jobs.

This is an equal employment opportunity, and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

The Clinical Documentation Associate is responsible for providing support to the TMF Manager and Clinical Operations personnel to ensure quality clinical trial documentation is being collected and filed for the purposes of regulatory and health authority inspections; and to ensure compliance as delegated by trial sponsors and under applicable institutional policy.

Essential Duties and Responsibilities

Department tasks

• Provides administrative and workflow support to the TMF Manager as needed to ensure rolling health of client eTMF systems.
• Coordinates ad hoc meetings on behalf of the TMF Manager and generates/circulates the associated meeting minutes where necessary.

Project tasks

• Acts as point person for receipt of documents to be submitted into the study-specific eTMF from the document originator.
• Conducts initial compliance reviews of documentation upon receipt to ensure contextual applicability of the materials.
• Submits documentation into the respective study-specific eTMFs and assigns document metadata such as document date, SOP reference, and expiration dates (as applicable).
• Maintains oversight of gaps in documentation and generates reports for fulfillment and oversight, as needed.
• Travels as necessary, consistent with project and supervisory needs.
• Other responsibilities as assigned by the TMF Manager or senior Clinical Operations personnel.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Willingness to learn a specialized skillset in a niche aspect of pharmaceutical trials.
• Excellent organizational skills and attention to detail.
• Ability to work well within a team and establish effective relationships across all levels of the organization.
• Strong computer skills (MS Office), SharePoint, and Acrobat.
• Aptitude to learn additional software programs and databases.
• Knowledge of clinical trial design, execution, and operations a plus.
• Experience utilizing Electronic Trial Master File systems and the DIA TMF reference model a big plus.

Education and/or Experience

Associate’s degree or an International Equivalent in Computer Science, Life Science, Health Sciences or Information Management or Related Field or the equivalent of relevant experience. Higher level degrees preferred but not required.

Language Skills

Possess the ability to communicate and comprehend written and oral instructions. Able to effectively present information and respond to questions from colleagues and customers.

Reasoning Ability

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Able to apply common sense solutions towards the execution of responsibilities.

The Clinical Research Associate will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. We are looking for a seasoned CRA that will be able to work with multiple indications including, CNS, specifically Alzheimer’s and Parkinson’s disease. Performs all tasks routinely and independently, seeking guidance as needed.

Essential Duties and Responsibilities

• Performs site qualification site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately escalates serious issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
• Verifies issues or risks associated with blinded or randomized information related to IP.
• Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention, and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.

Per the Clinical Monitoring/Site Management Plan (CMP/SMP):

• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study.
• Verifies site compliance with electronic data capture requirements

Additional responsibilities include:

• Site support throughout the study lifecycle from site identification through close-out
• Knowledge of local requirements for real world late phase study designs
• Chart abstraction activities and data collection
• Collaboration with Sponsor affiliates, medical science liaisons and local country staff
• Identify and communicate out of scope activities to Lead CRA/Project Manager
• Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

This is an equal employment opportunity, and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

Must demonstrate good computer skills and be able to embrace new technologies

Excellent communication, presentation, and interpersonal skills

Ability to manage required travel of up to 65% on a regular basis

Education and/or Experience

BS/BA, (MS/MA is desirable) in a health-related field

Must have strong customer service orientation and be a proactive and effective communicator. Excellent interpersonal skills are imperative.

Knowledge of basic computer programs such as Word, Excel, Power Point, MS Project, and Visio.

Work Environment

This job is a contract position.