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Clinical Research Associate II


Groton, CT
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Job Details

The Clinical Research Associate II is responsible for the identification, evaluation, selection, initiation, monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards.

The Clinical Research Associate II r ole is accountable for clinical trial monitoring and managing investigator site relationships to ensure effective delivery of clinical trials (e.g. site activation, enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site health), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders.

The Clinical Research Associate II is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with study team members as required in activities associated with the set-up, running and close out of a clinical trial.


**Responsible for investigator site management and monitoring for assigned sites:**

**Clinical Trial Monitoring**

+ Provide input into and/or develop study related materials such as protocols, Clinical Monitoring Plans, Data Management Plans, eCRF forms, data completions guidelines, patient diaries, recruitment plans, protocols and patient informed consents

+ Ensure proper conduct of clinical trials in accordance with the Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards to achieve project goals, timelines and quality

+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from study start-up through database lock, ensuring relevant timelines and quality deliverables are met

+ Identify, evaluate and select investigator sites as needed

+ Serve as the primary point of contact for assigned investigator sites

+ Manage external vendors as needed

+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites

+ Perform site qualification/Pre-Trial Assessment Visits and ensure selected sites have appropriate capabilities and access to patient populations to meet protocol and timeline requirements

+ In collaboration with the Clinical Research Site Assistant conduct or oversee investigator site activation activities, including Investigator Initiation Package (IIP) completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation

+ In collaboration with Clinical Research Site Assistant and Outsourcing Lead, oversee site payments per contracts and work with the appropriate groups to resolve issues

+ Perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks

+ Attend investigator meeting when required and develop/conduct investigator meeting presentations and/or trainings as required

+ Develop and manage investigator newsletters as needed

+ Conduct site initiation visits in collaboration with study team members as needed

+ In collaboration with appropriate study team members, develop and implement effective site recruitment plans that are consistent with the global plan and local requirements

+ Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with study team to define and support recruitment initiatives at site level

+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure visits and ensure these are conducted accordance to Monitoring Plan, SOPs and commensurate with emerging issues and technologies.

+ Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

+ Perform centralized/risk-based monitoring as required

+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File documentation, monitoring visit reports, site visit follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics

+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues

+ Provide support to investigator sites and study teams in preparation for and providing responses to site audits/inspections

+ Support study team as needed with Regulatory, Central, and Local Ethics Submissions and responses.

+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out visit within required timelines

+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities.

+ Support database release as needed

**Clinical/Scientific and Site Monitoring Risk:**

+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team

+ Interact with investigator site heath care professionals in a manner which enhances Pfizer's credibility, scientific leadership and in order to facilitate Pfizer's clinical development goals

+ Collaborate with local regulatory and study team on follow-up and documents revisions needed for optimal regulatory approval

+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators

+ May Support the study team in following up with investigators regarding the ongoing evaluation of subjects

+ In partnership with appropriate study team members contribute to the study level risk plan; mitigate for known/anticipated risks proactively

+ Monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals, etc.) and take appropriate targeted action

+ Apply knowledge of data and analytics to target site level actions for mitigation and control

+ Proactively identify, manage and escalate site issues

+ Create, update and manage a site risk plan as needed that is aligned with study level risk plans

+ Identify and address Significant Quality Events or other quality issues at patient and/or site level

+ In collaboration with appropriate study team members, create and implement corrective actions and preventative actions (CAPA) as needed

+ Ensure resolution of investigator site issues in order to maintain sound investigator relations

+ Communicate with investigators, study coordinators and other site staff on a regular basis to build and maintain productive relationships and support investigator engagement through medical and scientific discussion

**Clinical Research Associate I /Clinical Research Site Assistant Management:**

+ May have delegated responsibility from the Director of Clinical Site Management

+ Train and coach Clinical Research Associates I and/or Clinical Research Site Assistants as assigned

+ Oversee job function as described in the Clinical Research Associates I and/or Clinical Research Assistants job description

+ Support Director Clinical Site Management in assessing performance by conducting site performance visits with Clinical Research Associates I

+ Assist Clinical Research Site Assistant in site activation activities such as gathering IIP documentation where required to ensure timely site activation


+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

+ Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations

+ Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring

+ Experience in the development of study-related documents is beneficial

+ Preferred therapeutic experience in ( add TA as required )

+ Global clinical trial experience

+ Must be fluent in English

+ For individuals based in Canada: Bilingualism (French, English) is an asset

+ Ability to legally work in both Canada and USA is an asset.

+ Demonstrated knowledge of clinical research and development processes and ability to gain command of process details

+ Demonstrated knowledge of global and local regulatory requirements

+ Demonstrated understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc.)

+ Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)

+ Demonstrated ability to participate and support sponsor regulatory interactions/inspections

+ Demonstrated knowledge of the processes around protocol design and feasibility assessment

+ Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery

+ Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial

+ Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation

+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

+ **Significant travel (60-80%)** within area is required. May require some international travel and some weekend travel

+ Valid driver's license

Additional Details:

+ Eligible for Employee Referral Bonus

+ Can be remote based

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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