Clinic Coordinator (Sr. Associate) - Full-time / Part-time

Org Marketing Statement

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description

* Assures clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements/guidelines

* Coordinates day to day execution of assigned protocols from recruitment through last subject, last visit

* Leads a clinic team (e.g., nurses, techs, sample processers, phone screeners, clinic screeners) to ensure subject safety, accurate interpretation of medical tests and execution of research protocols (e.g., ICD development, recruitment plans, source document creation, specimen collection activities)

Responsibilities

* Oversees the collection and documentation of electronic and/or written study data; responsible for data integrity and completeness

* Oversees subject coordination (activity sheets, bed space, follow up visits)

* Supports the recruitment of subjects for research activities conducted at the CRU; schedules and tracks potential subjects; maintains electronic and hard copy records; follows-up referral appointments/treatments as directed

* Supports informed consent activities as needed; creates, maintains and administers informational tools to assist volunteers with study comprehension and compliance

* Develops/maintains/improves technical capabilities/competencies necessary for conduct of studies in the CRU (e.g., drug administration, clinical/physiological measurements, sample collection/processing, basic nursing care, emergency care)

* Accountable for timely review and archiving of audit-ready volunteer data in accordance with SOPs and GCPs

* Actively participates in ensuring overall coordination of protocols, including study scheduling, protocol planning, and managing CRU resources (study budgets, supplies, equipment, and contract staff)

* Participates in QC of study set up in the electronic data capture system for protocols according to protocol requirements, CRU SOP's, and standardized processes, as appropriate

* Responds to and resolves queries specific to subject data collection

* Leads the clinic study teams (nursing, techs, and contract staff) within the unit in executing the assigned protocol

* Works with the regulatory lead on timelines and submissions for screening

* Works with the CRU study team (e.g., PI, PM, Director of Operations) to develop and implement recruitment strategies

* Partners with the PI to screen subjects for eligibility using protocol inclusion/exclusion criteria

* Assists in study design as it relates to feasibility, implementation, and reporting of clinical trials

* Reviews and provides input on protocols; interprets protocol detail and organizes study activities including the creation of study documents

* Develops customized recruitment strategies/tools/documents to support subject recruitment (e.g., patient trials), as appropriate

* Assists in the orientation of new CRU clinical colleagues and contractors, mentors and coaches other clinic personnel as needed

* Collects and maintains volunteer demographic and medical information

* Prospectively classifies potential study subjects in accordance with PIMS policies

* Coordinates and documents participation of individual subjects in all clinical research activities

* Creates and distributes study calendars for subject use

* Interprets protocol activities for study subjects and ensures comprehension and compliance

* Reviews/analyzes active charts (EDCMS) to find appropriate subjects to enroll in current studies

* Schedules prospective subjects for screening

* Maintains accuracy, accessibility and confidentiality of all volunteer records and reports

* Ensures that all subject records are consistently maintained in a state of inspection readiness; performs ongoing quality reviews of the data to achieve audit-readiness and to meet strict archiving timelines

* Leads or supported ICD development, informed consent session and subject orientation sessions

* Contributes to the development of screening tools

* Collects screening or study-related biologic specimens and clinical measurements (i.e., 'second floor' activities), as appropriate, to maintain competency, assure quality, and adhere to protocol requirements

* Coordinates menus, meals, vendor interaction and and any related study-specific training

* Coordinates external labs (study set up, shipments, data management) and data management/CRF/RDC execution

* Assures subject safety, including assessment of physiologic response to drug administration associated with administration of study medications by various routes (e.g., PO, IV, IM, SC, transdermal, pulmonary)

* Monitors cardiac function/status and provides emergency interventions, as appropriate

* Supports general staff training activities (e.g., telemetry, pulmonary function, EEG requirements, ACLS/BLS, ECG, vital sign)

* Supervises the initiation and monitoring of all study activities for assigned protocols

* Evaluates adverse events and intervenes as appropriate; maintains accuracy, accessibility, and confidentiality in subject records and reports

* Demonstrates professional communication and behaviors which facilitate positive attitudes and trust by the subject population toward participation in clinical research

* Available for various shifts (weekends/ evenings/ nights)

Qualifications

* Bachelor's degree in science, nursing or related discipline required

* Health care practice experience/training (e.g., nursing, paramedic), with valid license, preferred

* ACLS and BLS certification

* Understanding of local regulatory requirements (e.g., ICH, GCP)

* Understanding of the regulatory inspection process

* Understanding of the drug development process

* Bilingual an asset

* General medical-surgical nursing or related experience

* Ability to execute a variety of clinical safety measurements/assessments (e.g., ECG, vital signs, phlebotomy)

* Previous clinical research, industry, phase 1 and/or drug development experience preferred

* Proven ability to function as an effective and professional team member in diverse workgroups to accomplish business objectives.

* Working knowledge of computers, medical conditions, research techniques, and the application of clinical research

* Excellent communication skills required (written, verbal, including telephone)

* Prior marketing/recruitment experience an asset

Technical Skills Requirements:

* Superior proficiency in clinical/nursing-related skills. Provide Emergency interventions that are appropriate, immediate, and demonstrate excellent assessment skills and standard of care

* Ability to understand and manage developing issues and complexities of ongoing studies in order to ensure subject safety.

* Ability to read, comprehend, and contribute to the development of study protocols.

* Working knowledge of computers and laboratory data handling acquisition

* Comprehensive understanding of CRU study conduct in accordance with ethical, legal, and moral standards, Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs), Clinical Sciences and Clinical Research Unit management requests, and PGRD drug development goals.

* Ability to develop budget estimates, justify costs and manage performance against budget.

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.