Clinical Research Coordinator - Pinnacle Clinical Research

• Exercise judgment within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator and site director.
• Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures.
• Complete study-directed assessments with patients which include, but are not limited to, informed consent, subject history, adverse events, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.
• Create and complete study-related documents and new study preparation.
• Function as a liaison with pharmaceutical sponsors and external vendors.
• Prepare for study monitor visits (onsite or remote), audit inspections, etc.
• Respond to internal and external requests for information in a timely manner.
• Perform subject screening and recruitment.
• Contribute to data management for research projects.
• Identify opportunities to improve patient care and satisfaction.
• Conduct patient-facing encounters with compassion, empathy, and thoroughness.
• Must be able to review medical records against Inclusion/exclusion criteria to identify potential subjects.
• Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose.
• Obtains and documents adverse event data on appropriate forms.
• Ensure source documents are transcribed to the EDC platform per protocol in a timely manner.
• Ensure EDC queries are answered within the required time set by the Project Manager or Data Management team.
• Resolve other study-related queries within a reasonable time set by the Project Manager or Data Management team.
• Interact with internal and external personnel such as physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients.
• Coordinate multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume
• Attends the investigator’s meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by Monitors or Sponsor representatives as appropriate.

• Ensure that electronic case report forms are completed.
• Create memos, emails, and letters related to study activities.
• Create and maintain reports and/or spreadsheets as requested.
• Ensure that all patient data is entered into the clinical trial management system in a timely manner.
• Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections.
• Responsible for reporting safety information to all regulatory agencies.
• Understand the aspects of Regulatory and IRB requirements for studies.
• Performs quality checks on source documents specific to the study.
• Assist with the Corrective Action Preventive Action Plan (CAPA) process as needed.

• *    Experience with pharma-sponsored trials
• Highschool diploma or general education degree (GED) required.
• Bachelor's degree in a healthcare or science-related field or Psychology, Social Work, Pharmacy, Nursing, or Certified Medical Assistant.
• Minimum of 4 years of experience working in clinical research operations with industry manufacturers and sponsors.
• Experience in geriatric/neuro a plus.
• Experience working with an aging population.
• Thorough knowledge of clinical trial operations, regulatory guidelines.
• Ability to manage time-sensitive activities in a dynamic environment while maintaining attention to detail.
• Excellent documentation, computer, and interpersonal skills.
• Knowledge of EDC systems such as RAVE, Redcap, Inform.
• GCP trained, IATA certification preferred.
• Proficient in all Microsoft Office applications.
• Must have strong knowledge of ICH/GCP guidelines.
• Must complete CITI training before interacting with participants and must re-certify every 3 years.
• Must have basic life support (BLS) training, provided during onboarding.
• Valid driver's license with maintenance of safe driving record and an automobile that is insured in accordance with the state.
• Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time
• Strong written and oral communication skills in a clinical research environment.
• Knowledge of basic medical terminology.
• Possess impeccable integrity and personal and professional values that are consistent with PCR’s high standards and mission.
• Comply with the company policies, code of ethics, and guiding values always.

• Must be able to effectively communicate with all levels of internal and external contacts.
• Ability to work independently and multi-task in a fast-paced team environment.
• Strong people skills including the ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment.
• Must possess a positive, friendly, and professional demeanor, particularly when interacting with patients.
• Must be able to work independently and collaborate with a team.
• Ability to interpret clinical research protocols.
• Strong problem-solving and decision-making skills, particularly when under pressure.
• Proactive at identifying, addressing, and solving issues in real-time.
• Energetic self-starter, results-oriented, and the ability to work effectively in an entrepreneurial environment.

• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens. 
• Personal protective equipment is required such as protective eyewear, garments, and gloves.
• Travel between two NJ sites is required.
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility is required.
• Occasionally squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moving) objects including medical equipment with a maximum lift of 20-50 lbs.

• 401k
• Medical, dental, vision, long-term disability, short-term disability, HSA, and life insurance
• 3 weeks of paid time off
• 12 paid company holidays
• Tranquility Room (specific locations only)
• Pinnacle Gym (specific locations only)
• Scrub voucher (specific positions apply)
• And more!

At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare.