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Form of workCome join our team and make a difference as we blaze the way into the future of liver medicine. Pinnacle Clinical Research is dedicated to conducting cutting-edge research with a special focus on fatty liver disease (non-alcoholic). We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Be a part of the discovery!
Summary: Pinnacle Clinical Research seeks a Clinical Research Assistant, responsible for assisting with the day-to-day operations of clinical trials alongside the Clinical Research Coordinator and Investigators, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and pre-screen study participants. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information.
The Clinical Research Assistant must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the PCR team, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, and a team-player. This role reports directly to the Clinical Research Project Manager.
Duties and Responsibilities:
Clinical Trial Execution:
- Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the Clinical Research Coordinators (CRC), study investigator, Project Manager, and Director of Clinical Research Operations
- 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 not limited to, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.
- Assist and complete study related documents and new study preparation.
- Function as a secondary liaison with pharmaceutical sponsors and external vendors
- Respond to internal and external requests for information in a timely manner.
- Perform subject pre-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.
- Perform laboratory and/or pharmacy duties as outlined in the protocols and/or manuals as directed.
- Assists with the preparation for study monitor visits and/or audits as directed.
- Interacts with internal and external personnel to include, but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.
Administration:
- Complete electronic case report forms
- Create and maintain reports and/or spreadsheets as requested.
- Enter all patient data into the clinical trial management system in a timely manner.
- Assist with maintaining study documents and electronic regulatory documents.
- Organize and file study documents in regulatory binders.
- Request medical records and maintain the applicable spreadsheet(s)
- Assist with organizing study inventory (IP, Lab Kits, etc.)
- Assist with data entry in study assigned portals as applicable.
- Assists with coordinating multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume.
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.
Qualifications:
- High school diploma or general education degree (GED) required.
- Associate or bachelor’s Degree in scientific area of study or equivalent combination of education, training, and experience preferred.
- Proficient in all Microsoft Office applications
- Proficient in Clinical Research IO (CRIO) or equivalent CTMS preferred, but training will be provided during onboarding.
- Must have strong knowledge of ICH/GCP guidelines.
- Must complete CITI and GCP training before interacting with participants and must re-certify every 3 years.
- Must be trained and certified in administration of Fibroscan, training provided during onboarding.
- 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
- 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.
- Proficient in English and Spanish preferred
Competencies:
- 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 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 Environment and Physical demands:
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Work is performed in an office/laboratory and/or a clinical environment.
- Exposure to biological fluids and/or bloodborne pathogens.
- Personal protective equipment required such as protective eyewear, garments, and gloves.
- Occasional travel may be required domestic and/or international.
- Ability to work in an upright and/or stationary position for 6-10 hours per day.
- Frequent mobility required.
- Occasionally squatting, kneeling, or bending.
- Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.
Benefits of working at Pinnacle Clinical Research:
- 401k
- Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
- 3 weeks of paid time off
- Twelve paid company holidays
- Tranquility Room
- Pinnacle Gym
- Scrub voucher (specific positions apply)
- And more!
Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
