Clinical Research Coordinator I

Pinnacle Clinical Research•Dallas, TX

About The Position

Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Dallas Research Institute, 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. Be a part of the discovery! Summary: The Clinical Research Coordinator I will manage the day-to-day operations of assigned clinical trials and ensure that pre-established work scope, study protocol, and regulatory requirements are followed. They will recruit and screen study participants, document and report on the daily operations of a study, and participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities promptly. This position is responsible for a broad range of duties involving confidential information. Strong communication and organizational skills are essential, along with a proactive, problem-solving mindset. The Clinical Research Coordinator I must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high-quality participant care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, and external vendors, and, therefore, must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team player, and able to manage multiple projects effectively and efficiently. This role reports directly to the Clinical Operations Manager.

Requirements

High school diploma or general education degree (GED) required
Bachelor’s Degree in a scientific area of study preferred or equivalent combination of education, training, and experience, or promotion internally from the Research Assistant role
1 year of experience as a Clinical Research Assistant or Coordinator
1-2 years of experience in Clinical Research
Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS
Must have strong knowledge of ICH/GCP guidelines
Must complete GCP training before interacting with participants and must recertify every 2 years or as applicable
Trained and certified in the administration of Fibroscan and memory screens as required by study portfolio and individual experience. Training to be provided
Must have basic life support (BLS) training, provided during onboarding
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
Must be able to effectively communicate with all levels of internal and external contacts
Demonstrated ability to manage a high-volume workload with multiple clinical trials while maintaining accuracy and compliance.
Ability to work independently and multitask 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 research participants
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 able to work effectively in an entrepreneurial environment
Ability to work in an upright and/or stationary position for 6-10 hours per day.
Frequent mobility required.
Occasional 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.

Nice To Haves

Proficient in Spanish preferred

Responsibilities

Clinical Trial Execution: Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Operations Manager, and Site Director or Regional Director
Maintain participant privacy and data confidentiality, complying with the appropriate sponsor requirements and regulations, which include the FDA, ICH GCP, HIPAA, institutional review board determinations, and institutional policies and procedures
Complete study-directed assessments with participants, which may include, but are not limited to, informed consent, medical history, adverse events, Fibroscan, memory screen, test article handling, appointment scheduling, records review, treatment coordination, and collecting vital signs
Complete documentation and data management related tasks as instructed by supervisor and compliance leadership in accordance with GCP and other regulatory guidelines
Function as a liaison with pharmaceutical sponsors and external vendors, including but not limited to, participating in monitoring visits and audits
Responsible for participant management and engagement from the recruitment of study participants to study completion as applicable.
Respond to internal and external requests for information promptly
Identify opportunities to improve participant care and satisfaction
With a solutions-oriented and collaborative mindset, resolve study-related challenges within a reasonable time set by the supervisor
Establish, develop, and maintain productive relationships with internal and external personnel to achieve a high standard of research outcomes.
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
Track enrollment status reports to ensure study sites stay on track to meet enrollment goals
Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status is kept current
Administration: Create memos, emails, and letters related to study activities
Create and maintain reports and/or spreadsheets as requested
Assist regulatory personnel in maintaining study documents and ensure electronic regulatory documents are saved and uploaded appropriately
Responsible for reporting safety information to regulatory agencies
Perform quality checks on source documents specific to the study
Assist with the Corrective and Preventive Action Plan (CAPA) process as needed
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.