Clinical Research Coordinator

Pinnacle Clinical Research; Edinburg (TX); On-site; USD 48,000 - 66,000; Full time

Benefits offered by this job

401k

Medical, dental, vision, long-term/短期

3 weeks of paid time off

14 paid company holidays

Scrub uniform voucher

Job summary

Summit Pinnacle Clinical Research Solutions in Edinburg, TX is seeking a Clinical Research Coordinator to manage day-to-day trial operations, recruit and screen participants, and ensure regulatory compliance with FDA, ICH-GCP, HIPAA.

You will collaborate with sponsors, site staff, and vendors, maintain study documentation, track enrollment, and report participant status. Ideal candidates have 1–2 years of clinical research experience, strong communication, and attention to detail.

Qualifications

• High school diploma or GED required.
• Bachelor’s Degree in a scientific area preferred or equivalent.
• 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 CRIO/CTMS.
• Must have strong knowledge of ICH/GCP guidelines.
• Must complete GCP training before interacting with participants and recertify every 2 years or as applicable.
• Trained in Fibroscan and memory screens as required by the study portfolio.
• BLS training provided during onboarding.
• Strong organizational skills and time management with ability to track multiple projects.
• Strong written and oral communication skills.
• Knowledge of basic medical terminology.
• Proficient in Spanish and English preferred.

Responsibilities

• Clinical Trial Execution: Exercise judgement within trial protocols and SOPs.
• Maintain participant privacy and data confidentiality per sponsor regulations (FDA, ICH GCP, HIPAA).
• Complete study-directed assessments and documentations including consent and vital signs.
• Data management and regulatory documentation per guidelines.
• Interface with sponsors and vendors; participate in monitoring visits and audits.
• Manage participant recruitment and engagement through study completion.
• Respond promptly to information requests and identify opportunities to improve participant care.
• Collaborate with team to resolve study-related challenges.
• Develop and maintain relationships to achieve research outcomes.
• Coordinate multiple projects with competing priorities as directed.
• Attend investigator meetings and site visits as appropriate.
• Track enrollment and site status to meet goals.

Skills

Strong communication

Organizational skills

Bilingual English/Spanish preferred

Data privacy and confidentiality

Problem-solving

Proactive

Education

Bachelor’s Degree in a scientific field

High school diploma or GED

GCP training completed

Tools

CRIO/CTMS

Fibroscan

Microsoft Office

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Research Coordinator

Full Time Edinburg, TX, US

2 days ago Requisition ID: 1077

Summary: The Clinical Research Coordinator 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 report on 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 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 ClinicalOperations 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 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, andcollecting 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.

Education / Experience:

• 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
• 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 the 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
• Proficient in Spanish and English preferred

Supervisory Responsibilities: None

Certificates and Licenses: Valid Driver’s License

Knowledge, Skills, and Other Abilities:

• 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

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 is 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.
• 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.

Benefits of working at Summit Pinnacle Clinical Research:

• 401k
• Medical, dental, vision, long-term disability, short-term disability, FSA, and life insurance
• 3 weeks of paid time off
• 14 paid company holidays
• Scrub uniform voucher (specific positions apply)
• And more!

Summit Clinical Research Solutions 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.