Clinical Research Coordinator

Pinnacle Clinical Research- A Summit Solution · Farmers Branch, TX · Yesterday

On-siteAnalystFull-time

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.

Document 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.

Collaborate with 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.

Perform quality checks on source documents specific to the study.

Absorb and implement the Corrective and Preventive Action Plan (CAPA) process as needed.

Duties, Responsibilities, and Activities

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.

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.
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.

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.