Clinical Research Coordinator

Duties and Responsibilities

• 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 other members of the team, pharmaceutical sponsors, and external vendors, including but not limited to, participating in monitoring visits and audits
• Coordinate multiple projects with competing priorities and deadlines as needed, based on clinical trial protocol directives and study volume
• Attend 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
• Create memos, emails, and letters related to study activities
• Aid in the creation and maintenance of 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 execute the Corrective and Preventive Action Plan (CAPA) process as needed

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
• Strong knowledge of ICH/GCP guidelines
• Must have completed 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
• 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

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
• Able to work independently and collaborate with a team
• 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!

Equal Opportunity Employer

Summit 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.