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Summary: The Clinical Research Coordinator II 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 II 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.

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, 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.
Serve as mentor/trainer for less experienced staff to assist with general and study-specific issues.

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, or promotion internally from the Clinical Research Coordinator I role.
2-3 years of experience as a Clinical Research Coordinator.
3-4 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.
Proficient in Spanish and English required.

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 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 in 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 Clinical Research Solutions:

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.

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