Senior Clinical Research Associate - Cns

Job Description

Job Description

Senior Clinical Research Associate

C-Clinical is looking for an experienced Senior Clinical Research Associate to oversee clinical studies in the San Diego area. This opportunity combines remote monitoring with on-site visits, offering flexibility while maintaining direct involvement in study oversight and quality.

We are looking for professionals with a background in CNS, oncology, or metabolic indications who understand regulatory requirements, protocol adherence, and effective site communication. Strong organizational skills, attention to detail, and a proactive approach to resolving study challenges are important for success.

At C-Clinical, collaboration, integrity, and meaningful research guide our work. You will contribute your experience within an environment that values professional relationships, shared responsibility, and the advancement of clinical research.

If you are an experienced CRA based in the San Diego region and want to contribute to a purpose-driven organization, we would like to connect with you.

Interested? Apply now.

$65 - $95 hourly

Sr. CRA – San Diego Area (On-site/Hybrid)

• Interfaces with the study team to ensure timely initiation and completion of clinical trials

• Responsible for the identification, evaluation, and qualification of investigators and sites in the San Diego area and surrounding region

• May prepare and submit essential document packages required for clinical site initiation

• Performs on-site monitoring activities for clinical trials and escalates site issues to the Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in monitoring reports and follow-up correspondence

• Reviews and manages data on-site and remotely; resolves issues on a continuous basis to achieve timely database targets

• May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidance

• Ensures the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements

• Identifies, tracks, and follows up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensures all applicable SAEs are reported to sponsor and regulatory authorities

• Ensures the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, through comprehensive source document review. Monitors study databases for missing or discrepant data compared to source records

• Ensures that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project-specific plans (e.g., monitoring plan)

• Maintains study blinding and serves as a blinded study monitor as needed; conducts eCRF/CRF review, query generation, and resolution based on established data review guidelines, with or without direct supervision

• Attends investigator meetings, project team meetings, and teleconferences as needed

• Understands and applies knowledge regarding local, state, and federal regulations (e.g., FDA, ICH-GCP)

• Maintains current training on ICH-GCP, study protocols, and internal procedures

• May track regulatory documentation, monitor site recruitment, assess study site quality and compliance, and help motivate assigned sites to meet study timelines and goals

• 3 years or more as a CRA with site monitoring responsibility  and 1 year or more in CNS

Or

• 3 years or more as a CRA with site monitoring responsibility  and 1 year or more in either: Phase 1, a complex indication with inpatient monitoring,  or metabolic studies

Or

• 3 years or more as a CRA with site monitoring responsibility  and 1 year or more in Oncology Monitoring 

And

• The candidate possesses a 4-year university degree, ideally in a scientific field

• In lieu of a 4-year university degree, a candidate with 7 or more years of relevant clinical research experience, nursing/possibly another medical certification, and 5 years of monitoring in a complex indication (inpatient, oncology, phase 1, etc.) may be considered

• Must have work authorization in the United States

• Must be located within the greater San Diego area

• The candidate must have availability for at least 1 year

• Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminology

• Bilingual is a plus

• Corp to Corp

• Must be proficient at tactfully managing intra-team communication, as well as interpersonal communication

• Note: the travel rate is 50% of the regular rate

C-Clinical in San Diego drives clinical operations excellence across the pharmaceutical, biotechnology, and device sectors.

Our chief concept is guiding relationships and directing the government. We go by "love" as a principle: love your neighbor as yourself, and charity.

C-Clinical was not an act of compulsion, but the care one would have for family.

Bottom line: we created this company to do what we love to do: life-changing medical research, and to dedicate our time, talents, and resources to those who need them.