Senior Clinical Research Coordinator

SENIOR CLINICAL RESEARCH COORDINATOR JOB DESCRIPTION

SUMMARY

The primary responsibility of the Senior Clinical Research Coordinator is to manage all logistical aspects of conducting clinical trials. The Sr. Clinical Research Coordinator is required to have an in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) set forth by federal regulations. As the primary resource for the protocols, the Sr. Clinical Research Coordinator will act as a liaison between the investigators, primary care providers, and ancillary services. In partnership with the investigator, the research coordinator will screen, enroll and follow study subjects, ensuring protocol compliance. In addition, the research coordinator is responsible for data collection, source documentation and adverse experience reporting. The research coordinator serves as a liaison between the Sponsor/CRO and the site for patient related activities associated with a specific protocol and onsite trial activities.

SUPERVISORY RESPONSIBILITIES

· As a Sr. CRC, provide guidance, training, and direction to other study team members.

CORE CRC RESPONSIBILITIES

· Coordinate site qualification and study startup visits.

· Coordinate interim monitoring visits and study close-out visits.

· Organize and conduct training for research staff on protocols and research procedures.

· Creates meeting agendas and coordinates meetings with staff, sponsor, and vendors.

· Works with clinical trial finance office to ensure accurate clinical trial billing and study receivables for completed procedures or visits.

· Monitors study activities to ensure compliance with protocols and with relevant local, federal, state regulatory, and institutional polices. Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms.

· Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Oversees subject enrollment to ensure that informed consent is properly obtained and documented.

· Ensures compliance with the treatment protocol parameters and schedule of events, conducting and documenting the informed consent, collection and reporting of adverse events, drug dispensation (oral agents only), calculating and documenting accountability.

· Timely biospecimen processing per protocol, timely data abstraction and entry into the EDC.

· Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.

· Performs ICF & HIPAA form creation & protocol submission to the IRB in a timely fashion and with minimal return stipulations.

· Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.

· Collaborates with the pharmacy and chemo nursing staff on protocols requiring IV medications and ensures proper drug supply, receipt, administration, and accountability of IV investigational products.

· Orders drugs or devices necessary for study completion.

· Able to obtain vitals, administer 12 Lead ECG’s, draw blood, process tissue and blood specimens, and ship research specimens in accordance with GLP & IATA standards.

· Maintains excellent rapport with PI, Sub-I, Nursing Staff, and patients

· Can work autonomously (self-direct) as well as collaborate with research and clinic staff

· Works with human specimens in a lab with equipment such as pipettes, test tubes, centrifuges, refrigerators, -20 C freezer, -80 C freezer, dry ice, and liquid nitrogen.

REQUIRED SKILLS:

· Working knowledge of medical and clinical research terminology.

· In-depth knowledge of ICH, GCP, FDA, IATA, GLP best practices & regulations.

· Understanding of the principles of leadership, administration, and management.

· Ability to coordinate multiple therapeutic phase I-IV drug or device trials.

- Oncology Experience not required but would be preferred.

· Demonstrates excellent verbal and written communication skills.

· Effective time management and analytical skills

EDUCATION AND EXPERIENCE:

· Clinical Experience across many therapeutic areas including oncology, preferred.

· Allied Heath Certification & 5 years of experience as a CRC or equivalent position coordinating therapeutic II-IV drug or device trials.

· BA/BS & 3 years of experience as CRC or equivalent position coordinating therapeutic II-IV drug or device trials.

Benefits:

• Compensation: Competitive base salary

• Excellent Benefits: Medical, dental, vision and 401 K

• Culture: High-performance Concierge Culture

• Gym Membership, Access to Biohacking & Regenerative Medicine

If this sounds like a good fit, and you are excited to do something challenging and meaningful that preserves your ability to enjoy life to the fullest, then please apply ASAP. We cannot wait to meet you!