Kelvin Peek

Typical Duties

I: Protocol maintenance - 80%

- Prepared all protocol annual reviews, addenda, revisions, memos, safety reports, and consent form revisions for submission to the regulatory committees.

- Submitted IRB approval letters and approved consent forms to sponsors as required to ensure studies remain active.

- Supervised the distribution of protocols, addenda, memos to the Hematology/Oncology study coordinators, physicians, support staff, surgeons, pathology, radiation therapy, pharmacy, clinics, units, affiliates, and sponsor offices as needed.

- Inform study coordinators and physicians when re-consents are required.

- Assist with coordinating center functions as they relate to on-site and other site(s) participation in clinical trials and affiliate participation.

- Prepare, submit, track, and respond to all regulatory (FDA and IRB) requirements, including safety and ongoing reporting for other site(s) participating.

- Collaborated with Clinical Trial Managers to ensure clinical data from all sites (if applicable) is accurate and collected promptly by monitoring studies at each study site for conformity with study specific standard operating procedures and regulatory requirements, ensuring protocol compliance.

- Maintained regulatory records and necessary correspondence records.

- Prepared and submitted progress reports and renewals to the IRB and sponsors.

II: Affiliates - 15%

- Acted as the primary liaison and resource for local on-site and affiliate members (physicians, nurses, coordinators) regarding protocol regulatory activities.

- Trained and served as mentor/consultant for local and affiliate site study personnel regarding regulatory requirements & responsibilities.

- Identified, provided, and maintained integral regulatory documentation for all sites involved.

- Maintained tracking files for Strong Memorial Hospital and its affiliates. These files contain information regarding which studies are planned, active, or closed for each site for which have regulatory oversight.

- Monitored and requested regulatory submission requirements for all sites to ensure timeliness of submissions; alert coordinators in a timely fashion of needed information required for reports due.

III: Assisted Study Coordinators and investigators with study document management and tracking - 5%

- Provided leadership in problem solving logistical challenges to assure study objectives are achieved according to protocol and projected timeline

• Administered first aid treatment or life support care to sick or injured persons in prehospital settings.
• Communicated with dispatchers or treatment center personnel to provide information about situation, to arrange reception of victims or to receive instructions for further treatment.
• Restocked ambulance with proper equipment such as vents, ET tubes, medication and IV pump tubing to maintain optimum inventory.
• Developed and maintained rapport with coworkers and local hospital staff to facilitate efficient patient care.
• Administered tests and medication to stabilize patients in field or in transit.
• Developed and implemented performance improvement strategies and plans to promote continuous improvement.
• Conducted equipment and vehicle checks to maintain continuous and safe operation.
• Evaluated patient vital signs and status to determine care needs using pulse oximeters and electronic vital sign machines.
• Communicated with lucid patients to gather incident and medical history information.
• Trained US Armed Forces and Coalition Forces in basic life support skills, including cardiopulmonary resuscitation, oxygen therapy, wound care, patient history elicitation and splinting.