Senior Clinical Research Coordinator (51328)

Who We Are:

Platinum Dermatology Partners is a network of high-quality dermatology clinics that focus on collaborative and innovative ideas to drive growth. We offer general dermatology, cosmetic, medical, plastic surgery, and cancer screening treatments. We have over 120 clinics, over 350 providers, and more than 2100 employees in clinics across Texas, Arizona, California, Nevada, and Florida. We are a rapidly growing company that allows our doctors to focus on providing exceptional care without worrying about the operational side of the business. Our core values focus on collaboration, ownership, respect, excellence, authenticity, and integrity. Our purpose is to empower the practice of exceptional dermatology.

Company Conformance Statements:

In the performance of their respective tasks and duties, all employees are expected to conform to the following:

• Perform quality work within deadlines with or without direct supervision.
• Interact professionally with other employees, customers, and suppliers.
• Work effectively as a team contributor on all assignments.
• Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations.

Position Purpose:

Responsible for performing all administrative aspects of clinical trial research studies based upon the needs and goals of the Research Program. Tasks include, but are not limited to, recruitment, completion of database logs for pre-screens, scheduling, consents, and close-out of study per protocols. Provide support to PI/sub-I as requested. This role is in-person and based in the San Diego clinic.

Responsibilities:

• Perform all research coordinator duties required to adhere to FDA guidelines and study protocols, and facilitate the daily clinical trial activities required to conduct the study, including, but not limited to:
  • Subject recruitment, screening, and enrollment
  • Collection of laboratory specimens, informed consent, and other data from the subject.
  • Maintenance of source documents, including CRF (case report form) completion and review for accuracy
  • Participation in site monitoring visits and audits.
  • Documentation of laboratory and histological procedures. Ensure accurate labeling of slide photos.
  • Filing and maintenance of all study-related documents.
  • Documents adverse events and notifies the principal investigator and appropriate agencies.
  • Notifies Director, sponsor, and IRB of any serious adverse events.
  • Assist the physician with all procedures, including excisions, injections, laser treatments, wound care, post-op care, and dressing changes.
  • Set up the exam room for the specific procedure as indicated.
  • Provide patient education and literature. Take pre- and post-treatment pictures.
  • Clean pack and sterilize instruments. Assists in cleaning rooms.
  • Monitor the physician's schedule to maintain a timely flow.

• Ensure studies are conducted according to protocol and in accordance with GCP, ICH, and FDA guidelines. Ensure IRB guideline and SOP compliance.
• Ensure all study timelines are met, and study folders are kept updated and accurate.
• Work closely with the physician(s) and medical provider(s) assigned to the study.
• Oversee, participate, and enter data on time, perform study monitoring in peer-to-peer inter- rated methodology.
• Enter all data within 2 days of the study visit by the Research Coordinators, and query resolution is performed within 2 days of the query. Random QC monitoring process to be established bythe Director and conducted by Research Coordinators in peer-to-peer inter-rated methodology.
• Perform other tasks/duties as requested or assigned by PI/sub-I and Director.
• Must be able to travel to oversee studies in multiple sites as required.
• Coordinate study schedules with practice personnel.
• Train other team members on study protocols and visits.

Education and Experience:

• Bachelor's Degree required. Health Sciences background preferred.
• 3 years of prior experience; knowledge of phlebotomy techniques
• Knowledge of the IRB regulatory submission process, GCPs, and CFRs related to research.
• Certified Clinical Research Coordinator (CCRC) designation is a plus.

Essential Skills and Abilities:

• Committed to executing exceptional patient service and satisfaction.
• Ability to support the organization's preferences and priorities.
• Ability to generate respect and trust from colleagues and leadership.
• Excellent listening, oral, and written communication skills.
• Tactful, mature, and able to interact well with diverse personalities.
• Able to exemplify professional behavior in all aspects of the position.
• Computer-literate with good keyboarding skills

Ability to operate basic office equipment such as a phone, fax, copier, printer, etc.

Our competitive benefits package includes the following:

• Medical, Dental, and Vision insurance
• Short-term/Long-term disability
• Life and other voluntary plans
• 401(k) plan
• Employee Referral Program
• Paid Time-Off
• Company-Paid Holidays

Equipment Operated: Standard office equipment, including computers, fax machines, copiers, printers, telephones, etc.

Physical Requirements: Must possess manual dexterity to operate office machine,s including computer and calculator; stooping and bending to handle files and supplies; and mobility to complete errands or deliveries. Includes handling of sharps and chemicals.

Equal Employment Opportunity:

Platinum Dermatology Partners is committed to a policy of equal employment opportunities for applicants and Employees. Employment decisions will comply with all applicable laws prohibiting discrimination in employment, including Title VII of the Civil Rights Act of 1964, The Age Discrimination in Employment Act of 1967, the Americans with Disabilities Act of 1990, the Immigration and Nationality Act, the California Fair Employment and Housing Act, and all other applicable state and federal laws.

Platinum Dermatology Partners does not permit discrimination of any type against an employee because of any of the following legally protected characteristics: gender, race, color, religion, country of origin, mental disability, physical disability, marital status, gender identity, gender expression, ancestry, genetic information, medical condition, age, sexual orientation, or pregnancy.

Please note, that any offer of employment is contingent on the successful completion of pre-employment background checks.

No phone calls or agencies, please.