Lead Research Program Coordinator - 136642

UC San Diego Health; San Diego (CA); On-site; USD 74,892 - 120,269; Full time

Job summary

A prominent healthcare organization is seeking a Lead Research Program Coordinator to manage multi-site prospective pregnancy registry studies. The role involves leading a team, ensuring protocol compliance, and requires strong organizational and communication skills. Candidates should have a Bachelor's degree and significant experience in clinical research environments. This position offers competitive compensation within a dynamic research setting.

Qualifications

• Four years of related experience or Bachelor's degree in relevant fields.
• Experience in clinical research duties and trial management.
• Knowledge of FDA policies regulating clinical trials.

Responsibilities

• Lead a team of Clinical Research Coordinators in multi-site studies.
• Recruit and follow-up with pregnant women for research.
• Manage clinical research files and ensure protocol compliance.

Skills

Clinical research experience

Excellent communication skills

Database management

Interpersonal skills

Organizational skills

Education

Bachelor's degree or equivalent

Tools

Velos

Access

Excel

MS Word

Job description

Overview

Lead Research Program Coordinator - 136642. Join to apply for the Lead Research Program Coordinator - 136642 role at UC San Diego Health.

Responsibilities

Under the general direction of the Research Program Manager, the Lead Research Program Coordinator acts as a fully operational Clinical Research Coordinator. The incumbent leads a team of Assistant Clinical Research Coordinators and assists with managing multi-site prospective pregnancy registry studies including providing all aspects of protocol management, including screening for patient eligibility, data collection, ensuring protocol compliance, adverse drug event reports and maintenance of accurate and complete clinical research files.

Responsible for recruitment and follow-up of pregnant women who have certain diseases, and/or who take certain medications and vaccines. The incumbent has knowledge of and ability to identify pregnancy exposure risks, has the ability to obtain and respond to very sensitive and personal health information over the telephone in a professional manner, as well as read and understand medical terminology. Additionally, the Research Program Coordinator will be responsible for assisting with training of the interview staff, as well as students, delegating workload as directed by the Research Program Manager, creating and updating reference materials, generating reports and performing validation/auditing of data. The position provides work direction to Assistant Clinical Research Coordinators, responds to questions and provides training. Performs other duties as assigned.

Minimum Qualifications

• Four (4) years of related experience, education/training, or Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree.
• Experience performing clinical research duties in a clinical research environment.
• Experience using database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.
• Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
• Experience working with FDA policies regulating clinical trials.
• Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
• Experience interpreting medical charts, experience in abstracting data from medical records.
• Experience with clinical trials participant or study subject recruitment.
• Experience coordinating study startup activities.
• Experience providing in-service training to various research personnel on protocols, processes, and procedures.
• Knowledge of x-rays, scans, and other diagnostic procedures.
• Experience maintaining files and keeping records.
• Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.
• Excellent interpersonal, as well as written and verbal communication skills to interact with a diverse population. Excellent phone etiquette skills.
• Ability to work independently. Ability to maintain confidentiality.
• Experience completing clinical trials case report forms via hard copy and online.
• Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.

Preferred Qualifications

• Certification as a Clinical Research Associate or Coordinator.
• Experience working with research bulk accounts.
• Experience with investigational drug authorization criteria.
• Experience providing including delegation, training, and leadership to staff.
• Knowledge of NIH, Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), HRPP, IATA Shipping of Blood Specimens, and Bloodborne Pathogens.
• Completion of courses or certification in leadership.

Special Conditions

• Employment is subject to a criminal background check and pre-employment physical.
• Occasional evenings and weekends may be required.
• Scheduled work hours may vary as this project follows subjects residing throughout North America and time zone differences require availability outside normal day-time working hours.

Pay Transparency Act
Annual Full Pay Range: $74,792 - $120,269 (will be prorated if the appointment percentage is less than 100%)
Hourly Equivalent: $35.82 - $57.60

Apply Now

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.