Duties and Responsibilities:
- Under supervision from a Clinical Research Coordinator, manages and executes CRP/IRB submissions for initial approvals, continuing reviews, amendments, protocol deviations, and adverse events. Ensures timeliness and accuracy of all submissions.
- Oversees and conducts the screening and informed consent processes for research studies. This includes phone and face-to-face interactions with patients. Updates screening tracking worksheets on a routine basis.
- Administers surveys (phone/email/in-person) and coordinates research-related visits and follow-ups with all relevant multidisciplinary teams. This may involve off-site visits at sports organizations and other locations.
- Ensures subject/investigator compliance with research procedures and escalates issues to supervisor as needed.
- Manages data collection specific to research studies. This includes the supervision of multidisciplinary teams involved in the successful conduct of the study. Performs audit and quality checks on a routine basis to make sure data entry is up to date and complete.
- Compiles final dataset for analysis and assists in the interpretation and summarization of results.
- Provides updates on study progress to supervisor and Principal Investigators.
- Participates in the preparation of manuscripts for publication and abstracts/presentations for conference meetings.
- Assists with literature searches, as necessary.
- Maintains and enhances professional growth through participation in seminars, educational sessions hosted by Clinical Research Administration, and Physiatry Grand Rounds.
A qualified candidate has the ability to communicate in an effective manner with management, clinical staff, and patients at HSS.
- Requires a Bachelor's degree in life sciences or a related field.
- Excellent interpersonal skills as well as written and verbal communication skills.
- Strong organizational skills with ability to work independently.
- Exceptional time management skills.
- Ability to interact with all levels of management, physicians, medical, and administrative personnel.
- Experience in clinical research and knowledge of GCPs, HIPAA, 21CFR, and ICH is highly preferred.
- Proficient computer skills in Microsoft Office Suite.
- Prior experience with EPIC is preferred, but not required.
- 1-2 years of experience in clinical research
- Proficient use of computers and software
- Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus.
- Knowledge of EPIC is a plus.