Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.
- Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
- Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data;
- Attend all relevant study meetings;
- Recruit and screen patients for clinical trials and maintain subject screening logs;
- Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits;
- Design and maintain source documentation based on protocol requirements;
- Record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness;
- Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics;
- Monitor subject safety and report adverse reactions to appropriate medical personnel;
- Correspond with research subjects and troubleshoot study-related questions or issues;
- Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards;
- Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring.
- Record, report and interpret study findings appropriately to develop a study-specific database.
- Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.
- Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
- Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
Required Knowledge, Skills And Abilities
- Knowledge of clinical trials
- In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules
- Knowledge of medical terminology
- Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word
- Excellent interpersonal skills
- Ability to pay close attention to detail
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- A High school diploma and 1+ years’ relevant work experience in a clinical environment or medical setting is required but a BS degree would be preferred (or equivalent combination of education, training and experience).
- Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies.
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything