Clinical Research Assistant II, Psychiatry, Mood Disorders

Clinical Research Assistant II – Psychiatry Department – Mood Disorders Division

Departmental Job Description

In addition to the job as described in the official job description some duties assigned to this position will include:

• Provide support to the Hub team through management of Network publications

• Assist with manuscript submission/resubmission

• Development of Network resources and training manual

• Communicate with study leadership; provide administrative support to TX-YDSRN team.

Ideal candidate will have: Experience in both clinical and research study settings, Strong written and oral communication skill, Detail oriented person who can provide with experience in editing and submitting manuscripts and presenting data to various stake holders.

Experience and Education

• High School and 2 years of experience, Associate’s degree in medical or science related field and 1 year of experience, or Bachelor’s degree in medical or science related field and no prior experience. 

• A minimum of Heart Saver for non-licensure or BLS for Licensure may be required based on affiliate location requirements.  

Job Duties

May perform some or all of the following based on research study:

• Understands visit schedules, inclusion/exclusion criteria and protocol requirements for low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.

• Assists research staff by completing research protocol related tasks. Reviews and abstracts information from medical records including eligibility criteria.

• Enters data into case report forms or other data collection system based on research study. 

• Assists with maintenance of study level documentation.

• Assists with data queries and possible edits for accuracy.

• Compiles data for regulatory requirements and /or deadlines for local or sponsor submissions.

• Maintains existing databases and ensures data integrity. Performs QA/QC clinical analysis and data checks using various databases based on trial.

• Assists with preparing annual reports and/or modifications to institutional review board (IRB).  This may include reportable events (UPIRSO).

• Assist and prepare research records for formal sponsor audits or internal audits.

• Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.

• With adequate training and supervision, assists with participant screening and recruitment for more complex trials.

• Conducts and documents consent for participants in studies. 

• Assists with the development of consent plans and documents for participants. Identifies incomplete, inaccurate, or missing data for more complex studies and works with lead coordinator to correct errors.

• Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order.

• With adequate training and supervision, assists with collecting and processing specimens following established procedures/protocols.

• Assists in preparing studies for closeout, (e.g. packing files, documenting files for storage, shipping extra supplies back to sponsor).

• With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG’s needed for research study. 

• Based on research study, other procedures/equipment/services may be required. May perform patient care (basic skills) under the direction of PI following scope of work document.

• Duties performed may include one or more of the following core functions:  a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records. Performs other duties as assigned.    

Knowledge, Skills & Abilities

• Knowledge of applicable Federal and institutional regulations governing clinical research.

• Knowledge of clinical research protocols.

• Effective organizational skills and attention to detail.

• Proactively works to maximize results of the team and organization.

• Follows and understands the regulations for Protected Health Information (PHI).

• Proactively works to maximize results of the team and organization.

• Possess strong computer skills (spreadsheets, databases, and interactive web-based software).

• Possess good communication skills.

• Possess the ability to problem solve.

• Work requires ability to conduct interviews with research subjects.