Under limited supervision, demonstrates capacity to work independently in performing a range of routine to complex, clinical and/or non-clinical activities associated with conducting clinical research for assigned research project(s). Ensures integrity, quality control and compliance with all protocols associated with assigned project(s). Collaborates with Principal Investigator, and other members of assigned research projects to achieve project objectives relating to lab procurement and processing and other study related activities.

MANAGEMENT AND COORDIANTION OF STUDY SPECIMENS:

Coordinates and facilitates the collection of clinical research specimens both with the research staff and external sources.

Processing and shipping of clinical study specimens according to the IRB approved protocol.

Provides transportation of specimens when needed.

Provides support services for assigned research projects and research staff.

Collaborates with Principal Investigator to ensure timely processing and shipment of all lab samples.

Follows-up and resolves any issues pertaining to sample collection.

Prepares study reports and perform laboratory inventory.

Ensures study specimen procurement supplies are up to date and in stock for each study: creating logs for sample collection, and by maintaining databases and sample tracking.

STUDY MANAGEMENT AND COORDIANTION:

Coordinates and manages study visits with other research staff members.

Collaborates with the Principal Investigator on identifying potential study subjects.

Works with other research staff to enroll and managed study participant study visits.

Tracks time to complete study tasks for reporting purposes for grant funded studies.

Develops tools to track study visits and tasks needed

Collects, compile clinical data according to established protocol

STUDY COMPLIANCE:

May receive training in clinical procedures (e.g. phlebotomy, taking vital signs, etc) or other tests deemed appropriate per research protocol from higher-level research personnel. After competency in procedure(s) has been demonstrated, independently performs assigned clinical procedure(s).

Prepares all necessary materials required for audits or monitoring visits and study initiation meetings;

Receives training in designated research protocols, procedures and techniques; and, participates in site initiation, pre-site study and investigator meetings as needed.

Demonstrate the knowledge of age related differences and needs of subjects in appropriate, specific populations form neonate through adolescences and applies them to practice. Demonstrates cultural sensitivity in all interactions with subjects/families.

Values cultural diversity and other individual differences in the workforce.

Demonstrates support for the mission, values, and goals of the organization through behaviors that are

consistent with Connecticut Children's standards.

Performs other related responsibilities as assigned.

SUPERVISORY RESPONSIBILITIES

May provide oversight to study personnel in specific areas of assigned project (s).

Bachelor's degree in a health care related field plus a minimum of three (3) years of clinical research lab experience. Degrees in other areas may be substituted on a case-by-case basis.

Substitution allowed: Five years' relevant clinical research laboratory experience OR an Associate's degree with four years of relevant clinical lab experience.

Position Specific Job License and/or Certification Required

Safe-Pack Training for shipping hazardous materials if managing study specimens.

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

KNOWLEDGE OF:

Research protocols, principles and procedures. Ability to read in interpret lab manuals

Ethics and regulatory procedures (e.g. informed consent, IRB applications, data safety and monitoring plans) involved with clinical trials and other clinical research

Aspects of clinical trials such as screening, interviewing, case report forms

Experimental design, mathematics, statistics, computer applications and computer data management

SKILLS:

Project management, interpersonal and organizational skills

Excellent oral and written communication skills

Demonstrated proficiency in Windows environment; intermediate to advanced level word processing and spreadsheet skills (Microsoft Word & Excel); and intermediate to advanced skills developing presentations (Microsoft Power Point); intermediate to advanced skills in database design and database management (Microsoft Access)

ABILITY TO:

Work both independently and as a member of a project team.

Work with limited supervision and take responsibility for decision-making in area of expertise

Independently organize, analyze, and interpret data for decision making

Attend to detail, problem solve, be organized, and work in a fast-paced environment

Work Environment:

Both clinical and non-clinical work environment