Job Description

Manages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and standard operating procedures. Coordinates start-up activities, launch activities, day-to-day management of a study, and study closure activities. Trains and mentors other CRC’s to ensure consistency in study management activities.

Essential Functions:

• Conducts clinical studies as outlined in the study protocol and adheres to good clinical practices. Assists with study recruitment plans and provides input into the budget. Assists with responsibilities for regulatory/IRB issues after a study has been initiated. Maintains regulatory binder.
• Recruits, consents, and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations, and departmental quality control guidelines. Answers questions, acts as a patient and family advocate, and participates in retention of enrolled research participants.
• Coordinates and schedules subject study visits, manages protocol required data, and performs study procedures according to recognized skill level and certifications while within local and federal regulations and guidelines.
• Identifies study implementation or study management issues and collaborates to develop and implement solutions that ensure study progress and success. Educates other study personnel regarding study-specific responsibilities and keeps written documentation.
• Manages all screening, enrollment and study participation logs, ensures inclusion and exclusion criteria, and alerts related to safety issues, protocol deviation, and premature study termination. Completes recruitment summary at study termination.
• Creates source documents that facilitate systematic data collection or aid in protocol execution, management, and record keeping. Conducts accurate and timely subject data collection and assists with database development to maintain data in de-identified format.
• Assists the principal investigator in the preparation of scientific publications and grant proposals.
• Conducts clinical interviews, in-person, virtually and over the phone. Examines past and collects current mental health history and behavior. Contacts appropriate Crisis Services when required by study protocol.

Education Requirement:

• BA/BS, required.
• Degree in social science, health or behavioral field, preferred.

Skills:

• Understanding of clinical research preferred.
• Working knowledge of PCs and word processing and data management software.
• Demonstrated analytical skills with accuracy and attention to detail.
• Excellent verbal and written communication skills.
• Goal-oriented and self-directive, ability to manage complex projects independently.
• Strong organizational and interpersonal skills.
• Ability to actively participate as a team player.

Experience:

Eighteen months experience in clinical research or health care field, required.

Physical Requirements:

OCCASIONALLY: Cold Temperatures, Driving motor vehicles (work required) *additional testing may be required, Fume /Gases /Vapors, Loud Noises, Reaching above shoulder, Squat/kneel

FREQUENTLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Communicable Diseases and/or Pathogens, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Machinery, Patient Equipment, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Sitting, Standing, Walking

CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing – Far/near

"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"