Clinical Research Coord.

Job Number 53568
Posted 3/29/2018
Account Eastern Maine Medical Center
Department Clinical Research
Location EMMC - Cumberland Place - Clinical Research, ME 04401
Schedule Regular Full-time
Shift Day
Hours 8:00-4:30
  • Maintains research data, participants files, regulatory binders and study databases, and provides initial interpretation. Patient accrual: screens all new patients daily -determines preliminary eligibility- informs physician- follows through with patients for possible entry into clinical trial. Maintain contact with programs/sponsors as necessary.
  • Collaborates with physicians, nursing staff, pharmacy , accounting to ensure that protocol registration-enrollment procedures are followed : current consent obtained, pre-study tests reported, final eligibility determined, investigational drugs on hand or plan to order; all protocol supplies on hand and appropriate billing is arranged (per CRC IDDs and federal guidelines)
  • Develops and implements recruitment/screening strategies. Administers scores and interprets study questionnaires. Educates and guides patients and families through the clinical trial consenting process according to the federal regulations and CRC IDDs.
  • Recommends protocol changes and prepares drafts of protocols, research summaries, educational materials and manuscripts. Acts as study resource for patients and family members; being available on call.
  • Collaborates with healthcare providers to accurately assess patient adverse events with the sponsors and the IRB.
  • Identify problems or obstacles in the system/procedures related to implementation of the study and communicate to the study investigators. Work with the Principal Investigator and Director of Clinical Research to develop study budgets.
  • Performs data analysis and QA/QC data checks.
  • Conduct or coordinate training for participants, schedule participant appointments, and maintain contact with study participants as necessary.
  • Collaborates with the laboratory and other personnel to facilitate the processing and shipment of required laboratory specimens. Seek certification in shipping of laboratory specimens.
  • Collaborates with the Lead Clinical Research Coordinator and Director of Clinical Research to develop educational and marketing materials. Act as a resource to other EMMC departments.
  • Maintains an effective system facilitating completion of clinical trial requirements: appropriate timing of care, minimizing missed required events timely submissions of required data including tracking deadlines for program components.

MINIMUM EDUCATION REQUIRED: Bachelor's Degree. Certification as a Clinical Research Professional required within 2 years of hire.

MINIMUM EXPERIENCE REQUIRED: Two years' experience conducting clinical trials or five years' experience with patient care.



· Demonstrated excellent oral and written communication skills.

· Strong critical thinking, problem solving and attentiveness to detail.

· Knowledge of anatomy and physiology and medical terminology.

· Ability to prioritize work.

· Experience with Microsoft office (Excel, Access, and Power Point).

· Must have administrative, interpersonal, organizational, and time management skills.

· Ability to follow guidelines, instructions, as well as work independently.

· Ability to communicate effectively and clearly about research

· Ability to interact effectively with physicians and various other professionals.

· Knowledge of regulations and GCP guidelines relating to clinical research and human subjects protections

· Knowledge of IRB processes and procedures

· Ability to read/interpret written study reports and research data

PHYSICAL REQUIREMENTS: Visual acuity; above average manual dexterity; keyboard data entry,; viewing computer monitor; bending; lifting , pulling, reaching; able to communicate verbally and have auditory function to communicate by telephone; able to sit for > 90% of the workday; able travel independently

WORKING ENVIRONMENT: Clinical and Office Setting

Equal Opportunity Employment
We are an equal opportunity, affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, disability status, gender, sexual orientation, ancestry, protected veteran status, national origin, genetic information or any other legally protected status.