clinical research associate Gaithersburg, MD
Job description
This is a full-time position that involves direct contact with psychiatric patients participating in clinical trials. Additionally, the clinical research coordinator will have contact with Pharmaceutical Companies (sponsors), Contract Research Organizations (CROs), Institutional Review Boards (IRBs), community organizations, vendors, and CBH staff. Each employee will be oriented and trained in their responsibilities as the clinical research coordinator caring for research participants and representing CBH with affiliated organizations.
Under direct supervision and guidance of the Director of Clinical Operations, the clinical research coordinator is responsible for the planning, execution and successful completion of clinical research protocols within inpatient and outpatient environments. The clinical research coordinator supervises the clinical research assistants assigned to studies within the scope of the clinical research assistant’s responsibilities.
Age Statement:
The Clinical Research Coordinator is an integral part of the research team. The clinical research coordinator demonstrates knowledge of the principles of growth and development appropriate to young adults through geriatric populations. Additionally, the clinical research coordinator demonstrates competency in applying these principles when providing individualized care for research participants.
Objectives: At the completion of the 90 days probationary period, the new employee will be able to:
1. Present an understanding of treatment components and how the role of the clinical research coordinator fits into the delivery of services.
2. Demonstrate excellent communication and interpersonal skill as evidenced by collaboration with other members of the staff/ supervisors, direct contact with research participants during evaluations, and good rapport with Pharmaceutical Company/ CRO.
3. Understand and observe CBH standard operating procedures (SOPs), clinical research unit policies and perform responsibilities in a competent and professional manner.
4. Understand and demonstrate strong knowledge of GCP, FDA and IRB guidelines/requirements for the conduct of clinical research.
5. Demonstrate knowledge and application of all components for preparation, execution and completion of a clinical research protocol.
Supervision: Reports to Director of Clinical Operations and Medical Director
Responsibilities:
§ Review and demonstrate complete proficiency with the assigned protocol and seek clarification of any issues/concerns related to protocol requirements, schedule of visits/procedures, and execution of research plan through the proper chain of command.
§ Demonstrate complete and accurate documentation skills, excellent communication skills and attention to details.
§ Create and present the initial and ongoing protocol trainings to the research team and contracted staff. Document dates of training and signatures of study personnel trained on study specific training logs.
§ Assure that all study personnel have met training requirements (including but not limited to study raters, data entry personnel, vendors, etc).
§ Create and modify CBH source documents for specific protocols.
§ Ensure all aspects involved in the proper conduct of a trial are in place prior to the enrollment of research participants.
§ Screen potential research participants for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
§ Complete the informed consent process with potential research participants, caregivers/LARs, witness, and Investigator.
§ Collect and review past/ present medical and psychiatric history from research participant, family, case manager, health care provider, recruiters, psychiatrist and old medical records. Document accurate and complete information in source from all the history obtained.
§ Provide clinical care/ assessments for research participants. Demonstrate proficiency with vital signs, phlebotomy, lab processing, storage, shipment, and ECG acquisition and transmission, as well as any other clinical requirements as specified per protocol.
§ Receive, store, assign, dispense and collect investigational products. Perform study drug accountability and temperature control monitoring.
§ Maintain adequate inventory of study supplies through ordering, receipt, inventory and storage process (this may involve lifting/moving supply boxes, etc). Organize space for study equipment and supplies.
§ Monitor and communicate to investigator clinical test results, medication needs, potential adverse events and any other relevant events in a timely manner.
§ Ensure that the P.I. and sub-investigators complete necessary ratings, notes, procedures, lab/ECG and potential adverse event evaluations as specified in a protocol.
§ Assist the investigator in promptly reporting any identified noncompliance or unanticipated problems involving risks to research participants or others to the sponsor/CRO and IRB.
§ Demonstrate knowledge of regulatory requirements by assisting in maintaining regulatory documents per FDA, Sponsor, IRB, and CBH guidelines.
§ Assist with preparation of the initial and ongoing regulatory submission documents to institutional review boards (IRBs) and sponsor/ CRO as required (most regulatory requirements will fall upon the manager of regulatory affairs, however knowledge of the process is expected of the clinical research coordinator)
§ Collect and manage study data as required by protocol, including CBH generated forms, sponsor generated source and case report forms (CRFs), study drug accountability and petty cash/ subject stipend records. Respond to sponsor generated queries in a timely manner.
§ Perform consistent quality control audits of study data and report any instances of noncompliance to director of clinical operations and manager of quality control.
§ Maintain effective and ongoing communication with CBH research team, sponsor/CRO, vendors and research participants during the course of the study.
§ Travel to investigator meetings and academic/professional conferences as required.
§ Schedule and assist sponsor/ CRO representatives during site visits.
§ Assist in preparing for study closure and archiving.
§ Adhere to and support all Federal regulations and CBH policies instituted to safeguard protected health information (PHI).
§ Assist with the creation, review and revision of CBH SOPs and CRU Policies as needed.
§ Maintain licenses, certifications, and trainings as required for the CBH training program.
§ Be willing and available for after-hours emergencies.
§ Other duties as instructed by supervisors.
Minimum Qualifications:
§ BS in psychology or a field related to health science, BS in Nursing, R.N. or foreign MD preferred.
§ Prior research experience coordinating clinical trials is highly preferred.
§ Experience working with chronic mental illnesses in an acute care setting.
§ Computer/Technology proficiency required. Must be able to demonstrate proficiency with tablets, phones, laptops, etc...
§ Candidates must be able to multitask, have meticulous attention for detail, strong organizational and interpersonal skills, ability to demonstrate knowledge and skill in techniques of good clinical judgment and problem solving, be a team player and be flexible.
Physical Demands: While performing the duties of this job, the employee is regularly required to stand; walk; sit; talk and listen. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 25 pounds.
This description is intended to provide only basic guidelines for meeting job requirements. Responsibilities, skills and working conditions may change as business needs evolve.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Job Type: Full-time
Pay: $50,000.00 - $60,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
- No weekends
Ability to commute/relocate:
- Gaithersburg, MD 20877: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Clinical research: 1 year (Required)
- working with mental illnesses in an acute care setting: 1 year (Required)
Work Location: In person
About JBR Clinical Research
Revenue: $1 to $5 million (USD)
Size: 51 to 200 Employees
Type: Company - Private
Website: www.jbrclinicalresearch.com
