CLINICAL PROGRAM MANAGER: Job Code C-05
THERAPEUTIC AREA of INTEREST: AUTOIMMUNE.
SUMMARY:
The Clinical Program Manager works within the Department of Clinical Operations to manage clinical studies that are designed to establish the safety and effectiveness of Company's products. This person initially will focus on early clinical development, but will have the ability to bring one or more of these products to Phase III development, as necessary. Skills required include study planning and training, study initiation, study management, and completion of final clinical study reports. Liaison with potential clinical investigators and management of Contract Research Organizations and other clinical resources is a significant aspect of this position.
RESPONSIBILITIES:
* Develop clinical development plans and study timelines. Participate in the development of clinical protocols, Investigator Brochures, consent forms, training material, and other clinical documents, as required by the project.
* Provide a liaison function between clinical investigators and scientific personnel in the development of programs and clinical studies.
* Arrange and manage resources to conduct clinical trials, including Contract Research Organization and Consultants. This will involve identifying and selecting resource providers and evaluating these services on an ongoing basis. Coordinate with other functional areas (e.g., Regulatory Affairs, etc.)
* Identify and evaluate clinical investigators; monitor the progress of investigators on an ongoing basis
* Keep to project timelines. Propose and implement solutions to problems that either jeopardize the schedule or the quality of the studies. Make sure that all tasks are completed that contribute to the conduct of a clinical study.
* Provide support for Clinical Operations, as required. This could include writing and reviewing department and company SOPs, maintain files, contribute to regulatory filings, etc.
REQUIREMENTS:
* BA degree required, advanced degree (e.g., MS, MPH) desirable. 3-5 years industry experience in clinical research. Previous management of investigator-initiated and early clinical development desirable.
* Training and experience in Good Clinical Practices; excellent written and oral communication skills, familiar with word processing, database, and tracking software

CLINICAL PROJECT MANAGER: Job Code C-06
SEVERAL POSITIONS with SEVERAL OF THE PREMIER Mass. based Companies. Areas of interest include: ONCOLOGY, INFECTIOUS DISEASE, CARDIOVASCULAR, METABOLIC AND ENDOCRINOLOGY.
Where is your interest? If you have 5-10 years minimum trial monitoring experience you will want to contact us now for more information!
MISSION STATEMENT:
Responsible for managing the development, initiation, conduct, monitoring and completion of clinical studies.
SPECIFIC RESPONSIBILITIES:
1. Provide operational perspective to planning of clinical studies.
2. Generate timelines for initiation to completion and reporting of clinical studies.
3. Coordinate generation and assembly of all documentation associated with clinical studies.
4. Participate in site selection and qualification.
5. Negotiate investigator and CRO budgets in collaboration with Finance Department.
6. Coordinate all GCP activities from site selection through data completion and regulatory site audits with CROs.
7. Conduct site audits and perform periodic site visits.
8. Plan, monitor and report patient accrual and implement corrective actions as necessary to meet accrual targets.
9. Coordinate production, labeling and delivery of clinical supplies with Operations Department, external labeling company, and investigational sites.
10. Coordinate documentation and changes with Regulatory Affairs to assure appropriate regulatory agency approval.
11. Supervises activities of external Contract Research Organizations and investigational sites.
REQUIREMENTS:
1.) Requires significant biological and/or clinical science background.
2.) Requires a BS degree (advanced degree preferred) in a scientific or health care field (e.g., nursing, pharmacy, physician's assistant.)
3.) Minimum 5 years in biopharmaceutical or device industry, CRO or academic/hospital clinical research environment.
4.) Required to have direct clinical research experience and to have supervised clinical studies as project leader or senior clinical associate.
5.) Requires management and negotiation skills in a team environment.
6.) Requires superior interpersonal and written/oral communication skills.

SR. CLINICAL RESEARCH ASSOCIATE
Job Code C-07
RESPONSIBILITIES:
Working independently, under minimal supervision, the Senior Clinical Research Associate will be responsible for all operational aspects of implementation and conduct of clinical studies including study planning, implementation, monitoring and completion activities. A travel commitment will be required. The key responsibilities of this position will be to contribute to the development of clinical programs including protocols, study procedure handbooks, and case report forms; to insure compliance of study activities with FDA regulations, Guidelines and principles of Good Clinical Practice. Along with the Medical Monitor, you will be responsible for study site selection; patient accrual, documentation of protocol violations; tracking study progress via standard reports; and management of adverse event reporting. May participate in all phases of clinical monitoring from site qualification to site closure visits and assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. Ensure sites meet project timelines; develop study budgets and negotiate grants and contracts; maintain study documentation according to FDA guidelines and SOP's both on-site and in-house; and provide input to medical reports and Investigator Drug Brochures including data cleanup, listing review, and other input as requested.
EXPERIENCE:
The ideal candidate will have a B.S., R.N., B.S.N. degree or equivalent and a minimum of 2-4 years experience in clinical study management. Knowledge of GCP and FDA regulatory requirements and excellent organizational ability are required, as are good oral and written communications skills.
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